United StMM
Environment*! PraMctlon
PtltlcidM and Toxic Sut»uno«
WwhingtonDC 2O460
Pwticidw
June 1985
&EPA
Guidance for the Reregistration
of Pesticide Products
Containing Nitrapyrin
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GUIDANCE FOR THE
REREGISTRATION OP PESTICIDE PRODUCTS
CONTAINING
AS THE ACTIVE INGREDIENT
NITRAPYRIN
(GS-0213)
(069203)
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
JUNE 1985
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NITRAPYRIN REGISTRATION STANDARD SUPPORT TEAM
Timothy Hunt Office for Policy, Planning and Evaluation
Robert McLaugh].in Office of General Counsel
Richard Green Office of Canpilance Monitoring (OPTS)
Francine Jacoff Office of Solid b ate
Marion Thanpson Office of Water
Charles r los Office of Water Regulations and Standards
Arthur Schloaser Exposure Assessment Branch (HED)
Robert ?ilsucki Ecological Effects Branch (NED)
William Hazel Residue Chamistry Branch (NED)
William Woodrow Toxicology Branch (NED)
Willa Garner Science Integration Staff (NED)
‘flunas irkhalter Science &apport Branch (BUD)
Gary Ballard Econanic Analysis Branch (BUD)
William Grosse Information Services Branch (PM D)
Arty Williams Program Coordination Staff (RI))
Lawrence Schnaubelt Product Managament L am 23 (RD)
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TABLE OF CONTENTS
Introduction . . . . . . . . . . . . . . . . . . . . . . 1.
I. Regulatory Position arri Rationale. . . . . . . . . . . .
II. Requirement for Sutzni8aion of Generic t ta . . . . . . . 23
III. Requirement for Sutinission of Product—Specific
t .ta . . . . . . . . . . . . . . . . . . . . . . • . . • 147
IV. Sutinisslon of Revised Labeling . . . . . . . . . . . . . 50
A. Label Contents . . . . . . . . . . . . . . . . . . . 50
B. Collateral Information. . •1• . . . . . . .56
V. InstructionsforSutinlsslon. . . . . . . . . . . . . . .56
I
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APPENDICES
Page
II — ]. Guide toBibliography •....... •ISS•
11—2 Bib1iograp1 . • • • • • • • . . . . . . . . . . . . . 62
11—3 FIFRA 3(c)(2)(B) Suninary Sheet — EPA Fonn 8580—1 . . 69
II LI Certification of Attempt to & iter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580—2 • • • • • • • • • • • • • • . . . . 70
]:II—1 Product Specific Data Report (Ens—Use Products) . . •
I r—]. L o CFR 162.10 Labeling Requirements . . . . • • • • • 73
IV—2 Table of Labeling Requirements. . . . • • • • • • • 82
IV—3 Physical/Chemical Hazards Labeling Statement. . . . . 86
Storage ar 1 Disposal Instructions . • • • • . . . . 87
ii
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA sec. 3(g)) directs EPA to reregister all pe8ticide8 as
expeditiously as possible.
¶fl carry out this task, EPA has established the Regis—
tratiai Standards program, which will review all pesticide
products containing active ingredient8 first registered before
January 1, 1977. Pesticides will be reviewed In use clusters
which have been ranked to give earliest review to pesticides
used on food and feed crops.
The Registration Standards program Involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was Initially registered or studies that are now considered
insufficient. EPA’s reassessment results In the development
of a regulatory position, contained In a Registration Standard,
on each pesticide and its uses • The Agency may require the
registrant to modify product labels to provide additional
precautionary statements, restrict the use of the pesticide
to certified applicators, provide reentry Interials, modify
uses or formulation types, specify certain packaging limitations,
or other requirements to assure that proper use of the pesticide
will not result In adverse effects on the envlrciiment.
The scientific review, which is not contained In this
Guidance Package but is available upon request, concentrates
on the technical grade of the active ingredient end identifies
missing generic data. However, during the review of these
data we are also looking for potential hazards that may be
associated with the end use (formulated) products that contain
the active ingredient. If we have serious concerns, we will
address end use products as part of the Registratlcn Standards
program and will propose regulatory actions to the extent neces-
sary to protect the public.
EPA has the authority under FIF A sec. 3(c)(2)(B) to
require registrants to suth it data that will answer our
questions regarding the hazard that may result fran the
intended use of a pesticide. Although sec. 3(c)(2)(B) provides
that all registrants are responsible for these data, the
Agency generally Imposes generic data requirements only on the
registrants of the manufacturing use products (basic suppliers
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of the active ingredient) and other producers who do not
qualify for the formulator’s exemption.*
A roducer who wishes to qualify for the formulator’s
exemption may change his source of supply to a registered
source, provided the source does not share ownership in
camnon with the registrant’s finn. A registrant may do 80
by sutmltting a new Confidential Statement of Formula, EPA
Form 857o-L , identifying the registered source of the active
ingredient, to the appropriate Product Manager wIthin 90
days of receipt of this Guidance Document. The chart on the
following page shows what is generally required of those who
do and do not qualify for the formulator’s exemption In the
Registration Standards program.
If you decide to request the Agency to cancel the regis-
tration of any of your products subject to the requirements
of this Guidance Document, please notify the Product Manager
named in the cover letter, within 90 days from the receipt
of this document • If you decide to maintain your product
reglstraticn(s), you must provide the information described in
the following pages within the timeframes outlined. EPA will
Issue a notice of intent to cancel or suspend the registration
of any currently registered product which does not comply
with the requirements set forth In this Guidance Document.
You are reminded that FIPRA Sec. 6(a)(2) requires you to
suhelt factual information raising concerns of possible
unreasonable adverse effects of a pesticide. You should
notify the Agency of interim results of studies in progress
if those results show possible adverse effects.
*The formulator’s exemption applies to a registrant of a
product If the source of his active ingredlent(8): (1) I a a
registered product and (2) is purchased from a source which
does not have ownership In caiinon with the registrant’s
fi nn.
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p,-’.. j I ;
pI nL,rs SUBJ P ¶LU ¶I IE
R I 1! ATION 31 ANDAR1A5 PM
N ION(S) TO
MAINTAIN REGI ATION
I. Products 11 t Do I t ialify
For ¶lhe Formulator’s Ex it1on
A. S1I Ie Active Ir€redlent
Products’
• .•.....•.............•••••••••••••
B. *iltiple Active Ir redient
Products
l se products must be reregis-
tered. To obtain reregistration,
labeli%, pac1€ag1r ar data
requirements must be satisfied
in accordance with the I gis-
traticn Star arda Guidance
Doc .snmit.
. .. .........•...•• ........••.•••••
These products will not be
reregister’ed at this time.
Ibwever, generic data required
to continue the registration of
the active ingredient tuler
review, as described in the
R istraticn Star*iarda Guidance
Docunent, will be required arvi
sane ].abeling precautions may
also be required.
U. Products 1 *t lb .ialify For
l Formulator’s Ejc , 4 iLicn
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(kily when additional restric-
tions or labellr€ are needed to
protect man or the envircnnent
will these products be subject
to the flegiatration Staniard
requirements. Affected products
will be dealt with in a variety
of ways, Including but not
limited to the label Improv it
Program sni special intent
to cancel notices.
. .laê.4a
*& 1 use products or wbo also produce a mamiracturll€
use product will not be required to be reregistered provided t t
registrant fulfills the requirements specified In the Guidance
Ibctsnent for marvfacturing use product(s). Such erd use products
will be subject to U labeling chenges required for products In “II”
above • It there are no menutacthring use products registered by any
ompeny ervi use products will be required to be reregistered.
1iYIE: If all registrants in “I” above rail to meet the requirements in
I-A and B above, then the registrants in “II” lose their right to
quslify for the fbrmulator’s exes tion ani becane subject to the
requir nts In I-A ani B.
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I. RBXBJLATORY PQSITION AND RATIONALE
A. Introduction
This Registration Standard describes the regulatory
position of the Envirorinental Protection Agency (“the Agency”)
on nitrapyrin based on an evaluation of the one manufacturing-use
product (M I ’) with nitrapyrin as the sole active ingredient and
the registered nitrapyrin uses. Future requests for registrations
of substantially similar products containing nitrapyrin as the
sole active ingredient will be covered by this Standard After
briefly describing the chemical and its uses, this chapter presents
the regulatory position and rationale, the criteria for registration,
acceptable ranges and limits, labeling considerations and tolerance
reassesament.
B. L acrIptIon of Chemical
Nitrapyrin is the cannon name for 2—chloro—6— (trichioro-
methyl) pyr’idirze as recognized by the American National Standards
Institute. The trede name Is N-Serve • The (] emical Abstract
Service Registry Number (CAS) 18 1929-82-4 and the Agency’s
Chemical Code N zi er Ia 069203.
Nitrapyrin is a white crystalline solid with a mildly
sweet odor. The melting point is 62—63°C. The solubility of
nitrapyrin at 20°C is 198 grams (g)/l0O g in acetone and 185
g/l00 g In methylene chloride; and at 22°C is 30 g/100 g In
ethanol, 54—67 g/l00 g in anhydrous amnonla, and 0.004 g/100 g
in water. The vapor pressure is 2.8 x io3 mn Hg at 23°C.
l 5 4ltrapyruln is a bacteriostat used to delay the nitrificatlon
of winonlacal and urea nitrogen fertilizer in the soil by control-
ling the nitrification process through selective activity against
the Nltrosanonaa bacteria. Nitrapyrin is regIster for use on
corn, cotton, rice, sorghum, strawberries and wheat. Registered
products are a 90% active Ingredient (al) technical manufacturing-
use product, a 2 pound (ib) ai per gallon emulsifiable concentrate
and a 2 lb at per gallon soluble concentrate. Nitrapyrin is
soil-Injected or Incorporated during or ismediately following
application at rates ranging fran 0.25 to 1.0 pound al per acre.
C. Regulatory Position nd Rationale
Based on a review and evaluation of all available data
and other relevant information on nitrapyrin, the Agency has
detennlned the following:
I • The existing data base 18 insufficient to fully assess
the toxicology, residue chemistry, environmental fate, or ecological
effects of nitrapyrin.
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Rationale: Major data gaps exist for this chemical.
Previous toxicity testing had been conducted using the major
metabolite 6-chloropicollriic acid and for many studies, previous
testing was found, upon reevaluation, to be supplementary (not
tested In accordance with current Agency testing guidelines) or
invalid. A suninary of conclusions that can be reached at this
time follows:
a. Nitrapyrin has been tentatively classified in
Toxicity Category III on the basis of acute oral
and dennal toxicity studies. Subchronic feeding
studies indicate a no-observed effect level (NOEL)
of 600 parts per million (ppm) in the dog and a
NOEL of 300 ppm in the rat.
b. Chronic feeding studies were previously conducted on
the metabolite 6—chioroploolinle acid (6-CPA) which
was Initially identified as the residue of concern
since metabolism studies In plants and animals using
Clii tagged nitrapyrin parent canpound resulted In the
production of 6-CPA. Subsequent testing showed
nitrapyrin se to be part of the residue on sane
crops • For this reason, and since parent nitrapyrin
Is metabolized to 6—CPA In both animals and plants,
testing of the technical grade active ingredient ( AI)
will demonstrate the toxic effects of both the parent
and metabolite(s), as well as Impurities in the ‘IUAI.
Therefore, toxicity testing is required using nitrapyrin
‘IUAI as the test substance.
c • Reevaluation of a chronic feeding/onoogenicity
study in the rat using 6-CPA indicated that signif-
leant canpound related microscopic changes (biliary
byperplasia) occurred in female rat livers at
all tested dose levels. The lowest dose tested
(LDT) was 30 ppm. Testing conducted at 100, 300,
and 1000 ppm dose levels indicated increased frequency
and/or severity of lesions with dose • No changes
were observed in the controls or treated males. Although
these data are inadequate (insufficient number of animals
tested, inccinplete reporting of necropsy data, and
incanplete clinical pathology) for assessment of oncogenic
potential or establislinent of a chronic NOEL, they are
useful as a basis for detenninlng a provisional acceptable
daily intake (PADI) for nitrapyrin. The previously
established nitrapyrin (6-CPA) NOEL, acceptable daily
intake (ADI), and maximum per nlssible intake (MPI) will,
therefore, have to be revised. (Refer to Section 0.
Tolerance Reassessment.)
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d. The plant and animal metabolism of nitrapyrin are
not adequately understood. Due to large amounts
(up to 85%) of unextractable or unidentified extract-
able material in plants, and depending on the results
of the requested plant metabolism data, the analytical
methodology may need to be revised. Animal metabolism
studies testing nitrapyrin se and its 6-CPA metab—
olite are required. Storage st ility data, and
additional, more geographically representative residue
data are required for most ccamoditles. (Refer to
Section 0. Tolerance Reassessment for a listing of
established tolerances for nitrapyrin and 6-chloro-
picolinic acid.)
e. Preliminary data indicate that hydrolysis of nitrapyrin
is rapid (half—life of < 2-8 days), the rate increasing
with tanperature (25—1 5°C). It is not affected by pH (3.2—
8.11); however, it degrades more rapidly in the light than
in the dark. In aerobic soil, nitrapyrin has a half-life
of 11—30 days, and in anaerobic soil, it has a half-life
of < 3 days. In the field under flooded rice culture
conditions, nitrapyrin degrades with a ha].flife of 7-35
days. It accumulates in the edible and visceral tissues of
bluegill sunfish with maximum bloconceritration factors of
33x and 60x, respectively. The residues depurate rapidly.
Data from the following studies are required to fully
assess the envirorinental fate arid transport of and the
potential exposure to nitrapyrin: hydrolysis;
photodegradatlon in water; aerobic aquatic metabolism;
leaching and adsorption! desorption; terrestrial arid
aquatic field dissipation; and accumulation in rotational
arid irrigated crops.
f. The application of nitrapyrin as a liquid should pose
no hazard to birds because it is incorporated into the
soil ininediately after application and acute toxicity
studies show it to be practically nontoxic • Based on
estimated envirorinental concentration (EEC) of 0.1 ppn
in water (due to runoff), the hazard to aquatic organisms
is expected to be minimal. Avian dietary and acute
freshwater fish toxicity data are required to fully
assess the effects of nitrapyrin on wildlife and aquatic
organisms.
2 • %* ile available residue chenistry and toxicology data
are insufficient to allow a tolerance reassessment, the Agency
concltx s that no charges in existing tolerances are indicated
at this the. However, no new tolerances will be established until
all major data requirdnents have been satisfied.
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Rationale: There is no basis on which to change
existing tolerances because available toxicology data have been
used to determine that current tolerances utilize 45.6% of the
provisional acceptable daily intake (PADI). Due to data gaps
an acceptable daily intake (ADI) cannot be calculated at this
time. Therefore, no new tolerances will be granted until data
are submitted and reviewed and existing tolerances are reassessed.
(Refer to Section G. Tolerance Reassessment.)
The rationale provided in #1 and #2 also supports
position #3.
3. None of the risk criteria set forth in Title IO Code
of Federal Regulations (CF ) §162.11 have been met or exceeded by
nitrapyrin.
4. The use of nitrapyrin in rice may impact on endangered
or threatened species. Additional data are needed before the Agency
can initiate formal consultation with the Office of ndangered
Species (OFS), USFWS.
Rationale: Although nitrapyrin use in rice 1.8 e8tlinated
to be negligible (use analysis indicates that 90—100% of nitrapyrin
produced between 1981 and 1983 was used in corn), nitrapyrin residues
at concentrations of 0.4 ppm (in floodwater) may result fran this use.
This level may impact on endangered or threatened species, such as
the Fat Pocketbook Pearly Mussel, which is a bottan dweller. As a
bottan feeder this species would be expo8ed to nitrapyrin in the water
as well as that adsorbed to sediments • Because the available aquatic
invertebrate toxicity data are not appropriate in aB8essing hazard
to bivalves, marine molluac shell deposition data are required.
As soon as these data are received and evaluated the Agency will
determine whether formal consultation with OSS Is necessary.
In the meantime the Agency is requiring a revised
environmental precautionary statement on the labels of all
manufacturing-use products. This statement places certain restrictions
on discharge of effluent containing nitrapyrin. (Refer to Section
F. 2 below.)
5. No unique h nan hazard precautionary statements,
protective clothing requirements, or reentry intervals are required.
Rationale: Acute oral and derma]. studies Indicate that
nitrapyrin has a relatively low toxicity (Toxicity Category III) and
there is no basis to require unique precautionary statements or
protective clothing requirements. Also, since nitrapyrin is soil-
Injected or incorporated during or lninedIately after application,
reentry intervals are not required.
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6. Current labeling restrictions for end-use products will
be maintained.
Rationale: Present label restrictions prohibit rotation
of non-labeled crops to treated areas within one year of application
and prohibit the use of irrigation water fran treated rice fields
for irrigation of non—labeled crops. These restrictions will be
maintained until such time as data which allow a determination of
the nature and amount of residue uptake in rotational crops and
crops expected to be irrigated with water fran a field treated with
nitrapyrin are received and reviewed. In addition, the present label
statement limiting use on strawberries to California will be
maintained. Expansion of this use to other areas will require
appropriate supporting data.
7. The erivirormental chemistry studies (hydrolysis, pk to-
degradation, mobility, metabolism and dissipation) are being required
in the minimum times necessary to conduct the tests and will be
evaluated on an expedited basis when received to assess the potential
for nitrapyrin to contaniriate ground water.
Rationale: Nitrapyrin per se has not been previously
identified as a potential ground water contaminant and in
monitoring studies conducted to date nitrapyrin residues have
not been found in ground water. However, one study using the 6-
CPA metabolite indicated a moderate potential for 6—CPA to
leach in loam soil • Therefore, these studies are being requested
on an expedited basis and will be evaluated as they are received.
The Agency will then determine if the registration(s) of
nitrapyrin will be affected.
8. Manufacturing-use pesticide products containing
nitrapyrin as a sole active ingredient may be registered for
sale, distribution and reformulation, subject to the terms and
conditions specified in this Standard. Registrants must provide
or agree to develop additional data, as specified in the tables,
in order to maintain existing registrations or to permit new
nitrapyrin registrations.
Rationale: In the absence of evidence indicating
that the use of a pesticide would cause unreasonable adverse
effects on the erivirorinent, the Agency can register or allow
the continued registration of a product for which necessary
data Is missing or inadequate. Issuance of this Standard provides
a mechanism for identifying such data needs. Data autmitted
to fill these gaps will be reviewed and evaluated. The Agency
will then determine if they will affect registration(s) of
nitrapyrin.
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D. Criteria for Registration Under This Standard
To be subject to this Standard, manufacturing-use
products must meet the following conditions:
1. Contain nitrapyrin as the sole active ingredient
and,
2. Cct fonn to the acute toxicity limits, product
canposltion, and use pattern requirements listed in Section E
of this document.
The applicant for registration or reregistration of
products subject to this Standard must canply with all terms
and conditions described in it, including caiinitting to fill
data gaps on a schedule agreed to by both this Agency and the
applicant. All applicants for regl8tratlofl under this Standard
must follow the instructions contained in this Standard and
canpiete and eutinit the appropriate forms within the time
specified.
E. Acceptable Ranges and Limits
1. Product Canposition Standard. TO be covered under this
Standard manufacturing-use products (MP) must contain nitrapyrin as
the sole active ingredient. Each MP formulation proposed for
registration must be fully described with an appropriate
certification of limits.
2. Acute Toxicity Limits. The Agency will consider
registration of technical grade products and manufacturing—u8e
products containing nitrapyrin with a Toxicity Category III for
all acute studies.
3. Use Patterns. To be registered under this Standard,
manufacturing-use products containing nitrapyrin may be labeled
for formulation Into end—use products for the cannodities listed
below. The attached index entry lists all registered uses, as
well as approved maximum application rates and frequencies.
a. Terrestrial, non—dctnestic, food use on: corn,
cotton, sorghum, strawberries and wheat
b. Aquatic food use on rice.
F. Required Labeling
Al]. manufacturing-use and end-use nitrapyrin products must
bear appropriate labeling as specified in 40 CB1 162.10. The guidance
package for this Standard contains information on label requirements.
In addition to the above, the following information must
appear on the labeling:
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1 • Use Pattern Statements
All manufacturing-use product labeling must list 8peciftc,
currently registered sites on which the product Is
intended for use after manufacture Into an end—use product
or the manufacturing-use product will be considered
ror manufacture into end-use product8 for all registered
use sites. Specific sites are listed In Section E.3,
Use Patterns.
2. PrecautIonary Statements
Statements Applicable to Manufacturing-Use Products
The following environnenta]. precautionary statement must
appear on all NP labels:
Do not discharge effluent containing this
product directly into lakes, atremns, ponds,
eatusries, oceans or public waters unless
this product Is specifically Identified and
addressed in an NPDES permit. Do not discharge
effluent containing this product Into sewer
systems without previously notifying the sewage
treathent plant authority. For guidance,
contact your State Water Board or Regional
Off ice of the &ivlrorunental Protection Agency.
Statements Applicable to Erxi-Use Products
The following chemical-specific restrictive statements
must appear on all EP labels:
a. “Crops listed on this label may be rotated In less
than one year fran the last application. All other
crops are not to be rotated In less than one year’
fran the last application.”
b. “Irrigation water fran treated rice fields can be
used only on the following crops: corn, cotton,
sorghum, and wheat.”
c • “Based on available residue data, use of’ N-Serve on
strawberries Is restricted to California.”
‘fte required label statements listed in this Standard must
appear on the labels of all J4Ps and EPa released for shipment within
one year of iaausrice of this document. All labeling requirements
must appear on all products in channels of trade within two years of
Issuance of this document. After review of data to be suhaitted
under this Standard, the Agency may impose additional label
requirements.
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G. Tolerance Reassessment
U.S. tolerances for residues of nitrapyrin [ 2—chloro—6-
(trichioranethyl) pyridine] and its metabolite, 6—chioropicolinic
acid in or on raw agricultural carinodities are as follows [ 40
CF 180.350]:
Carinodities Tolerance (ppm )
Cattle, fat 0.05
Cattle, mbyp 0.05
Cattle, meat 0.05
Corn, fodder 1.0
Corn, forage 1.0
Corn, grain 0.1
Corn, fresh 0.1
Cottonseed 1.0
Goats, fat 0.05
Goats, mbyp 0.05
Goats, meat 0.05
Hogs, fat 0.05
Hogs, mbyp 0.05
Hogs, meat 0.05
Horses, fat 0.05
Horses, thyp 0.05
Horses, meat 0.05
Poultry, fat 0.05
Poultry, mbyp 0.05
Poultry, meat 0.05
Rice, grain 0.2
Rice, straw 2.0
Sheep, fat 0.05
Sheep, mbyp 0.05
Sheep, meat 0.05
Sorghum, fodder 0.5
Sorghum, forage 0.1
Sorghum, grain 0 • 1
StrawberrIes 0.2
Wheat, forage 0.5
Wheat, grain 0.1
Wheat, straw 0.5
No Codex Alimentarlus CclTmlssIon Maxlrrnzn Residue Limits
or Mexican tolerances have been established for residues of
nitrapyrin. A Canadian tolerance of 0.1 ppm has been established
for residues of nitrapyrin se in or on corn, however, it is
not known If the specific residues determined are consistent
with the U.S. tolerance.
The theoretical maximum residue contribution ( 1RC) to the
human diet as a result of the existing tolerances is 0.0411
mgJday/1.5 kg of the diet.
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A tolerance rea.ssessrnent cannot be made at this time
because of the major data gaps associated with the residue
chemistry and toxicology of nitrapyrin.
Since reevaluation of the oncogenicity study in the rat
using 6—CPA found it to be invalid, the previously established
nitrapyrin (6—CPA) NOEL of 300 pçzn, the P DI, and the MPI values,
which were based on this study, are considered negated. A
provisions]. ADI (PADI) and MPI (PMPI) have been established
utilizing currently available feeding/oncogenicity studies.
The ADI for man is usually determined on the basis of a
no—observed effect level (NOEL) which has been established for
chronic toxicity in rats or dogs. In the absence of a valid
chronic feeding study, a PADI can be determined based on a NOEL
generated from an acceptable subchronlc feeding study, providing
that an appropriate mangin of safety is used. A safety factor
of 100 is normally applied when the PADI is based on a chronic
test, whereas a safety factor of 2000 is used when basing the
PADI on a subchronic test. Chronic studies, even those class—
if led as supplementary, may be considered in determining a PADI.
Taking into consideration the length of the chronic rat
feeding/oncogeniclty study, the canpound tested (I.e., 6—CPA),
and the fact that significant histopathological effects were
observed at the lc iest dose tested (30 ppm), the Agency has
selected a more appropriate safety factor of 1000 to be used
in determining a PADI.
Based upon all the above considerations, the PADI has been
calculated to be 0.0015 mg/kg/day. The PMPI is 0.09 mg/day.
Currently, the total EMRC stands at 0.0 4i1 mg/day/i .5 kg diet.
The current percent of the PADI utilized Is therefore 5.6%.
Tolerances have been proposed for resiiiues of nitrapyrin
and Its metabollte, 6—CPA, in or on the crop group cereal grains;
lettuce; potatoes; soybeans arid soybean forage and hay. Since
the existing toxicology and residue chemistry data base for
nltrapyrin is lnccmplete, the Agency has decided that no new
tolerances or exemptions will be established until all major
toxicology and res1 ue chemistry data requirements listed in
Table A have been satisfied.
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EPA Index to Pesticide Chemicals
NITRAPYRIN*
TYPE PESTICIDE : Nitrogen Stabilizer
POR.MULAT1ONS :
Tech (90%)
EC (2 lb £.i./gLL)
SC/L (2 lb a i./gal)
G I AL WARNINGS AND LD ITATI0NS : Nitrapyrin nitrogen stabilizer is cor-
rosive to aluminum components which may affect the operation of pumping,
mixing and application equipment. To minimize corrosion of equipment and
for maximum effectiveness do not store liquid nitrogen solutions contain
ing the emulsifiable concentrate formulation. Do not store anhydrous am-
monia containing the soluble concentrate/liquid formulation for any longer
than 3 weeks. Use the emulsifiable concentrate formulation within 72
hours of mixing and rinse equipment with water after each use. Nitrapyrin
must be injected or incorporated into the soil with fertilizer at a mini-
mum depth of 2 to 4 inches during or immediately after application. The
soluble concentrate/liquid formulation is an oil—soluble product that may
be used with anhydrous ammonia, dry amaonium and urea fertilizers. Do
not use the soluble concentrate/liquid formulation with fertilizers con-
taining nitrate, such as ammoniue nitrate, potassium nitrate or calcium
nitrate. Do not mix seeds with dry fertilizers impregnated with the sol-
uble concentrate/liquid formulation. The emulsifiable concentrate formu-
lation may be used with aqua ammonia, other liquid ammonica.i. or urea ni-
trogen fertilizer compositions or liquid animal wastes. Combustible: do
not use hot mix fertilizers. Do not contaminate water, food or feed by
storage or disposal. Only those crops listed on he label may be rotated
in ices than 1. year from the last application.
Livestock
0.05 ppm (meat, fat, and seat byproducts of cattle)
0.05 ppm (meat, fat, and meat byproducts of goats)
0.05 ppm (meat, fat, and meat byproducts of hogs)
0.05 ppm (meat, fat, and seat byproducts of horses)
0.05 ppm (meat, fat, and meat byproducts of poultry)
0.05 ppm (seat, fat, and meat byproducts of sheep)
“Tolerance established f or combined residue of nitrapyrin and its seta—
bolite, 6—ebloropicolinic acid.
Replacement Crop Tolerances : None.
TIME REQUIRED FOR C0N O : Not located.
PHYTOTOXICITY TO TARGET WEEDS : None.
PHYTOTOXICITY TO OPS : None.
MODE OF ACTION : Used to delay thS nitrification of ainmoz iacal and urea
nitrogen fertilizer compositions in the soil by controlling the nitrifi
cation process.
5 N—Serve
2—chloro-4—( trichloromethyl)pyridine
Issued: 7—27—84 I-069203’ l
—13—
-------
EPA Index to Pesticide Chemicals
NITRAPYRIN
Site, Dosage Tolerance, Use, Limitations
and Formulation
tib a.i./A)
AGRICULTURAL CROPS
General Warnings and Limitations : Incorporate nitrapyrin to a depth of 2
to 4 inches. Make only 1 application per year.
Corn 1.0 ppm (forage and fodder)
0.1 ppm (grain)
0.1 ppm (fresh corn (including sweet (kernel plus
cob with husk resoved)))
0.23—0.3 Preplaut or at planting, row or band application.
(2 lb/gal EC) Use higher rates with ill fall applications and
(2 lb/gal SC/L) most spring applications.
0.5—1 Preplant or at planting broadcasc application.
(2 lb/ga). EC) Use the higher rate when fall applications are
made on spring planted crops. May be tank mixed
with EPTC, butylate, atrazine, alachior, cyana—
sine, metolach.1or, or combinations of butylate
with atrazine or cyanazine.
0.5—1 Prepi.aut or at planting broadcast application.
(2 lb/gal SC/L) Use the higher rate when faU applications are
made for spring planted crops.
0.5—1 Preplant application with liquid inimal mstes in
(2 lb/gal EC) the fali. or spring. Use the higher rates for aU
fall applications with an 4 1 stes.
0.25—0.5 Po.tplant row or band application. Us. up to 30
(2 lb/gal EC) days after planting.
(2 lb/gal SC/L)
Cotton 1.0 ppm (cottonseed)
0.25—0.3 Preplant or at planting band app. ication. Use
(2 lb/gal EC) higher rats when applied in the fall to spring
planted cotton.
0.23—0.5 Preplant or at planting broadcaa . application.
(2 lb/gal EC) Use higher rate when applied in the fall to spring
planted cotton. May be tank mixed with triflura—
un, proflural or pendiaethalin.
Issued: 7—27—84 I—0692032
-14-
-------
“p. Iz. :z o Pesticide Chemicals
NITRAPYRIN
Site, Dosage Tnter3nce. Use, Limitations
and Formulation
(lb a.i./L)
Cotton (continued)
0.23—0.3 Preplant or at planting broedcast application.
(2 lb/gal SC/L) Yae higher rate when applied in the fail to spring
planted cotton.
0.25 Postplant row or band app. ication. Use up to 45
(2 lb/gal ZC) days after planting.
(2 lb/gal SC/L)
Lice 0.2 pp. (graIn)
2.0 pp. (straw)
0.3—1 Preplsut or at planting application. Lice fields
(2 lb/gal EC) should be flooded with.i.n 30 days of seeding and
(2 lb/gal SC/L) th. flood should be asintained throughout the
growing season. Irrigation ter fro. treated
rice fields can only be used on corn, cotton, sor—
:‘ h,at. Nay be tank aired with .olh ..ts.
So rgh 0.5 pp. (fodder)
0.1 pp. (grain and forage)
0.25-0.3 Preplant or at planting baud or row application.
(2 lb/gal EC) Use higher rat. with f.3 1 and .bat spring appli—
(2 lb/gal SC/L) cation..
0.5—1 Preylaiit or at planting broadcast application.
(2 lb/gal EC) Us. the higher rat. when fall applications are
m .d. for spring planted crops. Nay be tank aired
with atrazine or cy .n.zln..
0.5—1 Preplant or at planting broadcast application.
(2 lb/gal SC/L) Use th. higher rat. when fall applications ax.
asda for spring planted crops.
‘0.3—1 Prepleat application with liquid .uim.1 m.stss in
(2 lb/gal EC) th, fall or spring. Use th. higher rates for all
fall applications with . ii4 a1
Strawberries .2 pm (strawberries)
0.5 U.. I 4 4 ted to C*1(fornia. Prepisut application.
(2 lb/gal IC, SCL) Plant strawberrie. as soon as practical there-
after.
Issued: 7—27-14 I-0b9203-3
—15—
-------
EPA Index to Pesticide Chemicals
NITRAPYR1N
Site, Dosage Tolerance, Use, Limitations
and Formulation
(lb a.i./A)
Wheat 0.1 ppm (grain)
0.5 ppm (forage and fodder)
0.25—0.5 Preplant or at planting band or row application.
(2 lb/gal IC) Use the higher rate with all Lal]. and most spring
(2 lb/gal SC/L) applications.
0.3—]. Preplant or at planting broadcast application.
(2 lb/gal EC) Use the higher .ates when fail applications are
(2 lb/gal SC/L) made for spring planted crops.
0.3—1 Preplant application with liquid animal wastes in
(2 lb/gal IC) spring or fall. Is. the higher rate for all fail
applications with an iaa1 wastes.
Issued: 7—27-84 1-069203-4
-16-
-------
EPA Index to Pesticide Chemicals
NITRAPYRIN
Listing of Registered Pesticide Products by Formulation
90% technical concentrate
nitrapyrin (069203)
000464—00434
2 lb/gal emulsifiable concentrate
nitrapyrin (069203)
000464—00432
2 lb/gal soluble concentrate
nitrapyrin (069203)
000464-00433
State Label Registrations
AZ keg. No.
000464—06843 000464—06845
CA keg. No.
000464—06842 000464—06844
Issued: 7—27—84 1—069203—5
-17--
-------
EPA Index to Pesticide Chemicals
NITR.APYRIN
Appendix A
Listing of Common Chemical Na ea Used on the Entry
Chemical Common Name EPA Acceptable
Code — (source) Common/Chemical Name
041401 EPTC S—ethyl—N,N—dipropylthiocarbamate
041402 Molinat e S—ethyl hexahydro—i.B—azepine—l—carbo—
thio.te
041403 Butylate S—ethyl diisobutylthiocarbamate
Issued: 7—27—84 I.0692034
-ig-
-------
EPA Index to Pesticide Cheii icai.s
NI’rRAPYRIN
Appendix 3
Listing of Registration Nuabers By Site
Corn
000464—00432 000464—00433 000464—06842 000464—06843
000464—06844 000464-06843
Cot ton
000464—00432 000464—00433 000464—06842 000464—06843
000464—06844 000464—06845
Rice
000464—00432 000464—00433
000464—00432 000464—00433 000464—06842 000464—06843
000464—06844 000464—06845
Strawberries
000464—00432 000464—00433
Wheat
000464—00432 000464—00433 000464—06842 000464—06843
000464—06844 000464—06845
Issued: 7—27—84 1—069203—i
-19-
-------
EPA Index to Pesticide Chemicals
NITR.APYRIN
C0)e 1F NTS
Listing of Registered 24—C Pesticide Products
State Number Federal Registration Number
AE.79002 100 000464 —00432
AR790024 0 0 000464—00433
AR82000300 000464—00432
£R8 2000400 000464—0043.3
K Y? 9000600 000464—00433
LA79002 100 000464—00433
Listing of Registered 24—C Pesticide Products By Sit.
Corn
1CY7 9000600 000464—00433
Cotton
AR79002 100 000464—00432
A&79002400 000464—00433
LA79002 100 000464—00433
Rice
A&82000300 000464—00432
R82000400 000464—00433
-20.-
-------
‘ ‘. to Pisticide Che ic*ls
NITRAPYRIN
CO?O NTS
Products Co tsining Nitrapyrin
Product
Act iv . j t Foreulation Mane Manufacturer
464—432 Nitrapyrin 24.32 EC N—Serve 24! Dow Chemical Co.
464—433 Nitrapyrin 24.72 SC/L N—Serve 24 Dow Chemical Co.
464-434 Nitrapyrin 902 T.ch N-Serve TG Dow Chemical Co.
464-6842 Nitrapyrin 24.32 EC N—Serve 24! Dow Chemical. Co.
(CA only)
464-6843 Nitrapyrin 24.32 EC N—Serve 24! Dow Chemical. Co.
(AZ only)
464—6844 Nitrapyrin 24.72 SCIL N—Serve 24 Dow Chemical Co.
(CA only)
4644845 :4.72 SC/L N—Sir,. 24 Dow Chemical Co.
(AZ only)
*179002100 Nitrapyr n 24.32 IC N-Serve 241 Dow C i c&l Co.
(AZ only)
*179002400 Nitrapyr n 24.72 SC/L N-Serve 24 Dow 1Th eel Co.
(AZ only)
A182000300 Nitrapyrin 24.32 ZC N-Serve 242 Dow Chemical. Co.
(AZ only)
1122000400 Nitrapyr n 24.72 SC/L N-Serve 24 Dow Chemical Co.
(AZ only)
1T79000600 Nitrapyrin 24.72 SC/L N-Serve 24 Dow Chical Co.
(IT only)
LA9002100 Nitrapyrmn 24.72 SC/L N—Serve 24 Dow Chemical Co.
(LA only)
—21—
-------
EPA Index to Pesticide aisaicals
NITRAPYLIN
Listing of Product, Coos and Chemical Names
Che. Product Coe.on Chemical N.. . Manufacturer
Code N. .. N a n.
080803 Atragia. 2—chloro-4-.thylamino-6—isopropylaain.—l ,3,5— Shell Chemical Co.
triasins
100101 Mad.x Cyanazine 2( (4—chloro-6—(.thylaaino)—a—triaz in.—2-yl )a .ino)— Shell Chemical Co.
2—..thylpropionitril.
041401 Eradroan. QTC + S—.thyl-MN—dipropylthiocarba.at. plus n ,u-disllyl— Stauffer Chemical Co
8 -25788 l,l—dichloroac.ta.id. (inert safener)
090501 Lasso Alachior 2—chloro—2’ ,6 —di.thyl—N—(m.thoxy .ethyl)—acetani— Monsanto Co.
lids
108801 Dual Netolachior 2-chloro—N—( 2—.thyl-6— ..thylph.nyl)—N—( 2-aethoxy— CIBA-Giegy Corp.
1-a.thylethyl )sc.ta.id.
041402 Ordr.. Nolinat. S—ethyl huahydro—lN-.z.pin.—1—carbothioat. Stauff.r Chemical Co.
100501 Prowl P.ndl..thslin N—(l—.thylpropyl )—3, 4—di..thyl—2 ,6—dini trobensan— A..rican Cyanamid Co.
amid.
041405 Sutan+ Rutylat. + S—ethyl diisobutylthiocarbamat. plus N—N-diallyl— Stauffer Chemical Co.
ft—23788 1, l—dichloroac.tamide (inert saf.o.r)
106601 TOlbsm Profluralin II—(cyclopropyl.etbyl )—a a ,a—tri tluoro—2 ,6-dinitro— C 18A-Ceigy Corp.
$—propyl—p-tolutdia.
036101 Trsflsa Trifisaralin a,., a—trifluoro—2 ,6—dimitro—N, N—dipropyl—p—toluidine Elanco Products Co.
069203 lI-Serve )litrapyrin 2—chloro-6—(trichloro.ethyl)pyridin. Dow Chemical Co.
-22-
-------
RE UIRE 4ENT R)R SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIF1 A sec. 3(c) (2) (B). The
tables following this section list the data required for
maintaining the registrability of each product.
EPA has determined that additional generic data described
In Table A must be suthiitted to EPA for evaluation in order
to maintain In effect the registration(s) of your product(s)
identified as an attachment to the cover letter accanpanying
this guidance document. As required by FIB A sec. 3(c)(2)(B),
you are required to take appropriate steps to ccmply with
this Notice.
EPA may suspend the registration of each of those products
unless, within the specified time, you have informed EPA how
you will satisfy the requirements of this Notice. Any such
suspension will remain in effect until you have canplied with
the terms of this Notice.
B. What Generic DataiL Mu8t be Sut*nitted . You may deter-
mine which generic data you must sut*nit by consulting Table A
at the end of this chapter. That table lists the generic
data needed to eva].uate the continued registrability of all
products, and the dates by which the data must be sutinitted
The required studies must be conducted in accordance with
EPA approved protocols (such as those contained in the Pesticide
Assessment Guidelines .2/ or data collected under the approved
protocols of the Organization for EconcLnic Cooperation and
Developnent (OEX D). If you do not wish to develop data
in support of certain uses appearing in your labeling, you
may delete those uses at the time you sutinit your revised
labeling.
For certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a “typical
formulation,” and in those cases EPA needs data of that type
.!/ Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient, regardless
of the product’s unique composition or specific use. Product—
specific data relate only to the properties or effects of a
product with a particular composition (or a group of products
with closely similar composition).
.2. ’ The Pesticide Assessment Guidelines are available In hard
copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va. 22161.
—23—
-------
for each major formulation category (e.g., emulsifiable concen-
trates, wettable powders, granulars, etc.) These are classified
as generic data ar when needed are specified in Table A.
EPA m&y possess data on certain “typical formulations” but
not others. Note : “Typical formulation” data should not be
confused with product-specific data (Table B) which are
required on each formulaticxi. Product-specific data are
further explained In Chapter III of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
suthiit to EPA a completed copy of the form entitled “FIFRA
Section 3(c)(2)(B) SulTlnary ieet ” [ EPA Form 8580-1, Appendix
11—3] for each of your products. On that form you must state
which of the following methods you will use to comply with
the requirements of this Notice:
1. (a) Notify EPA that you will 3u1*Tlit the data, and
(b) either sulxnlt the existing data you believe will
satisfy the requirement, or state that you will generate
the data by conducting testing. If the test procedures
you will use deviate from (or are not specified in) the
Pesticide Assessment Guidelines or protocols contained in
the Reports of Expert Groups to the Chemicals Group,
Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Progranne, you must enclose the
protocols you will use.
OR
2. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly develop (or
share in the cost of developing) the data. If you elect
this option, you must notify EPA which registrant(s) are
parties to the agreement.
OR
3. File with EPA a completed “Certification of Attempt to
Enter Into an Agreement With Other Registrants for Develop—
merit of Data” (EPA Form 8580—6, Appendix II_k)*/
*1 FIFRA sec. 3(c)(2)(B) authorizes joint development of
data l y two or’ more registrants, and provides a mechanism by
which purtles can obtain an arbitrator’s decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agrr e to develop data jointly.
(Footnote continued on next page)
—24—
-------
OR
L I. Request that EPA amend your registration by deleting
the uses for which the data are needed. (This option is
not available to applicants for new products.)
OR
5. Request voluntary cancellation of’ the registration(s)
of’ your products for which the data are needed. (This option
is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required data
or how quickly the data must be submitted. If the test
procedures you plan to use deviate from (or are not specified
in) the registration guidelines or protocols contained in
the reports of tha Expert Groups to the Chemical Groups,
Organization for Economic Cooperation arid Development (OECD)
Chemicals Testing Prograrrine, you must submit the protocol
for Agency review prior to the initiation of the test.
If’ you think that you will need more time to generate the
required data than is allowed by EPA’s schedule, you may
submit a request for an extension of’ time. The extension
request must be submitted in writing to the Product Manager.
(Footnote continued from previous page)
In EPA ’s opinion, joint data development by all regis-
trants subject to a data requirement or a cost—sharing agreement
among all such registrants is clearly in the public interest.
Duplication of’ testing could increase costs, tie up testing
facilities, and subj ect an unnecessarily large number of
animals to testing.
As noted earlier, EPA has discretion to suspend the
registration of a product when a registrant falls to submit data
required under FIF A Section 3(c)(2)(B). EPA has concluded that
it & -iould encourage joint testing rather than duplicative
testing, and that suspension should he withheld in certain cases.
to further this goal. Accordingly, if (1) a registrant has
lnf’orrned us of his intent to develop and submit data required
by this Notice; and (2) a second registrant infonns EPA that
it has mede a bona fide offer to the first registrant to share
in the expenses of the testing [ on tenms to be agreed upon
or deter nined by arbitration under FII ’RA Section 3(c)(2)(B)(iii)];
and (3) the rirst registrant has declined to agree to enter
tnt-) a cost—sharing agreement, EP will riot suspend the
second ftr n ’s registration.
—25—
-------
The extension request should state the reasons why you believe
that an extension is appropriate. While EPA considers your
request, you must strive to meet the deadline for submitting
the required data.
—26—
-------
TABLE A
GF RIC DATA I QUIR 74 N S FOR Nrfl APYRIN
Data Must Be
Guideline Citation and
Name of ¶L at
Teat
Substancei/
Guidelines
3tatu& /
Are Data
Required
Yes No
Footnote
Nuther
Sutznltted Within
Tlineframes Listed
Below?J
l58.12O Product Chemistry
Product Identity and Ca osition :
61—1 - Product Identity and Disclosure
of Ingredients TOAI B El ____________ 6 Months
61—2 - Description or B inning Mate-
rials and Manuracturing Process TGAI E ] _____________ 6 Months
61—3 - .eouasion or F rmation of
Impurities TOM B [ X ] El _____________
— 6Mcxiths
Analysis and Certification of Product
Ingredients
62—1 - Preliminary Analysis of Product
Samples TGAI CR [ !] [ ] ____________ 12 Months
Physical and Chemical Characteristics
63-2 - Color T OAI B [ Xl [ ] _____________ 6 Months
63-3 - Physical State TOAI R [ X l El _____________ 6 Months
63—Ji - Odor TOM B [ X l [ ] _____________ 6 Months
63-5 - Melting Point TOM B L X ) El ____________ 6 Months
63-6 - Boiling Point N/A J R El LX] ____________
63—7 — Density, salk Density, or
Specific Gravity TOM R [ ] C] _____________ 6 Months
—27—
-------
TABLE A
c uc DATA r QUIR 11’S FQ NTfl APYRIN
Guideline Citation arxl
Name of ¶Ièst
Teat
Substance!!
Guidelines
StatuaY
Are Data
Required
Yes No
Footnote
Ntmter
1 ta t4&st
Submitted
Timeframes
Be1ow. /
Be
Within
Listed
§158.120 Product Chemistry (continued)
63-8 — Solubi lity
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63—11 — Octanol/Water Partition
Coefficient
63-12 - pH
63-13 — Stabilit ,
Other Requirer nt:
TGAI or PA l
PAl
PAl
PAl
TGAI
TGAI
R
R
R
R
R
R
[ !] [ ]
I X ] fl
[ J IT]
f ] fl
[ Y] IT]
[ Y) [ ]
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 s-1 — Suhni ttal of’ samples
N/A
(
IT] I X]
1/ Ccinpoaiticn: IOPJ = technical grade of the active ingredient; PAl = pure active Ingredient.
2/ Data must be submitted within the Ir iicated tlmeframe, based on the date of the Guidance Document.
— ° 6 Month Dus Date I a December 31 1985 .
° 12 Wmth Doe Date is June 30, 19 6 .
3/ Not required because the 90% technical is a solid at roan temperature.
k/ R - Required; CR = Conditior3ally required
—28—
-------
TAB lE A
GENERIC DATA REQUIREMENI’S FOR NITRAPYRIN
Data Requirement
Cctnposition /
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially )
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Tirnefraxne for Data
Submiss ion L .
§158.125 Residue Chemistry
171 —14 — Nature of Residue (Metabolism)
171 -14 - Residue Analytical Method
PAIRA and plant
metabolites
00110311
00116907
00037878
00037873
00088727
00037876
00037870
00037872
00037875
00038 1 180
00116901
00116902
00116919
00088737
000140049
00110311 !
00039625
00037886
00037887
00052961!
0001100116
001091157
00037881
00039620
000523143
000396211
—
Plants
PAIRA Partially
-
Livestock
Partially
— Plant residues
Ye / 21! Months
Yea / 18 Months
Ye / 24 Months
AI and plant
metabolites
—29—
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NIThAPYRIN
Data Requirement
S158.125 Residue Chemistry
(oontiriied)
Canpos1tion /
Does EPA Have Data
¶Ib Satisfy This
Requirement? (Yes,
No 1 or Partially)
Bibliographic
Citation
Must Additional Data
Be Suthdtted Under
PIFRA § 3(c)(2)(B)?
Tlmeframes For Data
Sutinission?/
— Crop Group # 1 - Cereal Grains
° Crop # 1 Corn (Grain and Sweet)
00037886
00037885
00037888
00037882
000 1 4001 19
000110054
00076728
000523143
000140056
000140057
00039619
00110311
G 5021300 1
GS0213002
— Crop field trials
— Processed Food/FeediW
TEP
EP
Partially
00110318
000400148
00040050
Ye8Z / 24 Months
AI and metabolites
PA l
- Animal residues
171—4 - Storage Stability Data
171—4 — Magnitude of tl Residue—
(Residue Studies for Each
Food Use)
Partially
Partially
Ye / 18 Months
Yea ./
24 Months
-30-
-------
TABLE A
GE Jfl IC DATA REQUIR 4EW2S FOR NflT APYRIN
Must
Does EPA Have Data
Be Suthdtted Under
Data
Requirement
Canpos1tior i/
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
FJ1 A § 3(c)(2)(B)?
Timefrarnes For Data
Sut*nissior /
§158.125 Residue Chemistry
( contirued)
o Crop #2 — Rice (Grain)
— Crop Field Trials TEP Yes 00052963 No.W 21 McntJ is
— Processed Food/Feed EP Yes 00052963 Nc&/ 2i Months
o Crop #3 - Sorghum (Grain)
— Crop Field Trials ¶IEP Partially 00039619 Ye 2 / 2 4 Mcnthz
— Processed Food/Feed 2W EP
o Crop #k - Wheat (Grain)
— Crop Field Trials ‘ IEP Partially 00037881 YeslOa,C/ 214 Mcnths
00039620
— Processed Food/Feed iP / EP
- Crop Group #2 - Forage, Fodder and
Straw of Cereal Grains
o Crop #1 - Corn Forage and
Fodder
— Crop Field Trials ¶IEP Partially 0001400146 Yes!V 214 M(xlths
0001 100148
000110050
00110318
o Crop #2 - Rice Straw
— Crop Field Trials ‘ IEP Yes 00052963 No / 214 Mcutha
—31—
-------
TABLE A
GENERIC DATA REQUIRENENTS FOR NITRAPYRIN
Data Requirement
Cariposition ./
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Tiineframes For Data
Submission?!
§158.125 Residue Chemistry
(contirued)
Crop #3 - Sorghum Forage
and Fodder
— Crop Field Trials
TEP
Partially
00039619
0oo)4o0 I6
Yes! / 214 Months
— Processed Food/Feed
° Crop #14 - Wheat Forage
and Straw
EP No
— Crop Field Trials
TEP
Partially
00037881
000400146
00039620
esi / 2 4 Months
- Crop Group #3 - F n 1l Fruits
and Berries
° Crop — Strawberries
— Crop Field Trials
TEP
Partially
000523141
00052343
Yes / 2 4 Months
— Miscellaneous Crops
° Crop - Cottonseed
— Crop Field Trials
Partially
00088737
001103114
yes.i / 21 ! Months
— Processed Food/Feed
EP
Partially
000140053
24 Months
Ye / 214 Months
—32—
-------
TABLE A
GENF2UC DATA REQUIRE TS FOR NITRAPYRIN
Must Additional Data
Does EPA Have Data Be Sutinitted Under
Th Satisfy This FIF A § 3(c)(2)(B)?
Data Requirement Canpositioni/ Requirement? (Yes, Bibliographic Timeframes For Data
No, or Partially) Citation ut:inissior&i_______
§158.125 Re8idUe C1 nistry
(contirued)
— Meat/Poultry ¶IUAI or plant Partiaiiy.UW 000140054 N&i / 18 Months
metabolites 00040055
000140056
0001 10057
1/ Canposition: ‘IOAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radlolabelled; TEP =
Typical end-use product; EF = End-use product.
2/ Data must be sutinitted within the indicated tlineframe, based on the date of the Guidance Document.
o 18 Month Due Date is December 3]. 1986 .
o 24 Month I).ie Date 18 June 30, 19 7 .
3/ AdditIonal Data Required: Corn and two other representative crops such as potatoes and soybeans must be grown to
maturity In soil treated at—planting with ring—labeled [ 14 C] nitrapyrin. Definitive techniques such as GC/MS must
be used to characterize residues following exhaustive extraction procedures which Include hydrolytic steps. A wide
variety of potential metabolites must be sought such as C0 2 , oxidative intermediates, and dechlorinated and
decarboxylated residues as well as related pyridine impurities in the technical.
14/ Additional Data Required: Poultry and ruminants must be fed both ring-labeled ( 14 C) nitrapyrin and ring-labeled
( 14 C) 6—chloroplcolinic acid (6—CPA) metabolite in separate tests for at least 3 days. The distribution and nature
of residues must be determined within 211 hours of dosing cessation in at least muscle, liver, kidney, and fat.
Additionally, milk and eggs must be collected twice daily for analysis. If ruminant and/or poultry metabolism differ
fran that in rats (not adequately defined to our knowledge), then we will also require swine metabolism studies.
5/ Additional Data Required: One or more methods must be developed which determine 6-CPA, nitrapyrin se, and any
additional residues of concern based on the requested plant and animal metabolism studies. Representative crops
bearing “weathered” residues and animal tissues must be extracted using one or more solvent systems and then
sequentially hydrolyzed using acid, base, and enzymatic systems (glycosidases, lIpas s, proteases). Recoveries of
all residues of concern must be determined after each step. It is preferred that [ 1 C] nitrapyrin be used for
treathients (this could be incorporated into the plant and animal metabolism studies). Samples must contain detect-
able residues at or above the tolerance level.
—33—
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TABLE A
GENFRIC DATA QUIRF 4EW1 S FOR NITRAPYRIN
5158.125 Residue Chemistry (continued)
6/ Additional Data Required: Storage stability of nitrapyrin se in or on corn grain, forage, fodder, fresh corn
aid in animal tissues, milk, and eggs. Storage stability ofiany additional residues of concern In or on representa-
tive plant and animal cannodities it metabolism studies reveal new metabolites of concern. To validate the currently
available data on wheat grain and straw, stability data are required reflecting storage at roan tsmperature for the
duration used in the residue te8ts.
/ Additional Data Required: a) Separate tests reflecting at—plant applications of the 2 lb/gal EXJ or SOIL at 1 lb
at/A ard postplsnt applications at 0.5 lb al/A (made 30 days postplant) mu8t be conducted on sweet corn In FL, IL,
MN, NY, OR or WA, and WI and must be conducted on field corn in representative states such as IA, IN, MN, and NE.
Residues of the parent canpouid and 6-CPA, tree and tissue—bound, must be determined as well as any new residues
of concern as determined fran the requested plant metabolism studies. b) If residues are detected, then processing
studies must be conducted to determine residues In milling products, crude and refined oil, and cannery waste.
8/ No residue data on rice required at this time, including processed products. However data may be required in the
future pending the outcane of requested plant metabolism, storage stability, and metbodolcgy studies.
9/ Additional Data Required: a) Sorghum grain must be analyzed for residues of nitrapyrin, 6-CPA (bound and free), and
any additional residues of concern. Sorghum grown In KS, NE, and TX must be treated at-plant with the 2 lb/gal
or SOIL formulation at 1 lb al/A (broadcast and soil-incorporated). b) If residues occur in grain, then a
fractionation study would be required (if not translated fran wheat).
10/ Additional Data Required: a) Wheat grown in CA, IL, KS, ND, TX and WA must be treated with the 2 lb/gal FC or SO/L
fonnulatinn of nitrapyrin at—plant (broadcast and soil-incorporated). Mature grain must be harvested and analyzed
for reaid s of nitrapyrin se, 6—CPA (free and tissue—bound), and any additional residues of concern as
identified in the requested I PiE metabolism data. b) If residues of concern are detected In grain, a fractionation
study will be required. c) To validte the currently available data, storage stability data reflecting roan
tes erature ator ge of grain for appropriate duration must be sutmnitted as weU.
11/ Additional Data Required: Separate tests reflecting at-plant application of the 2 lb/gal EX or SO/L at 1 lb al/A
and postplant applications at 0.5 lb al/A (made 30 days postplant) must be conducted in IA, MN, NE, PA, and WI.
Residues of nitrapyrin and 6—CPA (tree aid tissue-bound) in or on corn forage and fodder as well as any additional
residues of ooncer , Identified in the requested plant metabolism studies are to be determined.
12/ No residue data are required on rice straw at this time. However data may be required in the future depending
upon the outcane of the requested plant metabolism, storage stability, aid methodolc y studies.
—34—
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TABlE A
GENERIC DATA REQUIREMENTS FOR NITRAPYRIN
§158.125 Residue Chemistry (continued)
13/ Additional Data Required: a) Sorghum forage, fodder, and hay must be analyzed for residues of nitrapyrin se,
6—CPA (bound and free), and any additional residues of concern. Sorghum grown in GA, KS, and SD must be treated
at-plant with the 2 lb/gal FX or SC/L formulation at 1 lb ai/A (broadcast and soil—incorporated). b) A processing
study should be conducted to determine the above residues in sorghum syrup.
1IV Additional Data Required: Wheat grown in CA, IL, KS, ND, TX, and WA must be treated with the 2 lb/gal EC or SC/L
formulation of nitrapyrin at—plant (broadcast and soil—incorporated). Forage and straw must be harvested and analyzed
for residues of nitrapyrin 6—CPA (free and tissue—bound), and any additional residues of concern as identified
In the requested plant metabolism data. To validate the currently available data, storage stability data reflecting
room storage of grain for appropriate duration must be submitted as well.
15/ Additional Data Required: Studies must be conducted in strawberry growing areas of Monterey and Ventura counties in
CA. ‘The 2 lb/gal E C or SC/L must be soil—incorporated at 0.5 lb al/A within a few days preplant. Nitrapyrin, 6—CPA,
and any additional residues of concern must be determined.
16/ AdditIonal Data Required: a) In separate tests conducted in AZ, CA, MS, and TX, at—plant and postplant applications
of the 2 lb/gal or SC/L must be made at 0.5 and 0.25 lb al/A, respectively. A single annual, soil—incorporated
treatm it must be made at each site. Mature cottonseed and forage must be analyzed for residues of nitrapyrin per
se, 6—CPA (free and tissue—bound), and any additional residues of concern identified in the requested plant metab-
olism studies. b) Additional data may be required on processed products of cottonseed pending results of the
requested residue data, plant metabolism data, storage stability data, and revised analytical methods, if necessary.
17/ a) The nunter of milk samples (OOO 4 OO 5 6) and the intervals between swine and poultry dosage cessation and slaughter
— must be specified. b) No additional livestock feeding studies are required at this time. However, additional data
may be re 4 uired in the future depending on the outcome of the requested plant and animal metabolism studies, storage
stability data, and revised methodology (if ’ necessary). Note that nitrapyrin se, and perhaps metabolites other
than 6—CPA, may need to be administered and determined in the future.
—35—
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TABLE A
GENERIC DATA REQUIR v1EwrS FOR N fl APYRIN
Must Additional Data
Does EPA Have Data
Be Suth iitted Under
Data
Requirement
Ccxnpositiorii/
Use
Patterns. /
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
FIFRA § 3(c)(2)(B)?
Timeframes For Data
SulTnission J
§158.130 &wironnenta]. Fate
DEX ADATION S I’UDIES-LAB :
161—1 — Hydrolysis ¶ AI or PAIRA A,C No Yes 9 Months
Photodegradat ion
161-2 — In Water JAI or PAIRA A,C No Yes 9 Months
161—3 — c Soil ! AI or PAIRA N/A N/A No!!!
161 —1 — In Air ¶LUAI or PAIRA N/A N/A
M B0LISM S IFS-LAB :
162—1 — Aerobic Soil ¶1 AI or PAIRA A Yes 00117010 No
162—2 — Anaerobic Soil ‘1t A1 or PAIRA A Yes 00117998
162—3 — Anaerobic Aquatic WAI or PAIRA C Yes 00117998 No
162—it — Aerobic A at1c 1 AI or PAIRA C No Yes 27 Months
)BflJIT! S’IUDIES :
163—1 — Leaching and ¶I )AI or PAIRA A,C PartIally 00079381 Yesl/ 12 Months
Adsorption!
Desorption
163—2 — Volatility (Leb) IEP N/A N/A O011029 &I No .I
163—3 — Volatility (Field) ‘IEP N/A N/A
—36—
-------
TABlE A
GENBRIC DATA REQUIRE}IENTS FOR NTfl APYRIN
Data Requirement
Caupos1t1on /
Use
Patterns?.!
Does EPA Have Data
To Satisfy This
Requir nent? (Yes, Bibliographic
No, or Partially) Citation
Must AdditionaL Data
Be Sutinitted Under
FIB A § 3(c)(2)(B)?
Tlmeframes For Data
Sutznission /
§158 . 130 &ivirorinental Fate
(continued)
DISSIPATION S’IUDIFS-FIELD :
164-i — Soil
164—2
164—3 — Forestry
164—4 — Canbiriation and
Tank Mixes
16 1 1—5 — Soil, erm
ACCUMULATION ‘1UDIES :
165—1 — Rotational Crops
(Confined)
165-2 — Rotational Crops
(Field)
- Irrigated Crops
- In Fish
165—3
165—4
165-5 - In Ac atic Non—
Thrget Organisms
Subpart K Re-entry
1/ Ccinposition: ‘IWJ — Tachnical grade of the active ingredient;
typical end-use product.
PAIRA = Pure active ingredient, radiolahelled, ‘IEP =
— Aquatic (Sediment)
A
No
Yes
27Mcxiths
‘ IEP
C
No
Yes
27
Months
‘ lEP
N/A
N/A
No!!
N/A
N/A
No . 12 .!
‘IEP
A
N/A
NQIV
PAIRA
A
No
Yes .i .
39
Months
‘IEP
A
No
Yesi /
50
Months
IIEP
A
No
Yes . 1 /
39
Months
TGAI or PAIRA
A,C
Yes
00101635
No
¶IEP
N/A
N/A
No.W
N/A
N/A
No /
—37—
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TABLE A
GENF IC DATA REQIJIRE €NTS FOR NTTRAPYRIN
§158.130 B viror nental Fate (continued)
2/ Tbe use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non—Food; C = Aquatic, Food Crop;
D = Aquatic, Non—Food; E = Greenhouse, Food Crop; F = Greenhouse, Non—Food; G = Forestry; N = Domestic Outdoor;
I = Indoor.
3/ Data must be submitted within the indicated tiinefrarne, based on the date of the Guidance Document.
o 9 Month Due Date is March 31, 1986 .
o 12 Month Due Date is June 30, 19 36 .
o 27 Month Due Date is September 30, 1987 .
o Month Due Date is September 30, 19 3ö .
o 50 Month Due Date is August 31, 19 39 .
I V No data are required since nitrapyrin is soil injected or incorporated upon application.
5/ Exposure is not expected to be significant since all currently registered uses of nitrapyrin require soil Injection
or incorporation during or 1i nedIately after application; and since nitrapyrin has been tentatively classified in
Toxicity Category III on the basis of acute oral and dermal toxicity studies.
6/ Acceptable data t’or anaerobic aquatic metabolism 162—3 will also satisfy the requirement for anaerobic soil
metabolism 162—2.
7/ Data on the adsorption of 6—chioropicolinic acid (a degradate of nitrapyrin) to a loam soil are acceptable. All
other data are required.
8/ This study would be acceptable, however, it is not required to support current use patterns of nitrapyrin.
9/ No data are required since nitrapyrin is not regisitered for forestry use.
10/ Data requirements for combination products and tank mixes are not being imposed for this Standard.
11/ No data are required since results of a valid aerobic soil metabolism study demonstrate that greater than 50%
of residues dissipate prior to recc*iinended subsequent application.
12/ Data are required to determine: a) the nature and amount of pesticide residue uptake in rotational crops,
b) a realistic crop rotation restriction (time from application to a time when crops can be rotated), and
c) to determine if tolerances are needed in rotational crops.
13/ Data are required to determine: a) residue uptake and levels in crops which are expected to be irrigated with
water from a rice field treated with nitrapyrin, b) a realistic label restriction to prevent illegal residues
in irrigated crops, and/or c) whether tolerances may be needed in the irrigated crop.
14/ No data are required for terrestrial or aquatic food crop use patterns.
—38—
-------
TABLE A
GF IC DATA REQUIR Z4EWPS FOR NTI’RAPYRIN
Must Additional Data
Does EPA Have Data
Be Suthiitted Under
Data
Requirement
Canpositioni!
Use
Patterna ./
To Satisfy Ibis
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
FIFRA S 3(c)(2)(B)?
Timefrarnes For Data
Submission /
S158.135 Toxicology
AC 7PE TEST]] :
81—1 — Acute Oral Toxicity TOAI A Yes 00037519 No
81—2 — Acute Dermal Toxicity — TOAI A No Yes 9 Months
Rabbit
81—3 - Acute Inhalation Toxicity - TOAI A No Yes 9 Months
Rat
81—a — Primary Eye Irritation— T OAI A No Yes 9 Months
Rabbit
81—5 — Primary Dermal Irritation— TOAI A Yes 00037522 No
Rabbit
81-6 - Dermal Sensitization T OAI A No Yes 9 Months
81-7 - Acute Delayed N/A V No
Neurotoxicity — Hen
SUBCHRONIC TESTING :
82—1 — 90-Day Feeding:
- Rodent (Rat), and TOAI A No
Non-rodent (D ) TOAI A No No. /
82—2 — 21—Dey Dennal N/AL! No
82-3 - 90-Dey Dennal N/A.W No
—39—
-------
TAB lE A
GB2 BIC DATA REQUIR 4EN S FOR NTfl APYRIN
Must Additional Data
Does EPA Have Data
Be Suttnitted Under
Data
Requirement
Canpositioni/
Use
Patterns. /
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
FIF A § 3(c)(2)(B)?
Tiineframes For Data
Sutinissioni’
§158.135 Toxicology (continued)
82—l i - 90-Day Inhalation - N/A / No
82—5 - 90—t y Neurotoxicity — N/PJ.Q/ No
Hen/Naninal
CHRONIC TEEING :
83—i — Chrcnic Toxicity —
2 species:
- Rodent (Rat-2 yr.) arid TGAI A No Yes 50 Months
- Nai-rodent (Dog-i yr.) ¶ AI A No Yes 50 Months
83—2 — aicogenicity —
2 species:
— Rat (preferred) - 2 yrs., arid TGAI A No Yes 50 Months
— Mouse (preferred) - 18 month ¶LUAI A No Yes 50 Months
83-3 - ratogenicity -
2 species:
— Rat IOAI A No Yes 15 Months
— Rabbit (preferred) ‘IUAI A No Yes 15 Months
83 — I l - Reproduction - TGAI A No YesB! 39 Months
2-generatic i
PIJ AG lICITY ThSTflfl
8 1 1-2 - Gene Matation knee TGAI A No Yes 9 Months
811-2 - Structural Chrcanoscinal TOAI A No Yes 12 Months
Aberration
-------
TABLE A
GENE1 IC DATA REQU 14FR S FOR NITRAPYRIN
Must Additional Data
Does EPA Have Data
Be Submitted Under
Data
Requirement
Cauposition!/
Use
Patterna /
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
FIFRA § 3(c)(2)(B)?
Tiinefraznes For Data
Suttnissiori /
§158.135 Toxicology (continued)
8 14—2 — Other Genotoxic
Effects
DNA Damage & Repair:
thacheduled DNA ‘I AI A Yes 001091456 No
Synthesis
SPECIAL TESTING :
85-1 — General Metabolism
— Rat (perferred) ¶1X AI A No Yes 214 Months
1/ Canposition: Material to be tested is technical grade unless otherwise specified in footnotes (TGAI: technical
grade of the active ingredient).
The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non—Food; C = Aquatic,
2/ Food Crop; 0 = Aquatic, Non—Food; E = Greenhouse, Non—Food; G = Forestry; H = Dc*nestic Outdoor; I = Indoor.
3/ Data must be submitted within the indicated timeframe, based on the date of the Guidance Document.
o 9 Month Due Date is March 31, 1986 .
o 12 Month Due Date is June 30, 1956 .
o 15 Month Due Date is September 30 1986 .
o 2 4 Month Due Date is June 30, 19S .
o 39 Mon th Due Date is September 30, 1988 .
o 50 Month Due Date is August 31, 1989 .
14/ Not applicable since nitrapyrin is not an orgamphasphate.
5/ Not required since 2-year rat chronic feeding study is required.
6/ Not required since 1-year dog chronic feeding study is required.
—41—
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TABLE A
GENERIC DATA REQUIREMENTS FOR NTfl?APYRIN
S158.135 Toxicology (continued)
7/ Not applicable since use of nitrapyrin is not likely to result in repeated human skin contact.
8/ Not applicable since use of nitrapyrin does not Involve purposeful application to the human skin.
9/ Not applicable since nitrapyrin is not expected to result in repeated inhalation exposure at a concentration
likely to be toxic.
10/ Required only when acute delayed neurotoxicity test or acute oral, der al, or Inhalation studies show
neuropathy or rieurotoxlcity. Nitrapyrin is not knDwn to be closely related structurally to a canpourri
which can induce such effects.
11/ A 2—ge ieration reproduction study is required using one species employed in a teratology study.
—42—
-------
TABLE A
GE E IC DATA REQUIRF24 NPS FOR N II APYRIN
Must Additional Data
Does EPA Have DATA Be Suthdttel Under
Use To Satisf’y This Bib11ogra *iic FII’IIA § 3(c)(2)(B)?
Data Requirement Canposition Patterns Requirement? (Yes, Citation Tlmeframes For Data
No, or Partially) S1IhnfRsic J
§158.1140 Reentry Protection
132—1 — Foliar Dissipation N/A N/A N/A No!!
132-1 - Soil Dissipation N/A N/A N/A
133-1 - Dermal Exposure N/A N/A N/A No!!
133 —14 — Inhalation Exposure N/A N/A N/A
11 Not applicable. Data to support establishment of reentry protection standards are not required because the Agency
has deten ined, based on use patterns (soil injection or incorporation during or lninediately after application) for
nitrapyrin, that the criteria in part 158.11 10 are not met.
-------
TABLE A
GENERIC DATA REQUIRE 1ENTS FOR NT RAPYRIN
Must Additional Data
Does EPA Have Data
Be Suthiitted Under
Data
Requirement
canpositiorii(
Use
patterns.a’
To Stalfy This
Requirement? (Yes,
No, or Partially)
Citation
FIFRA § 3(c)(2)(B)?
Timeframes For Data
Submissior /
§158.1k5 Wildlife
arid Aquatic Crganisms
AVIP 1 N AND MAMMAL TESTING
70—1 Special Test Degradation
Product A,C Yes. J 00117016* t’.Jo
71—1 Acute Avian Oral TGAI A,C Yes 00110296* No
Toxicity
71—2 Avian Subacute Dietary ¶1X AI A,C Partially 00116899** Yes 9 Months
Toxicity
71—3 Wild Mamnal Toxicity TGAI A,C No No
71—1 Avian Reproduction ¶I AI A,C No No
71—5 Simulated and Actual
Field Testing -
Maninals and Birds PEP A,C No No
AQUATIC OI ThNISM TESTING
72—1 Freshwater Fish Toxicity
Wannwater mAI A,C Partially 0011029 ’T** Yes 9 Months
Co ldwater ffiAI A,C Partially 00110297 ” Yes 9 Months
PEP C No Reserved. /
72-2 Acute Freshwater
Invertebrates ‘fl AI A,C Partially 00110298 Yes 9 Months
PEP C No ReservedY
-------
TABLE A
GENE UC DATA REQUIRE74E1 I S FOR N TRAPYRIN
Must Additional Data
Does EPA Have Data
Be Submitted Under
Data Requirement
Canpositioni!
Use
Patterns. /
To Satisfy This
Requirement? (Yes,
No, or Partially)
Citation
FIF A § 3(c)(2)(B)?
Tlnieframes For Data
Submiss1ori !
§158.145 Wildlife
and Aquatic Organisme
(continued)
72—3 k ute Toxicity to
Estuarine and Marine
Organisms
— Mollusc
‘IUAI
A,C
No
Yes ,5,7I
12 Months
72—4 Fish Early Life Stage
and Aquatic Invertebrate
Life-Cycle
¶L AI
A,C
No
Reserved!!
72-5 Fish Life-Cycle
‘IUAI
A,C
No
Reserved!!
72-6 Aquatic Organism
¶L AI
A,C
No
Reserved!!
Acctxnulation
72—7 Simulated or Actual
Field Testing —
Reserved!!
Aquatic Organisms
‘ IEP
A,C
No
1/ Canposition: ‘IOAI - Technical Grade of tbe Active Ingredient; ‘IEP - Typical End-use Product.
2/ ‘fl-a use patterns are coded as follows: A, Terrestrial Food Crop; B, Terrestrial Non-Food Crop; C, Aquatic Food Crop;
D, Aquatic Non-Food Crop; E, Greenhouse Food Crop; F, Greenhouse Non-Food Crop; G, Forestry; H, Danestic Outdoor;
I, Indoor.
3/ Data mast be submitted within the indicated timeframe, based on the date of the Guidance Document.
— ° 9 Month Das Date Is March 31, 1986 .
12 ? th Doe Date is June 30, 1986 .
_145_
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TABLE A
GENE UC DATA REQUIRF 4ENTS FOR NTfl APYRIN
S158.1k5 Wildlife and Aquatic Organisms (continued)
14/ Sthdies ma be required pending envirorm tal fate data and additional data on the ¶mAI.
5/ Required for rice use and such crops as cotton and sorghum where 300,000+ acres are grown in coastal counties.
6/ Currently, there is no requirement for degradation products.
7/ Only oyster shell deposition test required.
* Study fulfills data requirement on its own.
** St y must be cited along with additional data to fulfill data requirement.
—46—
-------
III. RQUIHEIVIENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: Unless stated otherwise in Section I, Regulatory
Position arxl Rationale, this Section applies only to manufac-
turing use products, not to end use products.
A necessary first step In determining which statements
must appear on your product’s label Is the completion and
submission to EPA of product—specific data* listed on the
form entitled “Product Specific Data Report” (EPA Form
8580—14, Appendix 11 1—1) to fill gaps identified by EPA
concerning your product. Under the authority of FIM A sec.
3(c)(2)(B), EPA baa determined that you must submit these
data to EPA In order to reregister your product(s). All of
these data must be submitted not later than six months after
you receive this guidance document.
Table B——Product-Specific Data Requirements for Manufacturing
Use Products—lists the product specific data you must submit.
Data that are required to be submitted are identified in the
column of those tables entitled “Must Data By Submitted
Under 3(c)(2)(B). ”
*1 Product specific data pertain to data that support the
formulation which Is marketed; It usually Includes product
chemistry data and acute toxicity data.
—47—
-------
TABLE B
Pr )DUCT SPEEIFIC DATA REQUIRE74FRTS FDR MAMJPACIURIN3-USE PRODUCTS CONTAINING NITRAPYRIN
Data Must
Be
Guideline Citation and
Name of ¶L st
Test
Substancei/
Guidelines
Status?!
Are Data
Required
Yes No
Footnote
Ntirter
Subnitted
Timeframes
Below /
Within
Listed
§158.120 Product Chemistry
Product Identity and Canposition :
61—i — Product Identity and Disclosure
of Ingredients MP R [ X i fl ___________ 6 Months
61—2 — t scription of Beginning Mate-
rials and Manufacturing Process MP LX] iT] ____________ 6 Months
R
61—3 — Discussion of Formation of
Imrurities MP R LX] iT] ___________ 6 Months
Analysis and Certification of Product
Ingredients :
62-i - Preliminary Analysis of Product
Samples MP CR LX] i T] ____________ 12 Months
62-2 - Certification of Ingredient Limits NP {XJ [ TI _____________ 12 Months
62-3 - Analytical Met ds to Verify
Certified Limits MP ft LX] [ TI _____________ 12 Months
Physical and Chemical Characteristics :
63-2 - Color MP R [ X I [ Ti _____________ 6 Months
63-3 - Physical State NP ft [ X l [ T] ____________ 6 Months
63-1t - Odor NP R LX] [ Ti ____________ 6 Months
63—7 — I nsity, Bulk Density, or
Specific Gmvity NP ft [ ] _____________ 6 Months
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MA UFAC 1 flJRflO-USE PRODUCTS CONTAINING NITRAPYRIN
Data Must Be
Guideline Citation and Test Guidelines Are Data Footnote Sulmitted Within
Name of èst Substance!! Status. / Required Number T1 neframes Listed
Yes No Be lowg/
158.120 Product Chemistry (continued)
63-12 - pH MP CR [ ] [ TI ___________ 6 Months
63-l 4 — Oxidizing or Reducing Action MP CR [ Y] [ TI ____________ 6 Months
63-15 — FlairrnabllIty N/A / CR [ Ti [ Y] ____________
63-16 — Explodability MP R [ ] [ Ti ____________ 6 Months
63-17 — Storage Stability MP H [ Yl [ Ti ___________ 15 Months
63—18 — Viscosity N/A. ./ CR [ fl [ ] ____________
63—19 — Miscibility N/A / CR [ J [ ] ____________
Other Requirements :
64-1 - Sutinittal of samples N/A CR [ ] [ Y] ____________
1, Canposition: NP = Manufacturing-use product.
Data must be sutinitted within the indicated time frame, based on the date of the Guidance Document.
o 6 Month Doe Date Is December 31 1985 .
o 12 Month Due Date is June 30, 19 6 .
o 15 Month Due Date is September 30, 1986 .
. ./ Not required because the product is solid at roan temperature.
!!/ R = Required; CR = Conditionally required
rU.S. GOVERNMENT PRINTING OFFICE: 9 85 1+82 597 326 8 3
_149_
-------
111. SUBMISSION OF REVISED LABELING
Note : Thi8 8ection applies to end use products only to the
extent described in Section I (Regulatory Position and
Rationale). Otherwise, the following information perta1
exclusively to manufacturing use products.
FIF A requires each product to be labeled with accurate,
cctnplete and sufficient instructions arid precautions, reflecting
the results of data concerning the product and its ingredients.
Labeling requirements are set out in 14Q CFR 162.10 (see
Appendix IV—1) and are sumnarized for products containing
thi8 active ingredient as part of this Guidance Document
(See Appendix flT-2). Applications submitted in response to
this notice must include draft labeling for Agency review.
If you fall to submit revised labeling infornation
ccinplying with this section (supplemented by requirements
described in Sectim I, Regulatory Position and Rationale),
EPA may issue a notice of intent to cancel the registration
under FIFRA sec. 6(b)(1).
A. Label Contents
A40 CF 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 k ied to Appendix 111-2.
Item 1. PRODUCT NAME — The name, brand or trademark is
required to be located on the front panel, preferably centered
In the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. CCMFANY NAME AND ADDRESS - The name and address
of the registrant or’ distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. cOr11’EN I - 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
Imnediately above the ccinp&iy 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 exprE 88ed In metric units. See Appendix ri-i. [ L o CFR
162.10(d)]
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Item )4• EPA REXIISTRATION NUMBER — The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase “EPA Registratiai No.,” or “EPA
Reg. No.” The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix IV—l.
[ L 0 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NTJTvIBER - 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 irrinedlate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the inmnediate
container cannot be clearly read through such wrapper or container.
See Appendix IV—l. [ 1 0 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 inmnediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished fran, other text on the panel. It must not be
placed in the body of other text • See Appendix IV—l. [ L 0 CFR
162.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. 0NT LABEL PRECAUTIONARY STATE vIENTS - 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
ai 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
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Item TA. CHILD HAZARD WARNING $I’A’IEMEI’ZT - The statement
“Keep Out of Reach of Children” must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. See Appendix IV—l.
[ 40 CER 162.1O(h)(l)(il)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel lirinedlately below
the child hazard warning statement • See Appendix IV-l.
[ 40 CF 162.10 (h)(l)(i)]
Item 7G. SKULL & CROSSBONES AND WORD “POISON” - ( products
assignexi 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 inii ediate proximity to
the word POISON. See Appendix IV—l. [ 40 CFT l62.l0(h)(l)(i)]
Item 7D. $rATFI€ 1 Nr OF PRACTICAL ThEA’I!4E2ff - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix IV—l. [ 40 CER 162.lO(h)(l)(iil)]
Item 7E. RE RRAL STA’IEMENT - The statement “See Side
(or Back) Panel for Additional Precautionary Statements” is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
See Appendix IV—l. [ 40 CFR l62.lO(h)(l)(lii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading “PRECAUTIONARY S’PAIEMENTS.”
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix P1—1. [ 40 CFR 162.10
(h)(2)].
It i 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. See Appendix P1-1. [ 40 CFR 162 .10
(h)(2)(i)]
Item 8B. ENVIRON?v1ENJ AL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix P 1—i. [ 40 GFR
l62.10(h)(2)(ii)]
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Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flaninability statement . Precautionary statements relating
to flaninability of a product are required to appear on the
label If it meets the criteria in Appendix IV—3. The require-
ment is based on the results of the flashpoint determinations
and flame extension tests required to be submitted for all
products. These statements are to be located in the side/back
panel precautionary statements section, preceded by the
heading “Physical/Chemical Hazards.” Note that no signal
word is used in conjunction with the flaninability statements.
2. Criteria for declaration of non—flaniTlability . The
following criteria will be used to determine if a product
is non—flaninable:
a. A “non-flaninable gas” is a gas (or mixture of gases)
that will not ignite when a lighted match is placed
against the open cylinder valve.
b • A “non-flammable liquid” is one having a flashpoint
greater than 350°F (177°C).
c • A “non—flammable aerosol” Is one which meets the
following criteria:
I • ¶L flame extension Is zero inches;
il. There is no flashback; arii
iii. The flashpoint of the non-volatile liquid
ecinponent is greater than 350°F (177°C).
3. DeclaratIon of non—flaninabilIty . Products which
meet the criteria for non—f laninablilty specified
above m&y bear the notation “non-f lamnable” or “ron-
f].amnable (gas, liquid, etc.)” on the label • It may
appear as a substatement to the ingredients statement,
or on a back or side panel, but shall not be highlighted
or em Msized (as with an Inordinately large type
size) in any way that may detract frai’ precaution.
14 • Other hysical/chemica1 hazard statements • When
chemistry data demonstrate hazards of a physical or
chemical nature other than flaninability, appropriate
statements of hazard will be prescribed. Such statements
may address hazards of explosivity, oxidizing or reducing
capability, or mixing with other substances to produce
toxic fumes.
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Item 9A . RES’rRICTED USE CLASSIFICATION - FIB A sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section I
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are sutinitted.
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 res ricted 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 4O CFR 162.11(c). You will be notified of
the Agency’s classification decision.
A. Classification Labeling Requirements
If Section I of this Guidance Document indicates that
your product has been classified for restricted use, the
following label requirements apply:
1. Front panel statement of restricted use classification.
a. The statement “Restricted Use Pesticide” must
appear at the top of the front panel of the label.
The statement must be set in type of the same
minimum size as required for human hazard signal
word (see table in 4O CBR 162.1O(h)(1)(iv)
b. Directly below this statement on the front panel,
a suninary 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.”
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2. Sane but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and sane 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 sut znit 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 , suth it two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be suthiItted simul-
taneously. Note that the products will be assigned
separate registration numbers.
B. Compliance Schedules
No product with a use classified for restricted use
un or this Standard may be released for shipment by the
registrant or producer after one year from the date of
issuance of this Standard, unless such product bears the
restricted use classification. All products still in
channels of trade after two years fran the date of Issuance
of this Standard must be labeled for restricted use.
Item 9B [ There is m Item 9B].
Item 9C. MISUSE STATh)1E2 1P - All products must bear the
misuse statement, “It 18 a violation of Federal law to use
this product In a manner Inconsistent with its labeling.”
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
Item 1OA. I FEWI1 Y STA I 24E iT - 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 lOB [ There 18 ro Item lOB].
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Item bC. S’IORAGE 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 ur der the heading “Storage and Disposal” in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix
IV—1 to determine the disposal instructions appropriate for
your products.
Item 1OD. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix IV—l. [ L 0 CFR 162.10]
B. 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 acccinpany 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.
V. IN PRUCTIONS FOR SUBMISSION
A. For Manufacturing Products (MP) containing Nitrapyrin
as an active ingredient :
1. Within 90 days from receipt of this document, you must
submit to the Product Manager in the Registration Division at
the address given at the end of this section the “FIF A Section
3(c)(2)(B) Suninary Sheet” EPA Form 8580—1. Refer to Appendix
11-3 with appropriate attachments.
If on the Suninary Sheet, you cannit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Suninary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
In response to this notice • This information should be 8Ubmitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual 8tudies are not to be submitted.)
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2. Within 6 months from receipt of this document you must
submit to the Product Manager on the Registration Division:
a. Confidential Statement of Formula, EPA Form 8570—14.
b. Product Specific E ta Report, EPA Form 8580—4
(Appendix 111—1).
c. Two copies of any required product—specific data.
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. The labeling should be either typewritten
text on 8-1/2 x 11 inch paper or a mockup of the labeling
suitable for storage in 8—1/2 x 11 inch files. The draft
label must indicate the intended colors of the final label,
clear indication of the front panel label, and the intended
type sizes of the text.
e. Evidence of compliance with data support requirements
of 1?IFRA sec. 3(c)(1)(D). Refer to 40 CF1 152.80—152.99
(enclosed) for latest requirements.
3. Within the times set forth in Table A , you must submit
to the Registration Division all generic data, unless you are
eligible for the formulator’s exemption. If for any reason any
test is delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
B. 1kw Manufacturing Use Products containing Nitrapyrin
in combination with other active ingredients :
1. Within 90 days from receipt of this docuiient, you must
submit the “FIFRA Section 3(c)(2)(B) Suninary Sheet,” EPA Form
8580—1. Refer to Appendix 11—3 with appropriate attachments.
If on the Suninary Sheet, you comuiit to develop the data,
request a minor chemical exemption, present arguments that a data
requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Surrznary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice • This information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
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2. Within the times set forth in Table A , you must subnit
to the Registration Division all generic data, unless you are
eligible for the formulator’s exemption. If for any reason any
test 18 delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Canplianee
Mcxiitoring.
C. For End Use Products containing Nitrapyrin alone
or in combination with other active Ingredients :
1 • Within 90 days from receipt of this document, you imist
sul nit the “FIFRA Section 3(c)(2)(B) Suninary Sheet,” EPA Form
8580—1. Refer to Appendix 11-3 with appropriate attachments.
If on the Sunmary Sheet, you corrinit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement Is not applicable, or sutinit protocols or modified
protocols for Agency review, you must also sutinit a copy of the
Suninary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
In response to this notice. This information should be sutinitted
to the Office of Compliance Tvbnltoring at the address given at
the end of this section. (Actual studies are not to be sutinitted.)
2 • Within 6 months from receipt of this document you must
sut*nit:
a. Confidential Statement of Fbrmula, EPA Form 8570 -14.
b. Product—Specific Data Report, EPA Form 8580—14
(Appendix i ll—i).
c • Two copies of any required product-specific data.
(Refer to Table C).
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, you may sutinit such labeling. End use
product labeling inunt comply specifically with the instructions
In Section I (Regulatory Position and Rationale) of this
guidance document. Labeling should be either typewritten
text on 8 1/2 x 11 Inch paper or a mockup of the labeling
suitable for storage in 8 1/2 inch files. The draft label
mu8t indicate the intended colors of the final label, clear
indication of the front panel label, and the intended type
sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(l)(D). Refer to 140 CPR 152.80—152.99
(enclosed) for latest requirements.
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3. Within the time frames set forth in Table A , submit all
generic data, unless you are eligible for the formulator’s
exempticri.
D. For intrastate products containing Nitrapyrin either
as the sole active ingredient or in combination with
other active ingredients :
TI se products are being called in for full Federal
registraticri. Producers of these products are being sent
a letter instructing them } w to submit an application for
registraticn.
E. Applications and other required information should be
submitted to the following address:
Richard F. Mountfort
Prcduct Manager 23
Registration Division (TS—767C)
Office of Pesticide Programs
Environmental Protection Agency
1401 M St., SW.
Washington, D.C. 201460
Phor No. (703) 557—1830
The address for submission to the Office of Compliance ?‘bnitoring
is:
Laboratory Data Integrity Program
Office of Compliance Monitoring ( J—3142)
Environmental Protection Agency
1401 M St., SW.
Washington, D.C. 201460
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Appendix 11-1
Guide to Use of This Bibliography
1. a)NTEW.P 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 fran other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a “study.” In the case of published materials,
this corresponds closely to an article. In the case of’
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article Iran 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 carl be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and camnentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by “Master Record Identifier,” or
NRID, 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(dX’4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review my 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
(MEtED), 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.
—60—
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Appendix 11—1 (continued)
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
h. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
fran 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 detennine
or estimate the date of the document.
c. Title. In sane cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears ininediately following the word
“received.”
(2) Administrative Number. The next element,
irrinediately following the word “under,” is the
registration number, experimental use pennit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase “submitted by.” When
authorship is defaulted to the submitter, this
element is omitted.
()4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six—digit accession number follows
the symbol “CDL,” standing for “Company Data
Library.” This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456—A; the second, 123456—
B; the 26th, 123456—Z; and the 27th, l23456—AA.
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OFFICE OF PESTICIDE PROGRAMS Appendix 11-2
RE)GISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Bata Base Supporting
Registrations Under the Nitrapyrin Standard
MRID CITATION
00037519 Norris, J.M.; Plomer, E.; Bourne, J.E.; et al. (1971) Acute Toxico-
logical Properties of Dowco 163. (Unpublished study received
Apr 29, 1972 under 2F1265; submitted by Dow Chemical U.S.A.,
Mldlarxi, Mich.; CDL:092163—J)
0003622 Wolf, M.A. (1963) Results of } man Skin Irritation and Skin Sensi-
tization Studies on N—serve Nutrient Conserver 2—Chloro—6-.
(trichioranethyl) pyridine. (Unpublished study including M-312,
received Apr 29, 1972 under 2F1265; prepared in cooperation with
Hill Top Research Institute, Inc., submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:092163—M)
00037870 Redemann, C.T. (1962) Residues from 2—Chloro—6—(trichlorcznethyl) —
14C—pyridine in Lettuce and in Soil: GS 510. (Unpublished study
received Jun 6, 1973 under 2F1265; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:09216 1 4—D)
00037872 Redemann, C.T. (1962) The F .te of 2—Chloro—6—(trichloromethyl)-.liiC_
pyridine Applied to Cotton under Greenhouse Conditions: GS 516.
(Unpublished study received Jun 6, 1973 under 2F1265; submitted
by Dow Chemical U.S.A., Midland, Mich.; CDL:09216 —F)
00037873 Redemann, C.T. (1961) Metabolism of 2—Chloro—6—trichloromethylpyrj_
dine by the Corn Plant: GS— 65. (Unpublished study received
Jun 6, 1973 under 2F1265; submitted by Dow Chemical U.S.A., Mid-
land, Mich.; CDL:092l6 —G)
00037875 Redenann, C.T. (1961) MetabolIsm of 2—Chloro—6—trichloranethyl —14C_
pyridine in the Dc : GS- 459. (Unpublished study received Jun 6,
1973 under 2F1265; submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL: 09216 4—I)
0003i876 Redemann, C.T. (1962) Residues from 2—Chloro—6—(trlchloranethyl)_
1 1 C—pyridIne In Oats: OS 520. (UnpublIshed study received Jun
6, 1973 under 2F1265; submitted by Dow Chemical U.S.A., Midland
Mich.; CDL:09216 4—J)
00037878 Meikie, R.W.; Williams, E.A.; Redemann, C.T. (1966) Residues from
2-Chloro—6—trIchloromethyl—1 C—pyridIne in Cotton Seed Grown In
the Field: GS 755. (UnpublIshed study received Jun 6, 1973 un—
der 2F1265; submitted by Dow Chemical U.S.A., Midland, Mich.•
CDL: 09216 —L)
00037881 Jensen, D.J.; Miller, P.W. (1973) Studies To Detennine Pos8jble
Bound Residues of 6—Chioropicolinic acid (6—CPA) in Wheat: QH—C
655. (Unpublished study received Jun 6, 1973 under 2F1265; sub-
mitted by Dow Chemical U.S.A., Midland, Mich.; CDL:09216 —p)
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OFFICE OF PESTICIDE PROGRAMS
REXIISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the t ta Base Supporting
Registrations Under the Nitrapyrin Standard
MRID CITATION
00037882 Miller, P.W. (1973) A Canpar’ison of Retention Times of 6-Chloropi-
colinic acid and Some Corrinonly Used Herbicides by Gas Chrornatog—
raphy: GH—C 649. (Unpublished study received Jun 6, 1973 under
2F1265; submitted by Dow Chemical U.S.A., Midland, Nich.; CDL:
092 16 1 4—Q)
00037885 Jensen, D.J. (1970) DetermInation of Residues of 6—Chioropicolinic
acid in Milk by Gas Chromatography. Method ACR 70.1 dated Jan
27, 1970. (Unpublished study received Jun 6, 1973 under 2F1265;
sutmitted by Dow Chemical U.S.A., Midland, Mich.; CDL:09216 4-U)
00037886 Swann, R.L.; Ramsey, J.C., ed. (1972) Determination of Residues of
6—ChioroplcolifliC acid in Plant arti Animal Tissues. Method ACR
71.8R dated Mar 20, 1972. (Unpublished st x1y received Jun 6,
1973 under 2F1265; prepared in cooperation with International
Research and Development Corp., submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:09216 1 4—V)
00037887 Ramsey, J.C., ad. (1971) DetennInation of Residues of 6—Chioropico—
linic acid in Corn, Sorghum, Potatoes, anzl Sugar Beets by Gas
ChranatOgraph .y. Method ACR 71.9 dated Jun 24, 1971. (Unpub—
lished study received Jun 6, 1973 under 2F1265; prepared in co-
operation with WARF Institute, Inc., submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:092164—W)
00037888 Ramsey, J.C.; Jensen, D.J. (1971) Gas Chranatographic Method for
the Determination of 6-Chioropicolinic acid Residues In Eggs.
Metl d ACR 71.15 dated Aug 23, 1971. (TJnpubllshed study re-
ceived Jun 6, 1973 under 2F1265; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:09216 2 4—X)
00038480 Ramsey, J.C.; Rose, J.Q.; Braun, W.H.; at al. (1973) Fate of 6-
ChloropIcolifllC acid following Oral Administration in Rats.
(Unpublished study received Jun 6, 1973 under 2F1265; submitted
by Dow Chemical U.S.A., Midland, Mich.; CDL:092164—O)
00039619 Ramsey, J.C.; Jensen, D.J.; Getzendaner, N.E.; et al. (1971) Resi-
dues of 6—ChloroPlcollniC acid in Sorghum and Sugar Beets.
(Unpublished study including GH-C 469 and ( 1-C 471, received
Apr 29, 1972 under 2F1265; submitted by Dow Chemical U.S.A.,
Midland, Mich.; CDL:092162—E)
00039620 Ramsey, J.C.; Jensen, D.J.; Getzendaner, M.E.; et 81. (1971) Wheat.
Sunmnary of studies 092162—C, 092162—M and 092162—P. (Unpub-
lished study including GH—C 468, received Apr 29, 1972 under
2F1265; prepared in cooperation with Univ. of Idat , Dept. of
Plant Science and Farmland Industries, submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:O92162—F)
—63—
-------
OFFICE OF PESTICIDE PROGRAMS
R ISThATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Nitrap irin Standard
MRID CITATION
00039624 Swarm, R.L.; Ramsey, J.C., ed. (1971) DetermInation of Residues of
6—Chioropicolinic acid in Plant and Animal Tissues. Method ACR
71.8 dated Jun 7, 1971. (Unpublished study received Apr 29,
1972 under 2F1265; prepared in cooperation with International
Research and Development Corp., submitted by Dew Ch nical
U.S.A., Midland, Mich.; CDL:092162—M)
00039625 Ramsey, J.C., ed. (1971) Gas Chranatographic Method for the Deter-
mination of 6—Chloropicolinj.c acid Residues In Wheat. Method
ACR 71.7 dated Jun 7, 1971. (Unpublished study received Apr
29, 1972 under 2F1265; prepared in cooperation with WARF Insti-
tute, Inc., submitted by Dew Che ica1 U.S.A., Midland, Mich.;
CDL: 092162—F)
00040046 Ramsey, J.C. (1971) Residue Studies of 2—Chloro—6--(trichlorome—
thyl) pyridine In Corn Stover, Sorghum Stover, and Wheat Forage
fran Fields Treated with N—serve (R) 24 Nitrogen Stabilizer.
Includes method dated Dec 20, 1971. (Unpublished study received
Apr 29, 1972 under 2F1265; submitted by Dew Ch nical U.S.A.,
Midland, Mich.; CDL:092162-Q)
00040048 KutschInski, A.H.; Turner, G.0.; Watson, A.J.; et al. (1964) De-
termination of 6-Chioropicolinic acid Residues In Silage Corn,
Sweet Corn Kernels and Field Corn Grain Grown on Soil Treated
with N—serve. (Unpublished studs received Apr 29, 1972 under
2F1265; prepared in cooperation with Purdue Univ., submitted
by Dow Ch ical U.S.A., Midland, Mich.; CDL:092162—S)
00040049 Dow Che ical Canpany (1964) Gas Chranatographlc thod for the
Determination of 6—Chiorpicolinic acid Residues in Silage Corn,
Milk—Stage Kernels, and Field Corn Grain. Method ACR 611.1
dated Feb 19, 1964. (Unpublished study received Apr 29, 1972
under 2F1265; CDL:092162—T)
00040050 Ramsey, J.C.; Jenson, D.J.; Getzendaner, M.E.; et al. (1971) Res-
idue Studies of Corn Grain and Stover fran Fields Treated with
N-serve (R) Nitrogen Stabilizer. (Unpublished study received
Apr 29, 1972 under 2F1265; prepared in cooperation with Ridge—
town Technical College, submitted by Dow Chemical U.S.A., Mid-
land, M.Ich.; CDL:092162—U)
00040053 Jensen, D.J.; Duan, R.J.; Turner, G.0. (1970) A Residue Study of
6-Chioropicolinic acid In Cottonseed Milling Fractions: GH—C
407(R). (Unpublished study received Apr 29, 1972 under 2F1265;
prepared in cooperation with WARF Institute, submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:092162—X)
-------
OFFICE OF PESTICIDE PROGRAMS
R ISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Nitrapyrin Standard
MRID CITATION
0001400514 Gentry, W.M.; Bucek, 0.0.; Swart, R.W. (1971) Determination of
6—Chloropicolinic acid in Tissues of Beef Calves Given 6—Chioro—
picolinic acid In the Feed. (Unpublished study receIved Apr
29, 1972 under 2F1265; submitted by Dow Chemical U.S.A., Mid-
land, Mich.; CDL:092162—Y)
000140055 Ramsey, J.C.; Jenson, D.J.; Getzendaner, M.E. (1971) A Residue
Study in Swine Tissues fran Swine Fed 6—Cbloropicolinic acid.
(Unpublished study received Apr 29, 1972 under 2F1265; submit-
ted by Dow Chemical U.S.A., Midland, Mich.; CDL:092162—Z)
000140056 Jensen, D.J. (1971) Assay for residues In milk and cream fran cows
fed 6-Chloropicollnic acid. Journal of Agricultural and Food
Chemistry 19(5):897—899. (Also in unpublished submission re-
ceived Apr 29, 1972 under 2F1265; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:092162—AA)
000140057 Ramsey, J.C.; Jensen, D.J.; Getzendaner, N.E. (1971) A Residue
Study in Chicken Tissues and Eggs fran Chickens Fed 6—Chioro—
picolinic acid. (Unpublished study received Apr 29, 1972 under
2F1265; submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:
092162—An)
000523141 Dinoff, T.M.; Iwata, Y.; Gunther, F.A.; et al. (1979) The Results
of Tests on the Amount of Nitrapyrin and 6-Chioropicolinic acid
Residues Remaining in or on Strawberries, Including a Descrip-
tion of the Analytical Method Used. (Unpublished study received
Jun 24, 1980 under 46 )4-1432; prepared in cooperation with Univ.
of California-—Riverside, South Coast Field Station, Dept. of
Entctnology, submitted by Dow Chemical U.S.A., Midland, Mich.;
CDL: 099484—B)
00052343 Iwata, Y.; Dinoff, T.M.; Bailey, J.B.; et al. (1979) Determination
of Nitrap irin arid 6—Chioropicolinic acid in Strawberry Fruit and
Soil Resulting fran a Preplant Soil Application of N—Serve (H).
(Unpublished study received Jun 214, 1980 under 14614—1432; preared
by Univ. of California--Riverside, Dept. of htanology, submit-
ted by Dow Chemical U.S.A., Midland, Mich.; CDL:099 1 48 ) 4-D)
00052963 Dow Chemical U.S.A. (1980) Residue Studies on Rice. (Canpila—
tion; unpublished study received Sep 4, 1980 under 14614-1432; CDL:
099615—L)
000529614 Jensen, D.J.; Barringer, V.D.; Bjerke, E.L.; et al. (1978) Determi-
nation of 6—Chloropicolinlc acid In Corn, Rice arid Cottonseed.
Met1 d ACH 77.16 dated Feb 17, 1978. (Unpublished study re-
ceived Sep 14, 1980 under 464-432; prepared in cooperation with
WARP Institute, Inc., submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL: 099615—M)
—65—
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Nitrapyrin Standard
MRID CITATION
00076728 Getzendaner, M.E.; Daun, R.J. (1968) A Residue Study of 6—Chioro—
picolinic Acid in or on Cottonseed from the Use of N-serve (‘lyvi)
214 Nitrogen Stabilizer. (Unpublished study received Jun 2, 1981
under 464-1432; prepared in cooperation with Wisconsin Alunril
Research Foundation, submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL: 2145291—A)
00079381 Hamaker, J.W. (1967) The Sorption of 6-Chloropicolinic Acid by
Soils. (Unpublished study received Jul 30, 1981 under 1464—1432;
submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:2 1 45682-E)
00088727 Redemann, C.T. (1961) Metabolism of 2—Chloro—6—trichloromethyl—
C14-pyridine by the Tomato Plant. (Unpublished study received
Mar 2, 1963 under PP0 1 408; submitted by Dow Chemical Co., Indian-
apolis, md.; CDL:0901414O—J)
00088737 Dow Chemical Company (1963) Studies of Residues from Various Chem-
icals in Cottonseed. (Compilation; unpublished study received
Mar 2, 1963 under PP0 1 108; CDL:090)4 1 40—AA)
00101635 Bidlack, H. (1982) Determination of the Bioconcentration Factor
for Nitrapyrin 2—Chloro—6-(trichlorctnethyl)pyrldlne in Blue-
gill Sunfish during Continuous Aqueous Exposure: GH—C 1531.
(Unpublished study received May 19, 1982 under 461 1—1432; sub-
mitted by Dow Chemical U.S.A., Midland, MI; CDL:2 1 47521-A)
001091456 Mendrala, A.; Schumann, A. (1982) N-Serve ¶LY ...: Evaluation of
N—Serve 1t In the Rat Hepatocyte Unscheduled ENA Synthesis
Assay. (Unpublished study received Jul 26, 1982 under 464-1432;
submitted by Dow Chemical U.S.A., Midland, MI; CDL:071017—D)
001091457 Dow Chemical U.S.A. (1982) Results of Tests on the Amount of Res—
Idue Remaining, Including a Description of the Analytical
Method: 6—ChioropicOlinic Acid and Nitrapyrin. (Compilation;
unpublished study received Jul 26, 1982 under 14614—1432; CDL:
0710 17—E)
001102914 McCall, P.; Swaflfl, R. (1978) Nitrapyrin volatility from soil.
Down to Earth 314(3):21 27. (Also In unpublished submission re-
ceived Jun 2, 1978 under 14614—1432; submitted by Dow Chemical
U.S.A., Midland, MI; CDL:2314113—B)
00110296 Fink, R.; Beavers, J.; Grimes, J.; et al. (1978) Final Report:
Acute Oral LD5O——Mallard Duck: Nitrapyrin: Project No. 103—
185. (Unpublished study received Jun 21, 1979 under 14614—432;
prepared by Wildlife International Ltd., submitted by Dow Chem-
ical U.S.A., Midland, MI; CDL:238687—A)
—66—
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OFFICE OF PESTICIDE PROGRAMS
HEXIISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Nitrapyrifl Standard
MRID CITATION
00110297 McCarty, W. (1978) Toxicity of Nitrapyrin to Rainbow Trout and
Bluegill: FS—2’ 8. (Unpublished study received Jun 21, 1979
under 146 - 430; submitted by Dow Chemical U.S.A., Midland, MI;
CDL: 238687—B)
00110298 McCarty, W. (1977) Toxicity of Nitrapyrin to Daphnids: Laboratory
Report Code ES—182. (Unpublished study received Jun 21, 1979
under 4614— 32; submitted by Dow Chemical U.S.A., Midland, MI;
CDL: 238687—C)
00110311 Dow Chemical U.S.A. (1977) The Results of Tests on the Pmount of
Residues Remaining Including a Description of the Analytical
MetiDda. (Ccinpllation; unpublished study received Jun 17, 1977
under 1464—1433; CDL:096193—A)
001103114 Dow Chemical U.S.A. (1979) Residues of 6—Chioropicolinic Acid
in or on Cottonseed. (Ccinpilatlon; unpublished study received
Jun 21, 1979 under ‘46 4—432; CDL:098329—A)
00110318 Jensen, D.; BJerke, E. (1978) A Residue Study: 6—Chioropicolinic
Acid in Corn fran Fields Receiving Sldedress Treathients of N-
Serve Nitrogem Stabilizer: GH—C 1108. (Unpublished study re-
ceived Jul 12, 1978 under 1464—1432; submitted by Dow Chemical
U.S.A., Midlan:1, MI; CDL:097381—A)
00116899 Stevenson, G.; Palm, B.; Lapham, K. (1968) A Game Bird Toxicology
Study-—Acute Dietary Feeding of N-serve and 6-Chioropicolinic
Acid to Japanese Quail: GH—A 375. (Unpublished study received
Apr 29, 1972 under 2F1265; submitted by Dow Chemical Co., mdi-
anapolis, IN; CDL:092161—I)
00116901 Redemann, C.; Williams, E.; Clark, H.; et al. (1966) The excretion
of N— ( 6—chioropicolinoyl ) -glycine by the dog fed 2—chloro-6—
(trichioromethyl) pyridine. Agricultural arxl Food Chemistry 111
(5):530—532. (Also in unpublished submission received Apr 29,
1972 under 2F1265; submitted by Dow Chemical Co., Indianapolis,
IN; CDL:092161—L)
00116902 Redemann, C.; Clark, H. (1967) Fate of 2—chloro—6—(trichlorcznetbyl)
pyridine in the rat. Agricultural and Food Chemistry 15(6):
1127—1128. (Also in unpublished submission received Apr 29,
1972 under 2F1265; submitted by Dow Chemical Co., Indianapolis,
IN; CDL:092161—M)
00116907 Meikie, R.; Austin, S.; Turner, G. (1968) Crop Uptake and Soil
Residues fran 6-Chioropicolinic Acid Applied to Field Soil: OS
9114. (Unpublished study received Apr 29, 1972 under 2F1265;
8Ubmitted by Dow Chemical Co., Indianapolis, IN; CDL:092161—S)
—67—
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base SuPPOrtiri g
Registrations Under the Nitrapyrin Standa
I4RID CITATION
00116919 Youngson, C. (1969) A Study of the Accumulation of 6 —Chloropicolin—
Ic Acid by Aquatic Food Chain Organisms: GS 985. (Unpublished
study received Apr 29, 1972 under 2F1265; submitted by Dow Chem—
ica]. Co., Indianapolis, IN; CDL:092161—AF)
00117010 RegolI, A.; Kurihara, N.; Laskowskl, D. (1974) Soil Degradation
of 114C-Nitrapyrifl, the Active Ingredient of N-serve Nitrogen
Stabilizer. (Unpublished study received Var 1, 19714 under
1464—322; submitted by Dow Chemical U.S.A., Midlarri, MI; CDL:
092166—A)
00117016 Fink, R. (19714) Eight—day Dietary LC5O——Mallard Ducks: 6—Chioro—
2—picolinic Acid: Project No. 103—108. Final rept. (Unpub-
lished study received Mar 1, 1974 under 464—322; prepared by
Truslow Farms, Inc., submitted by Dow Chemical U.S.A., Midlani,
MI; CDL:092166-H)
00117998 Oliver, G.; Swann, R.; Hertel, J. (1982) Anaerobic Soil Degra-
dation of Nitrapyrin: GIl-C 1585. (Unpublished study received
Nov 9, 1982 under 1464—432; submitted by Dow Chemical U.S.A.)
Midland, MI; CDL2148798—A)
GSO213QO1 Bjerke, E.L.; Woods, W.J.; and Kutschiniskl, A.H. (1982) A
residue study of 6—chioropicolinic acid and nitrapyrin in
soybeans. (Unpublished study received 7/26/82 under PP2F2733;
submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:071017).
GS0213002 IR—14 at i tgers (1982) Section D of Petition 2E2757. (Unpub-
lished study received 9/114/82; CDL:071092).
—68—
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0MB Appro vol No. 2000-0468 A?? DIX 21-3
FIFRA SECTION 31C)(2)(S) SUMMARY SHEET
EPA REGISTRATION NO,
PRODUCT NAME
APPLICANT’S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit “generic” data imposed by the FIFRA section 3(CX2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner;
0 1. I will submit data in a timely manner to setisfy 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:
O 2. I have 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
03. I enclose a completed “Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data” with
respect to the following data requirements:
04. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
05. I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
REGISTRANT’S AUTHORIZED REPRESENTATIVE SIGNATURE DATE
EPA Form 58O-1 (104)2)
-69-
-------
APPENDIX 11-4
0M9 Aoøroval No. 2000.0468.
CERTIF1CAT1ON OF ATTEMPT 70 ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To qualify, certify .L four items) FOR DEVELOPMENT OF DATA
GUIDANCE DOCUMENT DATE
1. I am duly 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 ACTIVE INGREDIENT
to submit data concernIng the active ingredient:
NAME OF FIRM EPA COMPANY NUMBER
(This firm or group of firms is referred to below as “my firm”.)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included an offer to be
bopnd 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 date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) 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
-70-
-------
Appendix 111-1
PRODUCT SPECIFIC DATA REPORT
EPA Registration No. Guidance Document for_________
Date
Registration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am canplying with
data requirements by
(For EPA Use Only)
Accession Nunbers
Assi ied
Citing MRID#
Sutinit-
ting
Data
(At—
tached)
15 .20
PRODUCT
CHEMISTRY
61—1
Identity of
ingredients
61—2
Statement of
ccinposition
________
61—3
DiscussIon of
fonnation of
ingredients
62—1
Preliminary
analysis
62—2
Certification of
limits
62—3
Analytical methods
for enforcement
limits
63—2
Color
63—3
Physical state
63—p
Odor
63—5
MeltIng point -
63-6
Boiling point
63—7
DensIty, bulk—
density, or
specific gravity
63—8
Solubillty
63—9
Vapor pressure
____________________
63—10
Dissociation
constant
63—11
Octanol/water
partition
coefficient
63—12
pH
—71—
-------
AppendIx 111-1 (continued)
Registration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
(For EPA Use Only)
Accession Nunbers
Assl&led
Citing MRID#
Submit-
ting
t ta
(At-
tached)
63—13
Stability
63—lL
Oxidizing/reducing
reaction
63—15
F lamriabillty
63—16
ExplodabilIty
63—17
Storage stability
63—18
Viscosity -
63—19
Miscibility
63—20
Corrosion
characteristics
63—21
Dielectric break-
1158. 135
‘IOXICOLOGY
down voltage
81—i
Acute oral LD—50,
rat
bi—2
Acute derynal
LD—50
81—3
Acute Inhalation,
LC—50 rat
8l -L
Primary eye
irritation, rabbit
81-5
Primary dennal
Irritation
81—6
Derinal sensitiza-
tion
_______________________
—72—
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Appendix IV—1
§ 162.10 Labeling requirements.
(a) General—Cl) Contents of the
label. Every pesticide products shill
bear a label containing the Informa-
tion specified by the Act and the regu-
lations In this Part. The contents of a
label must show clearly and promi-
nently the following:
(I) The name, brand, or trademark
under which the product is sold as pre-
scribed In paragraph (b) of this
section;
(ii) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (C) of this section;
(Ill) The net contents as prescribed
in paragraph (dl of this section:
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§ 162.10
Title 40—Protection of Environment
( l v) 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
section:
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(viii) The directions for use as pre-
scribed in paragraph (I) of this section;
and
(ix) The use classification(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility. (I) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render It
likely to be read and understood by
the ordinary individual under custom.
ary conditions of purchase and use.
(ii) All required label text must:
(A) Be set In 6-point or larger type:
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text In other
languages as is considered necessary to
protect the public. When additional
text in another language Is necessary,
all labeling requirements will be ap-
plied equally to both the English and
other-language versions 01 the label-
ing.
(4) PlacJment of Labél—(1) 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 use. If the un-
mediate container Is enclosed within a
wrapper or outside contarner through
which the label cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer. if it is a part of the package as
customarily distributed or sold.
(ii) Tank cars and other bulk con-
tainers—(A) Transportation. While a
pesticide product is In transit, the ap.
propriate provisions of 49 CFR Parts
170-189. concerning the transportation
of hazardous materials, and specifical.
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported in a tank car, tank truck or
other mobile or portable bulk contain.
er, a copy of the accepted label must
be attached to the shipping papers,
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are stored in bulk containers,
whether mobile or stationary, which
remain in the custody of the user, a
copy of the label of labeling, including
all appropriate directions for use, shall
be securely attached to the container
in the immediate vicinity of the dis-
charge control valve.
(5) False or misleading statement.t
Pursuant to section 2(q)(1)(A) of the
Act, a pesticide or a device declared
subject to the Act pursuant to
§ 162,15, Is misbranded If Its labeling is
false or misleading in any particular
including both pesticidal and non-pesO
ticidal claims. Examples of statements
or representations in the labeling
which constitute misbranding include:
(I) A false or misleading. statement
concerning the composition of the
product;
(ii) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device;
(ill) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device:
(iv) A false or misleading comparison
with other pesticides or devices;
(v) Any statement directly or Indi-
rectly Implying that the pesticide or
device Is recommended or endorsed by
-------
Chapter 1.—Environmental Protection Agency
162.10
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;
(vii) 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:
(ix) Claims as to the safety of the
pesticide or Its ingredients, including
statements such as “safe,” “nonpoison-
ous.” “nonmjurious,” “harmiess” or
“nontoxic to humans and pets” with
or without such a qualifying phrase as
“when used as directed”; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) “Contains all natural ingredi-
ents”:
(B) “Among the least toxic chemi-
cais known”
(C) “Pollution approved”
(6) Final printed labeling. (I) Except
as provided in paragraph a)(6)(ii) of
this section. final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision.
ally accepted by the Agency.
(ii) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag.or drum labels.
Such reproductions must b 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:
(I) Is false or misleading, or
(IL) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to § 162.6(b)(4).
(C) Name and address of producer,
registrant, or person for whom pro-
duced. An unqualified name and ad.
dress given on the label shall be con-
sidered as the name and address of the
producer. 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 “ “Distribut-
edby ,“or”Soldby’ • “ 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 (20C)
and shall be expressed in conventional
American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semiso-
lid, viscous or pressurized, or is a mix-
ture of liquid and solid, the net con-
tent 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) Variauon 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 rio case shall the average con-
tent of the packages in a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the time of
registration shall appear on the label.
preceded by the phrase “EPA Regis-
tration No.,” or the phrase “EPA Reg.
No.” The registration number shall be
set In type of a size and style similar to
other print on that part of the label
on which It appears and shall run par-
‘-75—
-------
§ 162.10
Titi. 40—Protection of Environment
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.
(1) Producing establishment-s 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
wrappe? 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 statemeni—( 1) Gener-
a.Z. 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 fox-rn. 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-
ems” and the Inert ingredients by the
term “inert Ingredients,” or the slngu-
lax forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
max-gin and be equally prominent. The
statement ‘lnert Ingredients, none” is
not required for pesticides which con-
tain ,100 percent active ingredients.
Un)ezs the ingredient statement Is a
coxnprete 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.
(ii) The text of the ingredient state-
ment must run parallel with other
text on ‘the panel on which it appears,
and must be clearly distinguishable
from and must 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 propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25(c)(6).
(4) Statements Q( 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%.” II
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active Ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be
present.
(6) Dete,-toration. Pesticides which
change In chemical composition sig-
nificantly must meet the following la-
beling requirements:
(I) In cases where it is determined
that a pesticide formulation changes
chemical composition significantly,
the product must bear the following
statement in a prominent position on
the label: “Not S or sale or use after
(date].”
(I I) The product must meet all label
claims up to the expiration time indi-
cated on the label.
(7) Inert ingredients. The Adminis-
trator may require the name of any
—76—
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Chapter I—Environmental Protection Agency
§ 162.10
inert ingredient(s) to be listed in the
jngredieflt statement if he determines
that such ingredient(s) may pose a
hazard to man or the environment.
(h) Warnings and precautionary
statements. Required warnings and
precaUtionarY statements concerning
the general areas of toxicological
hazard Including hazard to children.
environmental hazard, and physical or
chemical hazard fall into two groups;
those required on the front panel of
the labeling and those which may
(1) Human hazard signal word—(A)
Toztcity Category I. All pesticide prod-
ucts meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word “Danger.” In ad-
dition If the product was assigned to
Toxicity Category I on the basis of Its
oral, Inhalation or dermal toxicity (as
distinct from skin and eye local ef-
fects) the word “Poison” shall appear
In red on a background of distinctly
contrasting cplor and the skull and
crossbones shall appear in Immediate
proximity to the word “poison.”
(B) Toxicity Category 11. All pesti-
cide products meeting the criteria of
Toxicity Category II shall bear on the
front panel the signal word “Warn-
ing.”
(C) Toxicity Category III. All pesti-
cide products meeting the criteria of
Toxicity Category III shall bear on
the front panel the signal word “Cau-
tion.”
CD) Toxicity 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
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 showii by any of the Indicators
in the table below:
Toxicity Category Is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(II) 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.
(III) Statement of practical treat-
ment—(A) Toxicity Category I. A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label 01 all pesticides fall-
ing into Toxicity Category I on the
basis of oral, Inhalation or dernial tox-
icity. The Agency may, however,
permit reasonable variations In the
Hazard indicators
Toxicity Categories
I
I I
Ill ‘
lv
Oral LO..
Up to and including 50
mg/kg.
From 50 Uwu 500 mg/kg..
From 500 thru 5000 mg/
kg.
Greater than 5000 mg/
kg.
InpialatiOn LC..
Up to and including .2
mg/liter.
From .2 thru 2 mg/bter
From 2. 20 rr.g.’Fiter...
than mg/hter.
Dermal LD,.
Up to and including 200
mg/kg.
From 200 thru 2000
From 2,000 thru 20,000....
Greater than 20,000.
Eye effects
Corrosive; corn.aI
opacity not reveraibto
within 1 days.
Cornell opacity
reversible within 7
days; mtation
persisting for 7 dayS.
No comeal opacity;
,rntatiOn reveralble
within 7 days.
No irntat iott.
Skin enacts
Corrosive
Severe irritation at 72
hours,
Moderate wntallon at 72
hours.
Meld or alight irritation at
12 howl.
—77—
-------
§ 162.10
Ttl dO— rotectjort of Environment
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 (h)(1)(lil)(A) of
this section. The applicant may, how-
ever, Include such a front panel state-
ment at his option. Statements of
practical treatment are, however, re-
quired elsewhere on the label in
accord with paragraph (h)(2) of this
section If they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
(Ii) Environmental hazards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
maLs, precautionary statements are re-
quired stating the nature of the
Size of label front panel in square
inches
Required
Signal,
capitais
•‘I( Out
1 . 1CR Of
Children
5endunder
6
6
Above 5 to to
10
6
Above lOto lS
12
8
Above l5to30
Over 30
18
12
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
“Precautionary Statements” and
under appropriate subheadings of
“Hazard to Humans and Domestic Ani-
mals,” “Environmental Hazard” and
“Physical or Chemical Hazard,”
(I) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required Indi-
cating the particular hazard, the
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.
hazard and the appropriate precau-
tions to avoid potential accident,
injury or damage. Examples of the
hazard statements and the circum-
TOXiCit Y
CatI9O tY
Precautionary stat.m.nts by toxicity cat.gory
Oral, inhalation, or derrnaf toxicity
Skin and eye local .fl.Cts
Fatal (poisonous) if swallowed (inhaled er absorbed
through skin]. Do not breathe vapor (Oust or spray
mist). Do not get in eyes, on skin, or on clothing
(Front panel statement of practical treatment re-
quired.].
Corrosive, causes y and skin damage (Or skin
vitIation). Do not get in eyes, on skin, or on
clothing. W.ar pogglU or face Shield and rubber
gloves when handling. Harmful or fatal if Iwallowed
(Appropriat, first aid statethent required.)
II .,
May be fatal if awallowec( (inptal.d or absorbed
through the skin]. Do not breathe vapors (dual or
Spray mist). Do not get in eyef, on skin, Or on
Cuses eye (and skin) entation. Do not get vi eyes.
on skin, or on clothing. Harmful if swat towed. LAp-
propnafe first aid statement required.)
Ill ...,..,,,.
Clothing. (Appropriate t nt aid Øtltemnha required.).
Haniitut it iwallowed (Inhaled Ct absbqbed through the
akin). Avoid breathing vapors (dust or spray mist],
Avoid contact with akin (eyes or clothing). (Appro-
pnate first aid statement required.).
Avoid contact with akin, eyes or Clothing. In case of
contact enmediafely flush eyes or skin with plenty of
water. Gel medical afl.ntion if irritation persists.
lv
(No precautionary Statements required.)
(No precautionary statement, required.)
—78—
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Chapter I—Environmental Protection Agency
§ 162,10
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LID,, of
100 or less, the statement “This Pest!-
dde is Toxic to Wildlife” is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LC,, 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 LD,, of 100
mg/kg or less, or a subacute dietary
LC,, of 500 ppm or less, the statement
“This Pesticide is Toxic to Wildlife” is
required.
CD) If either accident history or field
studies demonstrate that use of the
(1) Thrections for Use—(1) General
requirements—Cl) Adequacy and clar-
ity of directions. Directions for use
must be stated In terms which can be
easily read and understood by the
average person likely to use’or to su-
pervise the u e 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.
(11) Placement of directions for use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
pesticide may result in fatality to
birds, fish or mammals, the statement
“This pesticide is extremely toxic to
wildlife (fish)” is required.
CE) For uses involving follar 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.”
(lii) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
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.
(lit) Exceptions to requirement for
direction for use—CA) Detailed direc-
tions for use may be omitted from la-
beling of pesticides which are intended
Flash point ReqUired text
(A) PRESSUNIZEO CONTAINEPS
Flesh point at or below 20’ F; if there is a flashback at
any valve opening.
Flash point above 20’ F and not over 80’ F or if the
flame extenhiOn us more than 18 in tong at a distance
of 6 in from the flame.
All other pressunzed Containers
Extremely flammable. Contents und.q pressure. Keip away front
tire, sparks. and Mated surfaces. Do not puncture or unc,ner ate
container. Exposure to temperatures above I 30 F may cause
burat in9
Flammable. Contents under pressure. Keep away from heel.
sparks, and open flame. Do not puncture or incinerate container.
Exposure to temperatures above 130’ F may cause bursting.
Contents under pressure. Do not us. or store near heat Or OPSP
flame. Do riot puncture or incinerate container. Exposure to
temperatures above 130’ F may cause bursting.
(B) NONPPESSURIZED CovratNema
and healed
At or below 20’ F
Above 20’ F and not over 80’ F
Above 80’ F and not over 150’ F
Extremely flammable. Keep away tram fire, eperks,
surfaces.
Flammable. Keep sway from beat end open flame.
Do not use or store near heat or open flame.
—79—
-------
§ 162.10
Title 40—Protection of Environment
!or use or.! . by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes,
provided that:
(1) 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;
(3) The product will not come into
the hands of the general public except
after incorporation into finished prod.
uct.s: and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
(1) The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse 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:
(1) There is information readily
available to the formulators on the
composition, toxicity, methods of use,
applicable restrictions or limitations,
and effectiveness ,pf the produ.ct 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;
(3) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; and
T o .\niii trriiur
that such directions are hot necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall include
the following, under the headings “Di-
rections for Use”:
(1) The statement of use classifica-
tion as prescribed in 162.10(J) 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.”
(lii) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vi) The method of application, In-
cluding instructions for dilution, if re-
quired, and type(s) of application ap-
paratus or equipment required.
(vii) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(viii) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(ix) Specific directions concerning
the storage and disposal of the 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 162.10(h)(1)(lv).)
(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)
—80--
-------
Chapt.r 1—EnvironmentOl Protection Agency
§ 162.U
(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 Use Classification.
By October 22. 1976, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (j)(1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with different
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted use(s) except that, if a product
has both restricted use(s) and general
use(s), both of these uses may appear
on & product labeled for restricted use.
Such products shall be subject to the
provisions of 162.1O(J)(2).
(1) General Use Classification. Pesti-
cide products bearing directions for
use(s) classified general shall be la-
beled with the exact words “General
Classification” ‘mmediately below the
heading “Dtre ‘ions for Use.” And ref-
erence to the general classlflc4tOfl
that suggests or implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained in the Directions foT Use will be
considered a false or misleading state-
ment under the statutory definitions
of misbrandin8
(2) Restricted Use Classification.
Pesticide products bearing direction
for use(s) classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
(I) Front panel statement of restrict-
ed use classification. (A) At the top of
the front panel of the label, set In type
of the same minimum sizes as required
for numar hazard signal words (see
table in § 162.lO(h)(1)(iV)), and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to make it unlikely to
be overlooked under customary condi-
tions of purchase and use, the state-
ment “Restricted Use Pesticide” shall
appear.
(B) Directly below this statement on
the front panel, a summarY statement
of the terms of restriction imposed as
a precondition to registration shall
appear. If use Is restricted to certified
applicators, the following statement is
required: “For retail sale to and use
only by Certified Applicators or per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator’s certification.” If,
however, other regulatory restrictions
are Imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertising. (Reserved)
(40 FR 28268, July 3, 1975: 40 FR 32329,
Aug. 1, 1975; 40 FR 36571, Aug. 21. 1975, u
amended at 43 FR 5786, Feb. 9, 1978)
§ 162.11 CriterIa for determination’ of un-
reasonable adverse effects.
(a) Criteria for Issuance of Notice of
Intent to Deny Registration, Cancel
RegtstratiOfl, or to Hold a Hearing—
(1) Presumption. (I) A rebuttable pre-
sumption shall arise that a notice of
intent to deny registration pursuant to
section 3(c)(6) of the Act, a notice of
intent to cancel registration pursuant
to section 6(b)(1) of the Act, or a
notice of intent to hold a hearing to
determine whether the registration
should be cancelled or denied, as ap-
propriate, shall be issued, upon a de-
termination by the Administrator that
the pesticide meets or exceeds any of
the criteria f or risk set forth In para-
graph (a)(3) of this section. Upon auch
determination, the Administrator
shall issue notice by certified mall to
the applicant or registrant, as the case
may ne, stating that the applicant or
registrant has the opportunity to
submit evidence in rebuttal of such
presumption in accordance with para
graph (a)(4) of this section. The appli-
cant or registrant shall have forty-five
—81—
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APPENDIX IV-2
LABELING REQUIREMENTS OF ‘filE FIFRA, AS AMENDED
ITEZ 4
LABEL ELEMENT
APPLICABILITY
OF REQUIREMENT
PLACEMENT ON LABEL
COMMENTS
REQUIRED
PREFERRED
1
Product name
All products
Front panel
Center front
panel
2
Canpany name
and address
All products
None
Bottom front
panel or end
of label text
If registrant is not the producer, must
be qualified by “Packed for . .
“Distributed by.
.,“ etc.
3
Net contents
All products
None
Bottom front
panel or end
of_label_text
.
May be in metric units in addition to
U.S. units
4
EPA Reg. No.
All products
None
Front panel
Must be in similar type size and run
parallel to other type.
5
__________________
EPA Est. No.
All products
None
Front panel,
irrinediately
before or
following
Reg._No.
May appear on the container instead of
the label.
6A
Ingredients
statement
All products
Front panel
I nmnediately
following
product name
Text must run parallel with other text
on the panel.
6B
Pounds/gallon
statement
Liquid products
where dosage
given as lbs.
al/unit area
Front panel
Directly below
the main
ingredients
statement
7
Front panel
precautionary
sta ements
All products
Front panel
All front panel precautionary statements
must be grouped together, preferably
blocked.
7A
Keep C).it of Reach
of thildren
(Child hazard
wam ing)
All products
Front panel
Above signal
word
Note type size requirements.
lB
Signal word
AU products
Front panel
Inmediately
below child
hazard
warning
Note type size requirements.
—82—
-------
AP NDIX IV-2 (continued)
IT 74
LABEL ELE74EJ’IT
APPLICABILITY
OF BJIRE7IEWT
PLACE)1E)I ON LABEL
COMMFRPS
REQtJfl
PRE1 E1 RED
7C
Skull & cross-
bones arid word
EOL ON (in red)
AU products
which are Cat—
egory I based
on oral, der—
mal, or inhala-
tion_toxicity
Front panel
Both in close
proximity to
signal word
7D
Statement of
practical
treatment
All products
in Categories
I, II, and III
Category I:
Front panel
unless refer—
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
for all.
7E
Referral
statement
AU products
where pre-
cautionary
labeling
appears on
other than
front panel.
Front panel
8
SIde/back panel
precautionary
statements
All products
None
Top or side
of back panel
preceding
directions
for_use
Must be grouped under the headings In
BA, 8B, and 8C; preferably blocked.
BA
Hazards to
humans and
danestie
animals
All products
in Categories
I, II, and III
None
Same as above
Must be preceded by appropriate signal
word.
8B
Envirorunental
hazards
AU products
None
Same as above
Envirorinental hazards Include bee
caution where applicable.
—83—
-------
APPENDIX IV-2 (continued)
IT 4
LABEL EL FRT
APPLICABILITY
OF REQUIREI4ENr
PREFERRED
COMMEI TS
REQUIRED
Same as above
C
Physical or
chanical
hazards
AU pressurized
products, others
with flash
points under
150°F
? bne
Preferably
Includes a stat ent of the ter ns of
9A
Restricted
block
All restricted
products
Top
of front
panel
blocked
restriction. The words “RE I’BICTEI) USE
PESTICIDE” must be same type size as
signal word.
9C
Misuse
stat nent
All products
Ininediately
following
heading of
directions
for use
1OA
Reentry
statenent
All
cIx)linesterase
irthibitors
In the
directions
for use
Imnediately
after misuse
statønent
lirinediately
Must be set apart and clearly distin—
100
Storage and
disposal block
All products
In the
directions
for use
before
specific
directions
for use or
at the end of
directions
for_use
None
guishable fran fran other directions
for use.
May be in metric as well as U.S. units
1OD Directions
for_use
All products
Ncne
—84—
-------
•* S•U*IU*s1J.Basl.1.els.l. _ I ..l.pse...I..t**.I..p...* . CROP
FREC&uy0N4R! S7A tME qtS
HAZAROS o HUUAPiS
4 OO&4(S C ANIMALSi
CAUVio
____ PRODUCT
_______________ CROP
________ NAME
Pw 3 AL OR CHEMEAt —
HAZARDS . OJ4•,*img, ..pU$,$us, =
_____________________ ACTNE IOREO N1 _______________
P4EAT IGREVIENYS _____________ —
OlECTK N$ FOR USE _______ _____
TOTAL lOOoO’
THLS PROOUCT CONTAI4 IRS oc PEA GALLON ____
4 • ..ov,.o . f .drs. U. v i . _____
‘ ___________________________________________________________________________
KEEP OUT OF REACH OF CHILDREN I
nt is v S A,tu(fl
- CAUTION _
STORAGE AND
DISPOSAL STAtEMENT OP PRACT* A1. TREAIMENE CROP _____________
______________ 5 OWED
___________________ W P4$A11D ________________________________
o s ’os i. F ON 5*Vd __________________________________ __________________
_________________ F d EYES _______________________________ ________________
____________________ Sit SCE PANEl FOR ADOITONAL PRECAUICNAP.Y STATEMENTS
CROP ________________ _____________________________________________ WARRANTY STATEMENT
• ________________
TOWN STATE _________________
5 SIABIISHMENT NO —
EPA REGISTRATON NO —
NIT CONTENTS _______
-------
Appendix IV-3
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
If the flame extension
is more than 18 inches
long at a distance of
6 inches fran the
valve opening.
C. ALL CiPHER PRESSURIZED
ONTAD RS
II. Non—Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flaahpolnt above 20°F
and not over 80°F.
C. Flashpolnt over 80°F
and not over 150°F.
D. Flaahpoint above
150°F.
Extremely flazmiable.
Contents under pressure.
Keep away fran fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flaninable. Contents under
pressure. Keep away fran
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 flamable. Keep
away fran fire, sparks, and
heated surfaces.
Flamnable. Keep away fran
heat arid open flame.
Do not use or store near
heat and open flame.
None required.
PHYSICAL—CHEMICAL HAZARDS
Required Label Statement
—86—
-------
Appendix W-1
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
“STORAGE AND DISPOSAL.” The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Required type size
Size of label
for the heading
front panel in
square inches
STORAGE AND DISPOSAL
(all capitals)
10 and under . . . . . . . . . . .
. . . .6 point
AbovelO to 15....... . . .
. . . .8 point
Abovel5 to 30....... . . .
. ..10 point
Over 30 . . . . . . . . . . . . . .
. . . 12 point
Storage and disposal instructions must be set apart and
clearly distinguishable fran other directions for use.
Blocking storage and disposal statements with a solid line Is
suggested as a means of increasing their prcznirience.
A. Storage Instructions :
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening arid closing procedures (particularly for
opeiied containers), and measures to minimize exposure
while opening or closing container.
—87—
-------
Appendix IV— 4
(continued)
4. In&ructions on what to do if the container is damaged in
any way, or if the pesticide Is leaking or has been
spilled, and precautions to minimize exposure if damage Occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross—contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
B. Pesticide Disposal Instructions :
The label of all products, except those Intended solely for
danestic use, must bear explicit Instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of’ all products, except danestlc use, must
contain the statement, “DO not contaminate water, food,
or feed by storage or disposal .“
2. Except those products intended solely for danestic use,
the labels of’ all products that contain active Ingredients
appearing on the “Acutely Hazardous” Ccziinercial Pesticide
Prcc ucts List (RCRA “E” List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or der nal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
“Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label Instructions,
contact your State Pesticide or &ivlrorinental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance.”
The labels of all products, except those Intended for
danestic use, containing active or inert Ingredients
that appear on the “Toxic” Cc*iinerclal Pesticide Products
List (RCRA “F” List) at the end of’ this appendix or
presently meet any of the criteria in Subpart C, 140 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
—88--
-------
Appendix IV-4
(continued)
“Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance.”
Labels for all other product8, except tl se intended for
domestic use, must bear the following pesticide disposal
statement:
“Wastes resulting frcm the use of this product may be
disposed of on site or at an approved waste disposal
facility.”
3. Products intended for dctnestic use only must bear the
following disposal statement: “Securely wrap original
container In several layers of newspaper and discard in
trash.”
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products intended for domestic use must bear one
of the following container disposal statements:
Container Type Statement
Non—aerosol products
(bottles, cans, jars)
Do not reuse container (bottle, can, jar).
Rinse thorougjily before discarding in trash.
Non-aerosol products
(bags)
Do not reuse bag. Discard bag in trash.
Aerosol products
Replace cap and discard containers in
trash. Do not incinerate or puncture.
—89—
-------
Appendix IV- 1
(continued)
2 • The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
1, Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
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
arid 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
Fiber drums
with liners
approved state and local procedures.
Ccinpletely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. anpty 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
reusedi, dispose of In the same manner.
Paper and
plastic bags
Canpletely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Canpressed g
cylinders
Return empty cylinder for reuse (or
similar wording)
—90—
-------
Appendix IV- 1 4
(continued)
Pesticides that are hazardous wastes under 140 CuR 261.33(e) and (f)
when discarded.
“ Acutely Hazardous” Ccmiiercial Pesticides (RCRA “E” List)
Active Ingredients, (no inerts) :
Acrolein
A ldicarb
A ldr’in
Allyl alcohol
Aluminum phosphide
14-Aininopyrldine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroanil the
Cyanid€ s (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-CycloheXyl-14 ,6—dinltrophenol
Dieldrin
o , 0—Dieth .yl S— [ 2—ethylthio )etbyl] phosphorodithioate
(disulfoton, Di—Sys ton)
0,0—Diethyl 0—pyrazinyl phosphorothloate (Zinophos)
Dimethoate
0,0-Dimethyl 0-p—nitropheflyl phosphorcthioate (methyl parathion)
14, 6—Dinltro—o—cresol and salts
14, 6—Dinltro—o—cyclohexylphenOl
2,14 Dinitrophenol
Dinoseb
ErKiosulfan
En:iothall
Endrin
Pamphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methariyl
alpha-NaphthylthiOUrea (ANTU)
Nicotine and salts
Qetamethylpyrophosphoramide (CMPA, schradan)
Parathion
—91—
-------
Appendix W-L
(continued)
“ Acutely Hazardous” Caitnercial Pesticides (RCRA “E” List)
Active Ingredients continued :
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0, 0—Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
—92—
-------
Appendix W-li
(continued)
“ Toxic” Ccmnercial Pesticide Products (RCRA “F” L18t)
Active Ingredients :
Acetone
Acrylon .tri1e
M it role
Benzene
Bis ( 2—ethyihexyl )pthalate
Cacodylic acid
Carbon tetrachioride
Chioral (hydrate)
Chiordarie (technical)
Chlorobenzene
—Chloro—m-cresol
Chloroform
o—Chloro *ienol
L —Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
DecachlorooctahydrO-l , 3, 1 4-metheno—2H—cyclobuta [ c ,d]—pentalen-2—one
(kepone, chiordecone)
1, 2—Dibrcn o-3-chlorOprOpane (DBCP)
Dibutyl phthalate
S—3 , 3- (Dichloroallyl dilsopropyithiocarbamate (diallate, Avadex)
o—Dichlorobenzene
p—Dichlorobeflzefle
Dichlorodifluorarletharle (Freon 12®)
3, 5-Dichloro-N— (1, 1-dimethyl-2—propynyl) benzamide (pronamide, Kerb)
Dichioro diphenyl dichioroethane (DDD)
Dichioro diphenyl trichioroethane (DDr)
Dichlort.sthyl ether
2,k—Dich].orophenoxyaCetic, esters and salts (2, 1 4—D)
1, 2-Dichioropropane
1, 3—Dichioropropane (Telone)
Diinethyl phthalate
Ethyl acetate
Ethyl ! ‘—dlohlorobenzilate (chlorobenzilate)
Ethylene dibrai ide (EDB)
Ethylene dichioride
Ethylene oxide
Formaldehyde
Furf’ural
Hexachlorobeflzefle
Hexachiorocyclopentadiefle
Hexachloroetharle
Hydrofluoric acid
-93-
-------
Appendix IV—4
(continued)
“ Toxic” Caiinercial Pesticide Products (RCRA “F” List)
Active Ingredients :
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl brctnide
Methyl thioride
2,2 ‘-Methylenebls (3, L ,6—trichlorophenol) (hexachiorophene)
Methylene chloride
Methyl ethyl ketone
1 -Methy1-2—pentanone (methyl isobutyl ketone)
Naphthalene
Nltrobenzene
p—Nitrophenol
Pentachioroethane
Pentachloronltrobenzene (PCNB)
Pentaclorophenol
Phenol
Pl sphorodithio1c acid, 0,0—diethyl, methyl ester
Propylene dichioride
Pyridine
Resorcinol
Saf role
Selenium disulfide
Silvex
1,2, LI, 5—Tetrachlorobenzene
1,1,2,2—Pet rachloroethane
Tetrachioroethy lene
2,3, LI, 6—Pet rachiorophenol
Thiram
Toluene
1,1 , 1—Trichloroethane
Trichloroethylene
Trichlcrctnonofluoranethane (Freon li®)
2, LI, 5—Trichiorophenol
2, LI, 6—Trichiorophenol
2, 14 ,5—Trichlorophenoxyacetic acid (2, LI ,5—T)
Xylene
—94-
-------
Appendix iV-
(continued)
“ Toxic” Ccninercial Pe8ticide Products (RCRA “F” List)
Inert Ingredients :
Acetone Formaldehyde
Acetonitrile Formic acid
Acetophenone Isobutyl alcohol
Acrylic acid Meleic anhydride
Aniline Methyl alcohol (methanol)
Benzene Methyl ethyl ketorie
Chlorobenzene Methyl methacrylate
Chloroform Naphthalene
Cyclohexane Saccharin and salts
Cyclohexanone Thiourea
Dichiorodifluoranetharie (Freon 12®) Toluene
Diethyl phthalate l,l,l—Tr’ichloroethane
D1meth , lamine 1,1, 2-Trichioroethane
Dlmetiiyl phthalate Trichlorofluorcmethane (Freon 11 )
1, 4—Dloxane Vinyl chloride
Ethylene oxide X.ylene
-95—
------- |