Unhid Statea
Environmental Protection
Ad»ncv
Off lo* of
PwticidM and Toxic Subatanoaa
Wafhington DC 20460
PMicidM
&EPA
[March 1985J"
Guidance for the Reregistration
of Pesticide Products
Containing Naptalam
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GUIDANCE FOR THF
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
NAPTALAM/NAPTALAM SODIUM
AS THE ACTIVE INGREDIENT
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
Introduction
I. Requjatory Position and Rationale
II. Requirement for Submission of Generic Data
III. Submission of Revised Lahe)inq
A. Label Contents . . . . .
1. Product Name
2. Com anv Name and Address
3. Net Contents
4. Product Recistration Number
5. Producina stahlishment
Registration Number
6A Inqredient Statement
GB Pounds Per Gallon Statement
7. Front Panel Precautionary Statements
7A Child Hazard Warning Statements.
7B Sianal Word
7C Skull and Crossbones and Word Poison
7D Statement of Practical Treatment
7E Referral Statement
8. Side/Back Panel Precautionary Labeling
8A Hazard to Humans and Domestic Animals.
8B Environmental Hazard . . . . . . .
RC Physical or Chemical Hazard.
9 Misuse Statement
1OA Storaae and Disposal Block
lOB Directions for rise
B. Collateral Information
IV. Instructions for Submission
4
12
37
37
• • .
37
38
• . • . • 38
38
38
38
39
39
39
39
39
39
39
40
40
41
41
41
41
42
1.
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APPENDICFS
Paae
1 1—1 Guide to Ribliocraphy . . . . . . . . 44
11—2 Bibliooraphy . 46
11—3 FIFRA 3(c)(2)(B) Summary Sheet — EPA Form RSRO—1 . . 53
11—4 Certification of Attempt to Enter Into an Aqreement
with Other Recistrants for DeveloPment of Data
PA Form RSRO—2. . . . . . . . . . . . • 55
1 1 1—1 Product Specific Data Report (End—tJse Products) • . 56
n T— i 40 CF’R 162.10 Labeling Requirements 58
P 1—2 Table of Labelina Reauirements 67
IV-3 Physical/Chemical Razards Labelina Statement. . . . 70
IV—4 Storage and Disposal Instructions 71
ii
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I WPRODUCT ION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA sec. 3(q)) directs EPA to rereqister all pesticides as
expeditiously as possible.
To carry out this task, EPA has established the Regis-
tration Standards program, which will review all pesticide
products containing active ingredients first registered hefore
January i, 1q77. Pesticides will be reviewed in use clusters
which have been ranked to give earliest review to pesticides
used on food and feed crops.
The Recistration Standards program involves a thorough
review of the scientific data base underlying pesticide
reqistrations 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. T PA’S reassessment results in the development
of a regulatory oosition, contained in a Registration Standard,
on each pesticide and its uses. The Agency may require the
registrant to modify product labels to provide additional
precautionary statements, restrict the use of the pesticide
to certified applicators, provide reentry intervals, modify
uses or formulation types, specify certain packaging limitations,
or other requirements to assure that proper use of the pesticide
will not result in adverse effects on the environment.
The scientific review, which is not contained in this
Guidance Package but is available upon request, concentrates
on the technical grade of the active ingredient and identifies
missing generic data. However, during the review of these
data we are also looking for potential hazards that may be
associated with the end use (formulated) products that contain
the active ingredient. If we have serious concerns, we will
address end use products as part of the Registration Standards
program and will propose regulatory actions to the extent neces-
sary to protect the pubjic.
EPA has the authority under FIFRA sec. 3(c)(2)(B) to
require registrants to submit data that will answer our
questions regardinq the hazard that may result from the
intended use of a pesticide. Although sec. 3(c)(2)(R) provides
that all registrants are responsible for these data, the
Agency generally imposes qeneric data requirements only on the
registrants of of the manufacturinq use products (basic
suppliers of the active ingredient). End use producers who
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do not qualify for the formulator’s exemption* are also
reauired to submit these data.
An end use producer who wishes to qualify for the formu-
lator’s exemption may change his source of supply to a reqistered
source, provided the source does not share ownership in
common with the registrant’s firm. An end use registrant
may do so by submitting a new Confidential Statement of
Formula, EPA Form 8570—4, identifying the reqistered source
of the active ingredient, to the aporo riate Product Manager
within 90 days of receipt of this Guidance Document. The
chart on the followinq pace shows what is qenerally reauired
of those who do and do not qualify for the formulator’s
exemption in the Registration standards program.
If you decide to request the Aaency to cancel the regis-
tration of any of your products subiect to the reauirements
of this Guidance Document, please notify the Product Manager
named in the cover letter, within 9( days from the receipt
of this document. If you decide to maintain your product
reqistration(s), you must provide the information described in
the following paces within the timeframes outlined. EPA will
issue a notice of intent to cancel or suspend the registration
of any currently recistered product which does not comply
with the requirements set forth in this Guidance Document.
You are reminded that FIFRA sec. 6(a)(2) requires you to
submit factual information raising concerns of possible
unreasonable adverse effects of a pesticide. You should
notify the Agency of interim results of studies in progress
if those results show possible adverse effects.
*The formulator’s exemption applies to a registrant of an
end use product if the source of his active inaredient(s):
(1) is reqistered product and (2) is purchased from a source
which does not have ownership in common with the recistrant’s
Firm.
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I PRODUCTS SUBJECT TO THE I ACTION(S) REQUIRED TO I
I REGISTRATION STANDARDS PROGRAM MAINTAIN REGISTRATION I
II. Products That Do Not Qualify I
I For The Formulator’s Exemption I
I I I
I A. Sinqle Active Inqredient I These products must he rereais- I
I Products* I tered. To obtain rer gistrat ion, I
I I labelina, packagina and data I
I I requirements must be satisfied I
I I in accordance with the Reals- I
I I tration Standards Guidance I
I I Document. I
I . I .1...
I B. Multiple Active Inaredient I These oroducts will not he I
I Products I rereqistered at this time. I
I I However, generic data reauir d I
I to continue the registration of I
I I the active inqredient under I
I review, as described in the I
I I Reqistration Standards Guidance
I I Document, will be reauired and I
I I some labeling precautions may I
I I also be required. I
I I
I I I
III. Products That Do Qualify For I Only when additional restric- I
I The Formulator’s Exemption I tions or labeling are needed to I
I I protect man or the environment I
I I will these products be subiect I
I I to the Registration Standard I
I I requirements. Affected products
I I will be dealt with in a variety I
I I of ways, including but not
I limited to the Label trnprovementl
I I Program and special intent
I to cancel notices.
J* End use products of registrants who also produce a manufacturing
Iuse product will not be recuired to be rereqistered provided that I
Ireqistrant fulfills the requirements specified in the Guidance
IDocument for manufacturing use oroduct(s). such end use oroducts I
Iwill be sub-iect to the labeling chanaes reauired for products in “IT” I
labove. If there are no manufacturing use products registered by any I
Icompany end use products will be required to be rereaistered. I
I I
INOTE: If all registrants in “I” above fail to meet the requirements ml
lI—A and B above, then the registrants in “II” lose their riaht to I
Iaualifv for the formulator’s exemption and become subiect to the I
Ireguirements in I—A and B. I
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I. Regulatory sition and Rationale
A. Introduction
This Registration Standard describes the regulatory position and rationale
for all req istered manufacturina-use products (MPs) and end-use products
(EPs) containing the herbicide naptalan sodium as the sole active inqredient.
The Pi ency bases its position and rationale on an evaluation of all such
products and Section 3, 24(c) and intrastate uses for naptalan sodium.
F d—use products have been inclLx3ed in this Standard because at the time of
publication there were no registered MPS. After briefly describinq the
chenical and its uses, this chapter presents the regulatory position and
rationale, the criteria for registration, acceptable ranges and limits,
labeling cons iderat ions and tolerance reasses ent.
B. Use Profile
Naptalan sodium is a pre— or post nerqent phthalic acid tyce herbicide which
selectively controls germinating annual grasses and broadleaved weeds. The
registered formulations are an emulsifiable concentrate (EC) and a soluble
liauid concentrate (SC/L) of 2.0 lbs active ingredient er gallon (23.7% ai),
and a aranular product (lO.R% ai). The kency has registered naptalam sodium
for use on the following sites: soybeans, peanuts, cucurbits (cantaloupe,
cucumber, nuskmelon, termelon), cranberries, and ody nursery stock.
Soybeans are the largest naptalan sodium use site. Aiproxisnately four percent
of the soybean acreage in the United States is treated each year with naptalam
sodium. Use on soybeans accounts for 92 percent of the annual na talam sodium
production. Use on peanuts accounts for another 7 percent, and uses on cucurbits,
cranberries, and ornamental nursery w,odv stock account for the balance.
ien applied preemergence, naptalam sodium is applied to the soil surface
within 48 hours after plantinq, either as a broadcast or banded soray (liquid
formulations) or as a granular herbicide. Naptalam sodium can also he applied
as an overt application when soybeans are about 18 inches tall, or post erqence
in cucurbits before the crop starts to vine and before weeds emerge. oily
one apol ication is permitted per year, except on cucurbits, where a second
application may be used. The application rate for the EC formulation is
2.0—6.0 lbs ai/A, except on ornamental nursery stock, where up to 8.0 lbs ai/A
may be used. The application rate for the granular formulation is 4.3 lbs ai/A,
except on cranberries, where 8.1 lbs ai/A is used. Naptalam sodium may be
applied with ground equi nent on all sites, and the EC formulation may be
applied fran the air on all sites except ornamental nursery stock.
Tank mixes labeled for use with naptalam sodium are: with bensulide in cucurbits
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with dinoseb, metolachior, benef in, vernolate, trifluralin, and dinitranine,
2,4—Ce or dinethylamine salt of 2,4—DB in peanuts; with dincseb, 2,4—tB,
alachior, metolach].or, netribizin, oryzalin, or alachior and netribizin in
soybeans. It is also available as a package mix with dinoseb and 2,4—tB, and
has nn.iltiple active registrations with chlorprcphain (includes the cranberry site)
and dincseb. Tank mixes and other multiple active ingredient products are not
covered by the registration standard process at this tune.
C. Background and Description of the Chemcal
Naptalan sodiun is the cannon nane for the herbicide sodiun
N—l-naphthyiphthalanate. The Chemical Abetracts Service (CAS) n .nther for
naptalan is 132-66-1, and the EPA Chemical Code number (also knc in as the
au inessy number) is 030703. The trade name for naptalam sodium is
Alanap-L®. Naptalan was first develcped in 1949 by the Uniroyal Chemical
Carpany. Uniroyal is the only manufacturer of naptalam, and the only
registrant of products with naptalan sodiun as the sole active ir redient.
Both naptalam and naptalam sodium salt are purple, crystalline solids.
They have melting points of 185 C and 234°C, and specific gravities of
1.362 and 1.386, respectively. Solubilities in cannon solvents (in g/l00
ml) are as foU ,s:
Solvent Naptalamn Naptalam, Sodium
ter 0.02 30.0
Acetone 0.59 1.68
Xylene * 0.04
Benzene * 0.05
Re ne * *
chloroform o.oi *
114F 3.94 5.53
E1’ISO 4.31 140.0
Ether 0.11 0.01
2—prcpano]. 0.21 2.09
ME 0.37 0.59
* Insoluble in this solvent
Naptalam Is not stable above pH 9.5 or above 18 0°C • It tends to form the
imide at elevated talperatures. Very hard water and water with l i pH
may cause precipitation of free acid f ran solution of naptalam sodium.
Naptalan sodium is incaipatible with sane pe ticides. High electrolyte
may be a problem in mixtures with soluble fertilizers.
Naptalan is readily abeorbed by roots or foli e, and can be translocated fran
the roots to the leaves. Its node of action is the blocking of indoleacetic
acid (IAA) action.
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D. Regulatory Position and Rationale
Based on a review and evaluation of all available data and other relevant
information on naptalam, the Agency has made the following determinations:
1. Manufacturing—use and end—use pesticide prcx:lucts containing naptalam sodium
as a sole active ingredient may be registered for sale, distribution,
reformulation, and use, 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,
to pel:init new EP registrations, or to register technicals or MPs.
Rationale: The Agency’s data base on naptalam sodium is not ccinplete. The
Agency requires the data specified in Table A to canplete its analysis of
the risks and benefits associated with continued reiistration of naptalam
sodium products. Under FIFRA, the Agency cannot cancel or withold registration
simply because data are missing or inadequate (see sections 3(c)(2)(B) and
3(c)(7) of FIFRA). Rather, issuance of this Standard provides a mechanism
for identifying data needs. These data will be reviewed and evaluated when
they are received and the Agency will determine at that time if they will
affect the registration(s) of naptalam sodium products.
2. Groundwater monitoring data will not be required at this time.
Rationale: Because it is water soluble, naptalam sodium has sane potential
to leach into groundwater, but there is virtually no envirorinental fate
data (e.g. leaching, soil metabolism, etc) available, and the Agency has
not received any report of naptalam sodium being found in groundwater.
Therefore, although groundwater monitoring data are not required at this time,
they may be required later, once the Agency has received and reviewed the
envirorinental fate data listed in Table A.
3. The Agency will require registrants to place certain precautionary statements
on the labels of MPs and EPs containing naptalam sodium. The specific
language of these statements is given in Section G of this Standard.
Rationale: Because of the toxicola ica1 properties of rtaptalam sodium, certain
precautionary statements are required on labels as a means of minimizing the
exposure of humans and non—target wildlife. For example, eye irritation
studies on the rabbit indicate potential for serious eye damage. Therefore
the Agency will require label statements warning of the hazard and recuiring
handlers to wear a face shield or goggles. Section G lists all required
statements.
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4. The grazing restrictions on current soybean—use labels will be maintained.
Rationale: Until data concerning the existence and persistence of residues on
soybeans, soybean forage, and soybean hay have been submitted and analyzed,
current grazing restrictions will minimize chances of residues in animal
products. MonitorirY of residues in soybean forae is required to determine
residue levels.
5. Reentry intervals will not be required.
Rationale: The Agency has determined, based on the use patterns and available
toxicology data, that the criteria in §158.140 have not been met. When the
pesticide is applied to the soil at or irrmediately following planting, workers
entering the field after applications should encounter minimal dermal and
inhalation exposure, regardless of what formulation is used. When the pesticide
is applied postplant to soybeans, sane workers’ lcmer legs could be exposed by
brushing against the bean plants. However, because no dermal toxicity data are
available, the hazards of such exposure cannot be estimated. Thus, the
requir nent of a reentry interval at this time would be prenature. The Agency
will revi ’ dermal and inhalation toxicity data as it is received in response
to this Standard and the accanpanying 3(c)(2)(B) letter, and will determine
after that review whether to require a reentry interval.
6. New studies, conducted to fulfill data requirelientS listed in Table A, must
be run using the technical gr ie of the sodium salt, where the table indicates
“TG J” as the proper test substance. Because there is no registered technical
grale in this case, the technical grade will be defined as the purest form
of the sodium salt of naptalam resulting fran a typical manufacturing
process, i.e. the grade of the material immediately prior to the formulation
of end—use products. Data fran chronic toxicity studies in which the pure
acid or salt was used may be used to support registrations if the registrant
can properly identify the substance and justify its use. Furthermore, clear
identification of all EPs, e.g. the 23.7 percent a.i., et al used as testing
materials (and their contaminants) is required before the data obtained can be
evaluated. Sane current toxicological data gaps may be filled by existing data,
if identification of the testing materials is canpieted by the registrant.
Rationale: The Agency usually requires data on the technical prade of the
manufacturing—Use product. There is no registered manufacturingUSe product
in this case; sodium naptalam products are produced via an integrated
formulation process. Therefore the appropriate test substance is the purest
form of the sodium salt resulting f ran a typical manufacturing process.
Studies using the pure acid or salt may offer sufficient toxicological
information to support registration, if the registrant can identify the
substance used and justify its use.
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7. At least until the required data on plant metabolism and field residues
are sul nitted and reviewed, the Agency will require the labels of all
products registered for use on soybeans to bear a stat ent prohibiting use
within ninety days of harvest.
Rationale: The data available on the residues r naining on soybeans up to
ninety days post—treatment are insufficient to allow proper evaluation of
the potential hazards they pose. Imposition of a ninety—day post—treath ent
interval will reduce the potential exposure to possibly harmful residue
levels.
8. The Agency will not approve additional tolerances for significant n crops
until data gaps regarding acute toxicity, teratogenicity, oncc enicity,
plant and animal metabolism, storage stability, reproductive effects, and
environmental fate are filled. No new tolerances will be granted until
the data required to support the new tolerances are su1 itted.
Rationale: The virtual lack of toxicity and envirorinental fate data prevent
evaluation of the hazards posed by use of naptalam sodium. In the absence of
positive evidence of hazard, existing registrations may be maintained, but the
increased exposure rates that would result fran significant new tolerances
and registrations could increase hazards that are as yet unreccx nized, due
to the extensive data gaps.
E. Criteria for Registration Under This Standard
lb be covered by this Standard, products must:
o contain naptalan sodium as the sole active ingredient, and
o bear required labeling and conform to the product canposit ion,
acute toxicity limits, and use pattern requir ents listed in
Sections F and G 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.
This includes making a caunitment to fill data gaps on a schedule specified
by the Agency. 1 pplicants for registration under this Standard must follow
the instructions contained in this guidance package and canplete and sutrait
the appropriate forms within the time specified.
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F. Acceptable Ranqes and Limits
( te: At the time of publication of this St rndard, no manufacturing—use
products (MPs) have been reqistered for use, nor are any proposed for
registration. References to the requirement:; for MPs refer to any future
registrations.)
1. Product Ccxnposition Standard
To be fully covered under this quidance docunent, MPs and EPs must contain
naptalam sodium as the sole active inqredienb. Each product formulation
proposed for registration must be fully described with an a ropriate
certification of limits. In addition, the a tive ingredient found in the
naptalan products must be substantially similar to that in currently recistered
products. Any product not meeting these reauirements will be cons idered a
new product and will not be registered under this Standard.
2. Acute ¶Ibxicity Limits
The Agency will consider registration of MP and EPs containing naptalam
sodium s’ hen the product is supported by acute toxicity data and the labelinq
of the product bears the aporopriate precaut ionary statements.
3. Use Patterns
be registered under this Standard, MPS containing naptalam sodium must
be labeled for formulation into EPs that arE to be used for the control of
weeds in cranberries, peanuts, soybeans, cx3y nursery stock, or cucurbits.
EPs imist be labeled for use on these same cii nothties.
G. Required Labeling
All technical grade and manufacturing—Use poducts containing naptalam sodium
must bear appropriate labeling as specified in 40 CFR 162.10. Other portions
of the guidance package contain specific in ormatiOn regarding label
requirements. In addition, the following si cific labeling requirements apply:
1. Use Pattern Statements :
Labels of all MPs must bear the statement:
“For formulation into end-use herbicide products intended only for use on
soybeans, peanuts, cucurbits, cranberries, or ‘xxr9v nursery stock.”
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2. Precautionary Statements
Labels of MPs and EPs must bear the statements:
a. Hazards to Humans Statements
“t NGER: Harmful if swallowed. Corrosive. Causes irreversible eye
damage. Lb not get in eyes or on clothing. Wear a face shield or
goggles. Wash thoroughly with soap and water after handling and
before eating or smoking. Remove contaminated clothing and wash
before reuse.” and;
b. Statements of practical Treatment
“ If in eyes : Flush with water for fifteen minutes. Call a physician.”
“ If swallowed : Call a physician or Poison Control Center. Drink
pranptly a large quantity of milk, gelatin solution, or, if these are
not available, drink large quantities of water. Avoid alcohol. NOTE
ID PHYSICL iN : probable mucosal damage may contraindicate the use of
gastric lavage.”
c. Environmental Hazard Statement
The following specific statements must appear on the labels of all MPs:
“tb not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or public waters unless this product is
specifically identified and addressed in a NPDES permit. Tb not
discharge effluent containing this product to sewer systems without
previously notifying the sewage treatment plant authority. For guidance
contact your State Water Board or Regional Office of the EPA.”
The labels of EPs intended for outdoor use must bear one of the following
statements, depending on the formulation of the product:
Granular products must bear the statement:
“Lb not apply directly to water. In case of spills, collect for reuse
or properly dispose of the granules. Lb not contaminate water by
cleaning of equipnent or disposal of wastes.”
Non—granular products must bear the statement:
“Lb not apply directly to water. Lb not contaminate water by cleaning
of equi nent or disposal of wastes.”
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d. Grazing Restrictions Statement
The labels of all EPs registered for use cn peanuts must bear the
stat nt:
“lX not graze or feed forage or hay fran treated peanuts to livestock.
The labels of all EPs registered for use cn soybeans must bear the
statement:
“tX not harvest soybeans or soybean hay earlier than 90 days
post—treatment. L not graze or feed forage or hay fran treated
fields to livestock.”
The labels of all products must bear the appropriate container disposal
statement. See Appendix IV—5 of this guidance package.
The required statements listed in this Stanctar i must appear on the labels
of all MPs and EP5 released for shi xnent after March 1, 1986. The labels
of all MPs and EPs currently in the channels; ot trade must be mcdif led to
include all the listed statements by March ., 1987. After review of data
to be sukrnitted under this Standard, the j ncy may impose additional
label requirements.
H. Thlerance Reasses neflt
Tolerances of 0.10 ppn (considered negligibLe) have been established for
the residues of naptalam in or on certain r w agricultural food cc m dities
such as cantaloups, cranberries, cucumbers, muskinelons, peanuts, soybeans,
and watermelons. (See 40 CE’R 180.297.) An acceptable daily intake (ADI)
for man has not been set, because no valid thronic feeding study data are
available. A provisional acceptable daily intake (PADI) was set at
0.0375 iw /kg/day, based on a 13—week subchrDnic dcxi feeding study with a
no effect level (NOEL) of 3000 p zn, and a safety factor of 2000. Based on
this PADI, a maxirnun permissible intake (MPL) was set at 2.25 n j/day for a
60 kg female. However, the study on which the PADI was based has been
reclassified Core Supplementary, and no other data are available on which
to base a new PADI. Therefore at present there is no valid PADI nor ADI.
A new ADI will be calculated when the PQency receives, reviews, and
classifies as Core Minimum, a two—year feeding study in rats or a one—year
feeding study in dcgs.
International Tolerances
The follcwing Canadian tolerances exist for the residues of naptalam.
There are no Mexican tolerances or Codex Maximum Residue Limits (MRLs)
for residues of naptalam sodium.
X*1M3DITY ( PPM )
Cantaloups 0.10
CranberrieS 0.10
Cucumbers 0.10
Melons 0.10
Soybeans 0.10
watermelons 0.10
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II. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA sec. 3(c)(2)(B). The
tables following this section list the data required for
maintaining the registrability of each product.
EPA has determined that additional generic data described
in Table A must be submitted to EPA for evaluation in order
to maintain in effect the registration(s) of your oroduct(s)
identified as an attachment to the cover letter accornpanvinq
this guidance document. As required by FIFRA sec. 3(c)(2)(R),
you are required to take appropriate steps to comply with
this Notice.
EPA may susoend the registration of each of those oroducts
unless, within the soecified time, you have informed FPA how
you will satisfy the reauirements of this Notice. Any such
susPension will remain in effect until you have complied with
the terms of this Notice.
B. What Generic Data / Must be Submitted . You may deter-
mine which generic data you must submit by consulting Table A
at the end of this chapter. That table lists the aeneric
data needed to evaluate the continued registrability of all
products, and the dates by which the data must be submitted.
The required studies must be conducted in accordance with
EPA approved protocols (such as those contained in the Pesticide
Assessment Guidelines 2/ or data collected under the aporoved
protocols of the Organization for Economic Cooperation and
Development (OECD). If you do not wish to develop data
in support of certain uses appearing in your labelina, you
may delete those uses at the time you submit your revised
label ing.
For certain kinds of testing (generally ecoloqical
effects), EPA reauires 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 inqredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient, regardless
of the product’s uniaue composition or specific use. Product—
specific data relate only to the properties or effects of a
product with a particular composition (or a arouo 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, Sprinqfield, Va. 22161.
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for each major formulation cateqory (e.g., emulsifiable concen-
trates, wettable powders, granulars, etc.) These are classified
as generic data and when needed are specified in Table A.
EPA may possess data on certain “typical formulations” but
not others. Note : “Typical formulation” data should not be
confused with product-specific data (Table B) which are
required on each formulation. Product-specific data are
further explained in Chapter III of this document.
C. Options Available for Complying With Reauirements to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled “FIFRA
Section 3(c)(2)(B) Summary Sheet” [ EPA Form 8580—1, Appendix
11—3) for each of your products. On that form you must state
which of the followina methods you will use to comply with
the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existinq data you believe will
satisfy the reauirement, or state that you will aenerate
the data by conducting testing. If the test procedures
you will use deviate from (or are not specified in) the
Pesticide Assessment Guidelines or protocols contained in
the Reports of Expert Groups to the Chemicals Group,
Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must enclose the
protocols you will use.
OR
2. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly deve1o (or
share in the cost of developinq) 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 comoleted “Certification of Attempt to
Enter Into an Agreement With Other Registrants for Develop-
ment of Data” (EPA Form 8580—6, Appendix II_4)*/
*1 FIFRA sec. 3(c)(2)(B) authorizes loint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator’s decision if they agree
to jointly develop data but fail to aqree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
(Footnote continued on next page)
—13—
-------
OR
4. Request that EPA amend your registration by deleting
the uses for which the data are needed. (This option is
not available to applicants for new products.)
OR
5. Request voluntary cancellation of the registration(s)
of your products for which the data are needed. (This option
is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testinc Methodology
and Extensions of Time
EPA recoanizes that you may disagree with our conclusions
regardinq the appropriate ways to develop the required data
or how auickly the data must he submitted. If the test
procedures you plan to use deviate from (or are not specified
in) the reaistration guidelines or protocols contained in
the reports of the Expert ( roups to the Chemical (rouOS,
Organization for Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must submit the protocol
for Aqency 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 aqreemeflt
among all such registrants is clearly in the public interest.
Duplication of testinq could increase costs, tie up testina
facilities, and subject an unnecessarily large number of
animals to testinq.
As noted earlier, EPA has discretion to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). EPA has concluded that
it should encourage -loint testinq rather than duplicative
testing, and that suspension should be withheld in certain cases.
to further this goal. Accordingly, if (1) a registrant has
informed us of his intent to develoo and submit data required
by this Notice; and (2) a second registrant informs EPA that
it has made a bona fide offer to the first recistrant to share
in the expenses of the testinq ron terms to be agreed upon
or determined by arbitration under FIFRA Section 3(c)(2)(B)(iii)1;
and (3) the first registrant has declined to agree to enter
into a cost-sharing agreement, EPA will not suspend the
second firm’s reqistration.
—14—
-------
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.
—15—
-------
TABLE A
GE2 ERIC EW1 REDUIR74 1s FOR NA rALAzc4 wrALAM SODI( 4
I es EPA Have Data
To Satisfy This
Must Additional
Requiraient? (Yes,
Data Requirerrent CcxipcsitionV. 2 / Pb or Partially)
Bibliographic
Citation
Data Be &ibmitted
Under FIE’RA Section
3(c) (2) tB)? 3
§158.120 Product Chanistry
Product Identity :
61—1 — Identity of Ingredients I AI Yes 00106268 No
00106316
61—2 — Description of Beginning AI Partially 00106268 Yes 4 !
Materials and Marufacturing 00106316
Process
L 61-3 — Discussion of Formation of TGPI No - Yes 5 !
IiTpurities —
Analysis arxl Certification of Ingredients
62-1 — Preliminary Analysis I Ai No Yes 6 !
62—2 — Certification of TGAI No Yes 7 !
Ingredient Limits
62—3 — Analytical Methoth to Verify TGAI No Yes
Certified Limits
Physical and Chemical Characteristics
63—2 — Color TGAI Yes 00029170 No
63—3 — Physical State TGAI Yes 00029170 No
00029183
-------
TA&E A
GENERIC DATh RE UIRF74E IS FOR NAPTAIAM/NAPTAIAM S(])IUM
Does EPA Have Data
Must Additional.
‘lb Satisfy This
Data Be Submitted
Requir nent? (Yes,
Data Requirement Ccxnpositionl-I’ 2 / No or Partially)
Bibliographic
Citation
Under EIFRA Section
3(c)(2)(B)? 3 /
S158.120 Product Chemistry (continued)
63- 4 - Qior ‘IGAI No Yes
63—5 — Melting Point ‘ 113A1 Yes 00029170
00029183
63-6 - Boiling Point ¶IGAI N/A No
63—7 - Density, Belk Density, or
Specific Gravity ‘ IGAI Partially 00029170 Yes 8 ’
63—8 — Solubility ‘IGAI/PAI Yes 00029170 No
63—9 - Vapor Pressure PAl N/A No
63—10 — Dissociation constant ¶IUAI, PAl Yes
63—11 — Octanol/water partition PAl No Yes 9 ’
coeff Ic lent
-------
TABEE A
GENERIC DAT 1 RE UIR MEN IS t )R NAPTALAJ4/NAPTPLLAM SC [ )IUM
t ta Requirement
Canpositlon 1 ’ ,21
Does ‘EPA Have t ta
lb Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
L ta Be Submitted
Under WtFRA Section
3(c) (2) (B)? 3 !
158.120 Product Chemistry
(continued)
Other F quirements :
‘IGAI Yes
00029170
00029170
00029183
Yes ’° ’
No
. 614— 1 — Suthiittal of samples
• Choice
Yes 11 ’
1/ Canposition: IGAI = ‘Ièchnical grade of the active ingredient; PAl = Thire
several test substances determined on a case-by—case basis.
active ingredient.
Choice = Choice of
2/ A n nufacturing-use product (MP) for naptalam has not been r istered.
3/ 1 ta must be sutm 1tted no later than six months after publication of this -
Standard, unless otherwise indicated.
LI/ The manufacturer/registrant must suhoit an updated description of the manufacturing process. .Infornation Is needed
as to whether technical naptalam is produced by a batch or continuous process and details concerning how the
registrant produces end—use naptalam [ e.g. the identity of the intermediate(s) used in producing naptalazn products of
relatively high concentrations (> ca 2 14%)]. Information is also needed on the beginning materials, i.e. the names
and addresses of the suppliers and information available frcin the suppliers concerning the ocinposition of these
materials (e.g. the percentage figures for the reactant(s) and their Impurities). Registrants iru t submit information
as to whether nitrite nitrogen (l O 2 —N) is used in the formulation as a corrosion inhibitor, because of the potential
for the fnrmation of nitrosamines. t ta must be submitted no later than twelve months after publication of this
Standard .
63—12 — pH
63—13 — Stability
IGAI, PAl
Partially
-------
TABFE A
GENERIC DATA R UIflFMEN’IS FOR NAPTALAM/NAPTAIAJ4 SCtIIUM
§158.120 Product Chanistry (continued)
5/ The regisi-rant must submit a discussion concerning impurities present in naptalam sodium. The discussion must
address impurities likely to be present in amounts of 0.1% or more and highly toxic ispurities, including those
of carcinogenic potential (as designated by the Agency) which may be present at 0.1% or less. Such highly
toxic impurities may include (but are not limited to): nitrosamines, 1-naphthylamine, 2-naphthylamine, and the
I droxy derivative of 2-naphthylamine. Data must be submitted no later than twelve months after publication of
this Standard .
6/ Five current production lots of the IGAI must be analyzed for the active ingredient, any impurities >0 1%, and any
highly toxic impurities at <0.1%. The analyses for highly toxic impurities nvst include those dis ssed under 61-3
(Discussion of the Formation of Impurities) and believed to be present. ‘IWo samples fran each lot must be analyzed
shortly after production, two more after three months, and two more after six months. For nitrosamines, methodology
with a sensitivity of 1.0 ppm is needed.
7/ A Statament of Certified Limits as described by the Guidelines is required fran the manufacturer for each
integrated-forniulation-systam product (.IFS-product). For naptalam and the intentionally added ingredients, an upper
and lcMer limit must be certified. For impurities present In amounts >0.1%, and any highly toxic impurities, an
upper limit(s) rrn.ist be certified.
8/ The registrant must submit data on the tamperature at which the specific gravity was determined.
9/ The requirenent of data on the octanol/water partition coefficient is conditional. If the salt dissociates, then
— the data are required.
10/ Data are needed on the pH of naptalam, and on the concentration at which the pH of naptalam sodium was determined.
11/ Samples are required of’ both the ‘IDAI, ca 200g, and the pure analytical grade of sodium naptalain.
-------
TABLE A
GF IERIC I TA RB UIRF iENTS FOR NAFrALAM,fl AFrALAM S0DR I
Data Requirenents
Ccm ositionV
I es EPA Have Data
To Satisfy This
Requiren ent? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c) (2) (B)? 2 !
§158.125 Residue Chenistry
17 1-4 — Nature of Residue (i tabolian)
- Plants
- Livestod’
171-4 — Residue Analytical t thod
PAIRA No
PAIRA No
Yes 3 !
yes 4 !
— Plant residues I’GAI Yes
No 5 !
00015782
00028829
00029180
00029182
00076252
00076255
00089710
00106267
00106284
00106299
GS—0 183—01
—0l83—02
—0 18 3—03
cE—0183—04
GS—0 18 3—05
18 3—06
cs—a 18 3—07
— Aninal Residues
1 I No
-------
TA&.E A
G ERIC E TA REQUIRE 4EmS R R N rALAz4/NApTAL M SODI1 4
Data RQquirenents
Ccii x it ion ’!
I es EPA Have Data
To Satisfy This
Requir nt? (Yes,
No, or Partially)
Bibliographic
citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c) (2) (B)? 2 !
§158.125 1 sidue C nistry (contiruied)
171-4 - Magnitude of the Ièsidue—
Residue Studies for Each
Fbod t e
PAl and No
netabolites
Crc.p Groip 1 - Legtnne Vegetables (sucoilent or dried)
Crcp 1 — Soybeans (including hulls, neal, oil, and soapetock)
Qcp (k oip 2 - Ebliage of Legtwe Vegetables Groip
Crcp 1 - Soybean Forage and Hay
—— Crc field trials
TEP
Partially
00031797 00106293
00106269 00108307
00106284
Yes 9 !
171—4 — Storage Stability Data
—— Crcp field trials
Yes 7 !
No 8 !
00024512
00089708
00106315
00029325
00094846
00106319
00030995
00106269
00106393
00031797
00106274
00108307
00106284
00108871
-------
TABLE A
G ERIC IY TA REX UIRE 4EP ’rS DR NA rALAM’NAI rAIAM SODIUM
Data R.equirei ent
Ccirç ition 1 /
I es EPA Have Data
To Satisfy This
Requir nent? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c) (2) (B)? 2 !
§158.125 Residue th uistry (continued)
Crcp Graip 3 - Cucurbit Vegetables ( oip
Crop 1 - Cucumbers
Crop 2 - Cantalcupes
—— Crop field trials
crop 3 — ternelons
—— Crop field trials
crop 4 — t4iskne lons
—— Crop field trials
00106269
00106284
00108308
00106269
00106284
00108308
00106269
00106284
00108308
00106269
00106284
00108308
—— Crop field trials
TFP
TEP
TEP
Partially
Partially
Partially
Partially
Yes’ 0 ’
Yes’ 1 !
Yes’ 2/
Yes’ 3/
-------
TABLE A
GENERIC 1 TA RE )UIRENENTS FOR NAFFALAM/ AFrALAM SODIUM
I es EPA Have Data
Must Additional
To Satisfy This
Data Be Submitted
Data Requirenent
Ccx position’/
Requir ient? (Yes, Bibliographic
Pb or Partially) Citation
Under FIFRA Section
3(c)(2)(B)? 2 /
§158.125 Residue Chen istry (continued)
Crcp Group 4 - Snail Fruits and
Berries &cup
Cr 1 - Cranberries
—— Crcp field trials
TEP
Yes 00106269 GS—0183—09
00106284 GS—0183—l0
No 8 1
Miscellaneous Camiodities
—— Peanuts (includir neal,
oil, and soapetock)
TFP
Yes 00031793 00106290
00106041 GS—0183—ll
00106269 Gs—0183—09
NO 8 !
—— Peanut Hulls
TEP
Yes 00106041 00106290
00106269 CS—0183—14
00106284 GS—0183 —15
No 8 !
—— Peanut Fbrage and Hay
TEP
Partially 00031793 00106269
00106041 00106284
Yes
Meat/milk/poultry/eggs
TFP and
N/A -
No 14 /
1/ -
netabolites
the active
ingredient; PAIRA = Pure active ii redient,
radiolabelled; TEP =
Cat osition: 1’GAI = Technical grade of
1 ’pical end-use product; EP = E d-use product.
,/ Data nust be submitted no later than twenty-four nvnths after publication of this Standard , unless otherwise
indicated.
-------
1 TA TABFE A
GENERIC DATA R UIRE1 lEW1 FOR NAPTALAM/NP.PTAIAM S(])ItJM
§158.125 J sidue Chemistry (continued)
3/ The registrants can fill this data gap in one of two ways, either by using two 1’ C_naptalam studies, one with the
ring-labeled phthalic acid moiety and the other with a 1 4 C_labe l in the l—naphthylaznine moiety (Isolation and
identificution of metabolites fran mature plant tissues must follow), or by using a double-labeled test material. At
least soybeans and a cucurbit must be tested.
It! t .ta on rat, ruminant, arxi poultry metabolism (metabolites) are required unless the registrant can show that there
are no detectable residues in animal feeds by a sensitive method, or that practical restrictions can be Imposed on
the use of naptalam which will preclude fran an:linal feeds detectable residues of concern.
5/ Additional methodology may be required if metabolites of concern are identified In plant tissues.
6/ Additional methodology may be required If residues of concern are Identified in animals based on the requested animal
metabolism studies, but only if tolerances in meat, milk, or eggs and/or feeding studies are required.
7/ The registrant must submit data that show the storage stability of residue samples subjected to the same conditions
under which the residue samples collected by the registrant have been stored.
8/ Additional residue data may be requl.red If the requested plant metabolism studies reveal additional residues of
concern.
9/ The registrant must su nlt data on the residues in soybean forage.
10/ A preemergence treatment with an FXJ, G, or SC/L must be made at 6 lb al/A followed one month after seeding (or
before vine formation) by a postemergence treatment with an or SC/L at II lb al/A. Aerial arid graind-applied
postemergence treatments are required. All residues of concern identified in the requested plant metabolism
st .idies must be determined. Studies must be conducted in CA, FL, NC, TX, MI, NY, and WA.
11/ Same as cucuithers (footnote 10) except that tests must be conducted in either CA and 1 1N, or MI, GA, TX, and AZ.
12/ Same as cucunbers (footnote 10) except that test sites must be In CA, FL, TX, SC, and MD.
13/ t ta for cantalaipes, cucumbers, and watermelons will be translated to muskmelons.
114/ No tolerances for naptalam residues in animal products have yet been established because no detectable residues were
expected in or on feed items.
-------
TA E A
GF ERIC EYTA RkOUIR 4EN1’S FOR N FrALAM/NAFrALAM SODIUM
Does EPA Have Data
TO Satisfy This
Must Additional
Data Be Submitted
Use
Data I equire ent conpc ition 1 / Pattern 2 !
Requir nent? (Yes,
No or Partially)
Bibliographic
Citation
Under FIFRA Section
3(c)(2)(B)? 3 /
§158.130 Envirorinental Fate
CfX3R1 DATION STUDIES—tM:
161—1 — Hydrolysis
Photodegradat ion
161—2 — In water
16 1—3 — c soil
161—4 — In air
METABOLISM STIJDI ES-US:
162—1 — Mrobic Soil
162—2 — Anaerobic Soil
16 2—3 — Anaerobic k uatic
162—4 — Mrobic kluatic
I I
or
PAIRA
A,B,C,G
No
Yes 4 !
1GM
1GM
or
or
PAIRA
PAIRA
A,B,C,G
A,G
No
No
Yes 4 !
Yes 4 !
TGAI
or
PAIRA
N/A 5 !
No
1 I
or
PAIRA
A,B
No
Yes 6 !
TGAI
TGAI
or
or
PAIRA
PAIRA
N/A 7 !
C,G
No
No
No
Yes 6 ’
TGAI
or
PAIRA
C
No
Yes 8 !
-------
TABLE A
G IERIC E TA R QUIRil4ENTS FOR NA rAMM,41wrAL M SODI(14
Ibes EPA Have Data
To Satisfy This
Must Mditional
Data Be Submitted
Use
Data Require ient Ccnçc ition 1 / Pattern 2 !
Raquira nt? (Yes,
or Partially)
Bibliographic
Citation
Under FIFRA Section
3(c)(2)(B)? 3 /
5158.130 Envirorinental Fate
(contirued)
)BI LIT! STUDIES :
163-1 — Leaching and TGAII or PAIRA A,B,C,G Pb Yes 4 !
AdsorptiorVDesorption 1 AI or PAIRA C,G No Yes 4 !
163—2 — Volatility (Lab) TEP N/A 5 !
163—3 — Volatility (Field) TEP N/A 5 ! No
DISSIPATION STUDIES-FIELD :
164-1 — Soil TEP A,B No Yes 6 !
164—2 — uatic (Sediment) TEP C No Yes 9 !
(b ter) TEP C No
164-3 - Forestry TEP N/A ’ 0 ! No
164—4 — Ccxnbination and
Tank Mixes N/A 11 ! - No
164—5 — Soil, long-tern 1 servedW -
-------
TABLE A
GF ERIC DATA RB UIR 4FN1S OR N rALAM/NAFrALAM SODI1 i
Data Require rent
CcxI x]sition 1 /
I es EPA Have Data
To Satisfy This
Use Requira nt? (Yes,
Pattern 2 ’ No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? 3 /
§158.130 Enviromental Fate
ACQJM(JLPTION STUDIFS:
165—1 - Rotational Crcps
(Q nfined)
PAIRA
A,C No
-
Yes 6 ’
165-2 - Rotational Crops
(Field)
TEP
I served 13 / —
-
-
165-3 - Irrigated Crcps
TEP
N/A / —
—
No
165—4 - In Fish
1 I or PAIRA
A,B,C
No
—
Yes
165-5 - In Aquatic
Non-Target
TEP
C’ /
No
-
Yes
Organ
§158.140 Reentry Protection
TEP
N/A /
—
-
No
J Caiçosition: TG I = Technical grade of the active ir redient; PAIRA = Pure active ir redient, radiolabelled;
TEP = 1 ’pical end-use product.
J The use patterns are xxled as follcMs: A = Terrestrial, Food Crop; B = Terrestrial, Non—Food; C = Aquatic, Food
Crop; D = Aquatic, Non—Food; E = (keenhaise, Food Crop; F = çreenhciise, Non—Food; G = Forestry; H = [ )vestic:
Outdoor; I = Indoor
-------
T LE A
G ERIC E TA RFOUIRE 4 2lTS R R NA FALAM,4IAPTALAM SODIIII
Sl58.130 &ivironnantal Fate
(contirlied)
/ Unless otherwise indicated, data nust be submitted no later than six months after publication of this Standard .
/ These data have been required under a data call—in progr . The data nust be sutinitted no later than nine months
after receipt of the data call—in notice , r* ith was nailed October 31, 1984.
/ No data are required because of use pattern and low vapor pressure (volatility) of naptalan sodiun salt.
/ These data have been required under a data call—in progran. The data nust be submitted no later than two years after
the receipt of the data call—in notice , which was nailed October 31, 1984.
2! Anaerobic aquatic replaces anaerobic soil — anaerobic aquatic required.
Data nust be submitted no later than twenty-four months after publication of this Standard .
j These data have been required under a data call—in progran.- The data nust be submitted no later than two years’ after
receipt of the data call—in notice, which was nailed Oc*ober 31, 1984.
No forestry use.
Registration Standarde do not address ccinbinations and tank mixes in most cases.
If 50% dissipation reached by time of subsequent (label) application, no long—term study required. (based on aerobic
soil netaboli n or field s iddipation studies.) If data are required, they mist be submitted no later than thr€e years
after publication of this Standard .
13/ Required if significant residue(s) of concern are detected in the confined study.
4/ b ter used to flood cranberries is not utilized for other cr s.
( Cranberry use has aquatic Iiipact; direct discharge into water accessible to wildlife, birde, fish or aquatic
organi s.
j / Re-entry not triggered by this pesticide.
-------
TABLE A
GENERIC EWFA RB)UIRENE I1S FOR NAFrALAI.t/NAPTALAM SOOI 1i
Ibes EPA Have Data
To Satisfy This
Must Mditional
Data Be Sub nitted
Use
Data Requiren nt Ccii oeition 1 / Patterns 2 !
Requir nent? (Yes,
No or Partially)
Bibliographic
Citation
Under FIFRA Section
3(c)(2)(B)? 3 /
§158.135 Toxiology
ACUI’E TESTING :
81—1 — Oral Toxicity — Rat TGAI A,B Yes 00029172 No
00076205
81—2 — Dermal ¶lbxicity IXAI A,B No Yes
81-3 — Inhalation Toxicity — Rat TGAI A,B No Yes
81-7 - Acute Delayed 1 AI N/A N/A No 4 !
Neurotoxicity — Ibn —
SUBCH1 )NIC TESTING :
82—1 — 90—Day Feeding —
Rodent l AI A No Yes 5 !
Non-rodent 1 M A No Yes 5/
82-2 - 21-Day Dennal 1 I N/A No Reserved 6 !
82-3 - 90-Day Dernu 1 1 I N/A No Reserved 6 !
82—4 — 90—Day Inhalation — 1 3AI N/A No; Reserved 6 !
Pat
82-5 — 90-Day Neurotoxicity- L I N/A No No 4 /
HerVMai ma 1
-------
Toxicology (cent inued)
iI JNIC TESTING :
83—1 — thronic Toxicity —
2 species: } dent
and Non-rodent
83—2 — Oncogenicity St 1y —
2 species: Rat and
Mouse preferred
83—3 — Teratogenicity —
2 species
83—4 — Reprodiction —
2—generation
MUrNENIcITY TESTING
84-2 - Gene Mutation
84—2 — (hrat sc*na1 Pberration
84-2 - Other thani of
Ptatagenicity
TABLE A
GENERIC DATA RET JIRR€N’IS FOR NAPrAI4’F J JI SODIEJI
EPA Have Data
To
Must Additional
Data
Require ent
Cci osition 1 /
Use
Patterns 2 !
Satisfy This
Requir nent? (Yes,
No or Partially)
Bibliographic
Citation
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? 3 /
S158.135
I
A
No
-
Yes 5 !
TGAI
A
Partially
GS—0183-15
Yes 7 !
TGAI
d
A,B
Partially
00106320
Yes 8 !
1 I
A,B
No
-
Yes 9 !
1 I
A,B
Partially
00072153
Yes ’ 0 /
1 AI
A,B
No
Yes ’ 1 !
TG I
-------
ThB E A
GENERIC DA RFQUIRE?4EWI FOR NAPT UAM/NAPTALAM SG)ItR4
D0e8 ‘EPA Have Data
lib Satisfy This
Must Additional
Data Be
Data Requir ent
Canpoeltion 1 /
Use
Pattern 2 !
Requir nent? (Yes,
No or Partially)
Bibliographic
Citation
Under I IFRA Section
3(c)(2)(B)?
§158.135 ¶Ibxicology
(continued)
SPECIAL LT! tJ:
85-1 - General Metaboli
PAl or PAIRA
A
No
-
1/ Canpositlon: ¶IUAI = technical grade of the active ingredient; PA l = Pure active ingredient; PAIRA = Pure active
ingredient, radiolabeled; Choice = Choice of several test substances determined on a case—by-case basis.
2/ PossIble use patterns are coded as follows: A = rrestrial, Food Crop; B = ‘Iërrestrial, Non-Food; C = Aquatic, Food
Crop; D = Aquatic, Non-Food; 1 E = Greenhouse, Non-Food; G = Forestry; H = Don stIc C itdoor; .1 = Indoor.
3/ Unless otherwise specified, data must be submitted no later than six months after the publication of this Standard .
11/ Data are not required.
5/ Data are required for a rodent (preferably the rat) and a non—rodent (preferably the dog) species. Data must be
submitted no later than twelve months after publication of this Standard .
6/ RequIr nent is contingent upon the outcane of the worker exposure analysis, If needed.
7/ The listed study fulfills part of the data requir nent, because it is a valid stidy using mice. A second study using
another species (preferably the rat) Is required. These data were required under a data call-In notice nRIled
October 31, 19811. Data must be sut nitted no later than four years after receipt of that notice.
8/ The listed study fulfills part of the data requlrønent, because it Is a valid st y using rats. A second study using
rabbits, is required. These data were required under a data call-in notice rt iled October 31, 19814. These data rrust
submitted no later than twenty—six months after receipt of that notice.
9/ Data must be submitted no later than twenty-two months after the publication of this Standard .
-------
TABLE A
GENERIC E TA REX)4JIRE74EWrS )R NA rALAM41AprM AM SODWI
§158.135 lbxicxilogy
(continued)
j / Testing is required in manunalian cells (mouse L thcma L5178Y; or CHO, HGPRT loois). Data nust be submitted no later
than ten months after publication of this Standard .
jjJ Testing is required in an in vitro systan (SCE in CHO cells or cells or other manmialian cell lines); and in an in vivo
systan (dminant lethal test in rodents). Data nust be submitted no later than ten months after the publication of
this Standard .
/ Testing is required for DN repair in mammalian cells. Data nust be submitted no later than ten months after the
publication of this Standard .
-------
TABLE A
GENERIC DATA ROUIRE 4ENTS FOR N rALN4/NM rALAM SODI1 4
Does EPA Have Data
lb Satisfy This
Must Additional
Data Be Submitted
Use
Data Requireflent ca çoeition 1 / Pattern 2 !
Raquir i nt? (Yes,
No or Partially)
Bibliographic
Citation
Under FIFRA Section
3(c)(2) (B)? 3 !
§158.145 Wildlife arid Aquatic Organians
AVIAN AND MN’QIALIAN TE ING
71—1 — Avian Aaite Oral Toxicity TGAI A,B Yes GS-0183—16 No
71—2 — Avian Dietary lbxicity TGAI
a) Waterfc il A,B Yes 00108853 No
b) Upland Gama Bird A,B Yes 00082969 No
71—3 — Wild Mammal Toxicity I A I N/A
71—4 - Avian ReprcxkictiOfl ‘1 AI A NO Reserved 4 !
71—5 — Simulated and Actual Field TEP A,B No No
Testing - Mamma .ls and Bi r
? JJATIC OWANISM TESTING
72—1 — A ite Toxicity to
Freshwater Fish TGAI
a) Warnwiater Species A,B Yes 00070193 No
00024161 !
b) coidwater ecies A,B Yes 00070193 No
72—2 — Aaite Toxicity to
Frest iater Invertebrates TGAI AB Yes’. 00082971 No
72—3 — Aaite lbxicity to
Fatuarine and Marine
Organiais TGAI
a) Shrinp A 6 ! No Reserved 4 ’
b) Marine fish A / No peserved /
c) C ’ster A / No Reserved 4 !
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TA& E A
GENERIC I TA REOUIRF}IENTS R)R NAPTAL M,’NM’rALAM SODILI4
[ es EPA Have Data
lb Satisfy This
Must Additional
Data Be Submitted
lisa
Data Require rent Cci1 ositionV Pattern 2 !
Requir nt? (Yes,
No, or Partially)
Bibliographic
Citation
Under FIFRA Section
3(c)(2)(B)? 3 /
§158.155 Nontarget Insect
NONTAI 3E INSECT TESTING —
Pollinators:
141—1 — Honey bee aoIte l AI A,B Yes 00028772 No
contact toxicity
141—2 — Honey bee toxicity of TEP A,B No No 4 !
residues on foliage —
141-4 - Honey bee subaa.ite Reserved 5 !
feeding study
141—5 — Field testing for TEP AB No No 4 !
pollinators
NrAIGg1’ INSECT TESTING - ACUATIC INSECTS :
14 2—1 — Acute toxicity to Reserved 6 !
a uatic insects
142-2 — Aquatic insect Reserved 6 !
1ife—c c1e study
142—3 — Simulated or actual Reserved 6 ’
field testing for
aquatic insects
143-1— NO A1 ET INSEX F TESTING Reserved 6 !
143-3 PREDNIORS AND PARASITES
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TABLE A
GENERIC D Th R QUIRENENTS F )R NAPrALAM,44APTALAM SODIL 4
S158.155 Non—target Insect 1 ta
(continued)
Catposition: l I = Technical grade of the active ingredient; TEP = Typical end-use product.
The use pattern oodes are as foliQis: A Terrestrial, Fbod Crap; B= Terrestrial, Non-Food; C= Aquatic, Food Crap;
1 Aquatic, Non-Fbod; E eenhc*ise, Food Crap; FGreenhcuse, Non—FOod; G=Forestry; H=D estic (Xitdoor; I=Indoor.
Data nust be submitted no later than 8ix ircnths after publication of this Standard , unless otherwise indicated.
As data fran the aaite study indicate l toxicity to bees, no further testing is required.
Requiraient reserved pending Agency develcp nt of test metlx)doloQJ.
Reserved pending Agency decision as to whether the data requirai nt shczild be established.
-------
III. SUBMISSION OF RFVISED LABELING
Note : This section applies to end use products only to the
extent described in Section I (Requlatory Position and
Rationale). Otherwise, the followina information pertains
exclusively to manufacturing use products.
FIFRA recuires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflectina
the results of data concerning the product and its ingredients.
Labeling requirements are set out in 40 CFR 162.10 (see
Appendix IV—l) and are summarized for products containina
this active ingredient as part of this Guidance Document
(See A endix IV-2). Applications submitted in resoonse to
this notice must include draft labelinq for Aaency review.
If you fail to submit revised lahelina information
complying with this section (supplemented by requirements
described in Section I, Regulatory Position and Rationale),
EPA may issue a notice of intent to cancel the reqistration
under FIFRA sec. 6(b)(l).
A. Label Contents
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labe1in . Specific label items
listed below are keyed to Appendix IV-2.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accented if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributdr is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the comoany 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 l() ounces” rather than
“26 ounces.” In addition to English units, net contents may
be expressed in metric units. See Appendix IV—l. 4fl CFR
162.10(d)]
—37—
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Item 4. EPA REGISTRATION NUMBER - The registration
number assiqned to the pesticide product must appear on the
label, preceded by the phrase “EPA Registration No.,” or “EPA
Reg. No.” The registration number must be set in type of a
size and style similar to other print on that Part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suqqest or imply recommendation
or endorsement of the oroduct by the Agency. See Apoendix P 1-i.
(40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase “EPA Est.” is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wraooer or outside container of
the packaqe if the EPA establishment number on the immediate
container cannot be clearly read throuqh such wrapper or container.
See Appendix IV—1. [ 40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT — An inqredients statement
is required on the front panel. The inqredients statement must
contain the name and percentaqe by weight of each active inqredient
and the total percentaqe by weiqht of all inert ingredients.
The oreferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinqujshed from, other text on the panel. It must not be
placed in the body of other text. See Appendix IV—1. [ 40 CFR
162.10(g)]
Item 68. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
Precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word “Keep Out of Reach
on Front Panel Minimum Type Size of Chi1dr n”
in Square Inches All Caoitals 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 ooint 10 point
over 30 l point 12 point
—38—
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Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
“Keep Out of Reach of Children” must be located on the front
panel above the signal word exceøt where contact with children
during distribution or use is unlikely. See Appendix IV—l.
[ 40 CFR 162.l0(h)(l)(ii)J
Item 78. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warninq statement. See Appendix IV—l.
[ 4OCFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSRONES AND WORD “POISON” - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word “Poison” shall appear on the
label in red on a background of distinctly contrastinq color and
the skull and crossbones shall aooear in immediate proximity to
the word POISON. See Appendix IV—l. 40 C ’R l62.lr)(h)(1)(i)J
Item 70. STA’PEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity rateqories I,
II, and III. See Appendix IV—1. F40 CFR 162.1fl(h)(l)(iii)]
Item 7E. REFERRAL STATEMENT - The statement “See Side
(or Back) Panel for Additional Precautionary Statements” is
required on the front panel for all products, unless all
reauired precautionary statements appear on the front panel.
See Apoendix IV—1. [ 40 CFR 162.l0(h)(l)(iii)1
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear toqether
on the label under the headina “PRECAUTIONARY STATEMENTS.”
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is oreferred
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 Aopendix IV—l. [ 40 CFR 162.10
(h)(2)j
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, orecautionary
statements are recuired indicatina the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, iniury or damaae. See Appendix IV-l. [ dO CF’R l 7.l0
(h) (2) ( i)]
-------
Item RB. ENVIRONMENTAL HAZARD - Where a hazard exists to
non—target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, iniury, or damage. See Appendix iV—1. [ 40 CFR
162.10(h) (2) (ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammability statement . Precautionary statements relating
to flammability of a product are required to appear on the
label if it meets the criteria in Appendix IV—3. The require-
ment is based on the results of the flashpoint determinations
and flame extension tests required to be submitted for all
products. These statements are to be located in the side/hack
panel precautionary statements section, preceded by the
heading “Physical/Chemical Hazards.” Note that no signal.
word is used in coniunction with the flammability statements.
2. Criteria for declaration of non—flammability . The
following criteria will he used to determine if a product
is non—flammable:
a. A “non—flammable gas” is a qas (or mixture of gases)
that will not ignite when a lighted match is placed
aqainst 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. The flame extension is zero inches:
ii. There is no flashback; and
iii. The flashpoint of the non—volatile liquid
component is greater than 350°F (177°C).
3. Declaration of non—flammability . Products which
meet the criteria for non—flammability specified
above may bear the notation “non—flammable” or “non-
flammable (gas, liquid, etc.)” on the label. It may
appear as a substatement to the ingredients statement,
or on a back or side panel, but shall not be highlighted
or emphasized (as with an inordinately large type
size) in any way that may detract from precaution.
—40—
-------
4. Other physical/chemical hazard statements . When
chemistry data demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such statements
may address hazards of explosivity, oxidizing or reducing
capability, or mixing with other substances to produce
toxic fumes.
Item C. MISuSE STATEMENT — All products must bear the
misuse statement, “It is a violation of. Federal law to use
this product in a manner inconsistent with its labeling.”
This statement appears at the beqinning Øf the directions
for use, directly beneath the heading of that section.
Item bC. STORAGE AND DIqPOSAr BLOCK - All labels are
required to bear storage and disposal statements. These
statements are develooed for specific coiitainers, sizes, and
chemical content. These instructions must be qrouoed and
appear under the heading “Storage and Disposal” lfl the directions
for use. This headinq must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix
IV—4 to determine the disposal instructions appropriate for
your products.
Item 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 iniury and to
prevent unreasonable adverse effects on the environment. See
Appendix iV—l. [ 40 CFR 162.10]
B. Collateral Labeling
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other graphic printed matter which is referred to
on the label or which is to accompany the product are termed
collateral labelina. Such labeling may not hear claims or
representations that differ in substance from those accepted
in connection with reqistration of the product. It should be
made part of the response to this notice and submitted for
review.
—41—
-------
IV. INSTRUCTIONS FOR SUBMISSIflN
All applications prepared in response to this Notice should
be addressed as follows:
Robert Taylor, Product Manager
ReqistratiOn Division (TS-767C)
Office of pesticide proqrams
Environmental Protection Agency
Washington, D.C. 204 0
Phone No. (703) 557—1650
A. For Manufacturing products (MP) containing (name of
pesticide) as an active ingredient .
1. Within 90 days from receipt of this document, you must
submit the “FIFRA Section 3(c)(2)(B) Summary Sheet” EPA Form
8580—1. Refer to Appendix 11—3 with appropriate attachments.
2. Within 6 months from receipt of this document you must
submit:
a. Confidential Statement of Formula, EPA Form 8570—4.
b. Product Specific Data Report, EPA Form 8580-4
(Appendix 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 labelinq must comply specifically with the instructions
in Section i (Regulatory Position and Rationale) of this
guidance document. The labelinq should be either typewritten
text on 8—1/2 x 11 inch paper or a mockup of the labelina
suitable for storage in R—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 suøport reauirements
of FIFRA sec. 3(c)(l)(D). Refer to PR Notice 84—4 (enclosed)
for latest requirements.
3. Within the times set forth in Table A , all qeneric data
must be submitted.
Note : If for any reason any required test is delayed or
aborted so that the agreed schedule cannot be met, notify
the Product Manager.
—42—
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B. For Manufacturing Use Products containing (name of pesticide)
in combination with other active ingredients
1. Within 90 days from receipt of this document, you must
submit the “FIFRA Section 3(c)(2)(B) Summary Sheet,” EPA Form
8580—1. Refer to Appendix 11—3 with apPropriate attachments.
2. Within the times set forth in Table A , all generic data
must be submitted .
Note: If for any reason any required test is delayed or
aborted so that the agreed schedule cannot be met, notify
the Product Manager.
C. For End Use Products containing (name of pesticide) alone
or in combination with other active inaredients:
1. Within 90 days from receipt of this document, you must
submit the “FIFRA Section 3(c)(2)(B) Summary Sheet,” EPA Form
8580—1. Refer to Appendix 11—3 with appropriate attachments.
2. Within 6 months from receipt of this document you must
s u bm i t:
a. Confidential Statement of Formula, EPA Form 5570-4.
b. Product-Specific Data Report, EPA Form 8580-4
(Appendix III—!).
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 submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. Labelinq should be either typewritten
text on 8 1/2 x 11 inch paper or a mockup of the labeling
suitable for storaqe in 5 1/2 inch files. The draft label
must indicate the intended colors of the final label, clear
indication of the front panel label, and the intended type
sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(l)(D). Refer to PR Notice 54-4 (enclosed)
for latest requirements.
3. For those end use product registration that are not
eligible for the formulator’s exemption, submit all generic data
within the time set forth in Table A.
D. For intrastate products containinq (name of pesticide)
either as the sole active ingredient or in combination
with other active ingredients
—43—
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Appendix I l-i
Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arrivinq at the oositions 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 suoport of past regulatory
decisions. Selections from other sources including the
published ]iterature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a “study.” In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
“studies” generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by “Master Record Identifier,” or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six—dicit “Accession Number”
which has been used to identify volumes of submitted
studies: see paragraph 4(d)(4) below for a further explana—
tion. In a few cases, entries added to the biblioaraphy
late in the review may be preceded by a nine—character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consiStS of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. BibliograPhic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
—44—
-------
Appendix IT—i (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 Aqency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Aaency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Aqency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographerS to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailina parentheses. For studies submitted to the
Agency in the past, the trailinq parentheses include
(in addition to any self—explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
“received.”
(2) Administrative Number. The next element,
immediately following the word “under,” is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase “submitted by.” When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailinq 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 l234 6, the
first study would be l23456—A the second, 123456—
B: the 26th, 123456—Z; and the 27th, 123456—AA.
—45—
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APPE IX 11—2
OFRICE OF PESTICIDE PROGRAMS
IS IRA ON ST .NDAFJ) BIBLIOGRAPHY
Citations Considered to be Part of the L ta Base Supporting
Registrations Under the Naptalam/Naptalam Sodium Standard
00015776 Rolla, H.M.; Pvieedy, B.G. (1978) Residues of Metolachior, Naptalarn
arid Dlno8eb in or on Soybeans Resulting fran Thnk Mix Applica-
tions: Report No. ABR—78 059. Sumary of studies 237822—B
through 237822- E. (Unpublished study received Mar 16, 1979 Wi-
der 100-583; submItted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL: 237822—A)
00015781 Hormby, P.; Kahrs, R.A. (1978) Report: Residue Analysis of Soybean
arid Soil for Dyanap: PL No. 8PL-2-3. (Unpublished study re-
ceived Mar 16, 1979 Wider 100—583; prepared by Blospherics,
Inc., st*in tted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
237822—F)
00015782 Lane, J.R. (1970) Alanap(R): General Residue Method. Method dat-
ed Dec 1, 1970. (UnpublIshed study received Mar 16, 1979 under
100-583; prepared by Uniroyal, .Inc., submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:237822-G)
00024161 McCann, J.A. (1968) Sodium A].ariap: fl xicity to Bluegill: at
No. 133. (U.S. Agricultural Research Service, Pesticides Regu—
lat ion Div., Animal Biology Laboratory, unpublished report.)
00024512 Morse Laboratories (1972) Analysis of Soybeans for Residues of
Various Ccinponenta of Dyanap and Lasso. (Unpublished study re-
ceived Nov 15, 1972 under 400—75; submitted by Uniroyal Chemi-
cal, Bethany, Corin.; CDL:003251-IE)
00028772 AtId.na, ‘E.L.; Greywood, ‘E.A.; Macdonald, R.L. (1973) ‘Ibxicity of
Pesticides arid Other Agricultural C nicals to Honey Bees: Labo-
ratory Studies. Rev. By Univ. of California—Riverside, Dept.
of ‘ itanology. Riverside, Calif.: UC, Agricultural ‘&tens Ion
Service. (Also in unpublished subml8sion received Apr 2, 1980
under 464-556; submitted by I w Chemical U.S.A., Midland, Mich.;
CDL: 242149—Z)
—46—
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00028829 Lane, J.R. (1968) Det rmiflatiOfl of 0.1 P 1 Alanap Residues in
Crcps. (Unpublished study received Jan 25, 1972 under 476—2004;
prepared by tinir ja1, Inc., submitted by Stauffer Ch nica1 Co.,
Rictirofld, Calif.; a)L:003867—M)
00029170 United States Rubber Carçar J (19??) Alanap(R). Naugatuck,
Conn.: U.S. Rubber. (Also in unpublished submission received
Dec 12, 1967 under 400—49; CDL:009021—A)
00029172 Food Research Laboratories, Incorporated (1952) Aoite oral Toxicity
of the Sodiun Salt of NaphthylphthalaTtic acid. (Unpublished
study received Dec 12, 1967 under 400—49; submitted by Uniroyal
Ch nical, Bethar y , Conn.; CDL:009021—C)
00029180 Lane, J.R. (1964) Detenninatiofl of 0.1 PR Alanap Residues in
Crcps. Undated n thod. (Unpublished study received Dec 12,
1967 under 400—49; submitted by Uniroyal themical, Bethany,
Conn.; CDL:009021M)
00029182 Lane, J.R. (1967) The Effects of F Tolerance Pesticides on the
Detection and covery of Alanap Residues in Various Crcps. In-
cludes undated iTethod. (Unpublished study received Dec ) 2, 1967
under 400—49; submitted by Uniroyal themical, Bethany, Corin.;
DL:00902iO)
00029183 Fe1dyT fl, A.W.; ReynoldS, P.M., coup. (19??) A Technical Surnrr ry on
Alanap, a Pre—energenCe Herbicide and Grci th Regulant. Nauga—
tuck, Conn.: United States Rubber. (Alanap sunn ry no. 6B; also
in unpublished subMiSsiOn received Dec 12, 1967 under 400—49;
submitted by Unircyyal Chenical, Bethany, Cortn.; CDL:009021—P)
00029325 Uniroyal themical (1975) SuTnhiary of Residue Data. (Unpublished
study received Mar 28, 1975 under 400—75; prepared in co era
tion with ?brse Laboratories, Inc. and others; L:028433—B)
00030995 Lane, J.R. (1974) Residue Surnulary. (Unpublished study received Mar
20, 1974 under 400—85; prepared in cocperatiofl with State Univ.
of N York—-OsWegO, Lake Ontario Envirorinental Laboratory,
submitted by Uniroyal themical, Betharty, Ccnn.; CDL:023356B)
00031793 Gib , W.C.; Shrader, J.W.; BristO , J.R.; et al. (1976) Si zt ry
of Residue Data for the sequential AppliCatiOn of Vernarn -r
Dyanap on Peanuts. (Unpublished study received Aug 11, 1976
under 476—2155; prepared in coc eration with ! rse Laboratories,
Inc., submitted by Staffer Chenical Co., RiC muofld, Calif.;
a L: 22543 1—D)
-47-
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00031797 Loroetg, J.; Lcirberg, J.; Willrett, J.; et al. (1976) Summary of
Residue t ta for the S juentia1 Application of Vernam + Dyanap
on Soybeans. (Unpublished study received Aug 11, 1976 under
476—2155; prepared in cocperatiori with rse Laboratories, Inc.,
submitted by Stauffer Chanical Co., Richmond, Calif.; CDL:
225431—H)
00069134 Uniroyal Ch nica1 (1977) S .niu ry of Residue Data Post— TerQenCe
Overtop Split Application on Spybeans. (ConpilatiOrk; unpub-
lished study received Jun 20, 1977 under 400—75; CDL:230744-A)
.00069142 Uniroyal themical (1978) Alanap 1203 Residue themistry. (Cam-
pilation; unpublished study received Mar 27, 1978 under 400—49;
CDL: 233386—A)
00070193 Kuc, W.J. (1977) Acute Toxicity of Alanap Technical, Lot BL8190
(C—465) to the Bluegill Sunfish, Lepanis jt crochirus Rafinesque
and Rainb Trc* t, Sairro gairdneri Richardson: UCES Proj. *
11506-29—05. (Unpublished study received Nov 30, 1977 under
400—49; prepared by Union Carbide Corp., submitted by Uniroyal
themical, Bethany, Conn.; CDL:232477—D)
00072153 Jagannath, D.R. (1978) Mutagenicity Evaluation of lanap Techni-
cal in the Anes Sali onella/MicrOSafle Plate Test: LB Project
No. 20988. Final rept. (Unpublished study received Mar 8,
1979 under 400—49; prepared by Litton BionetiCs, Inc., sub-
mitted by Uniroyal themical, Bethany, Conn.; CDL:23778l-A)
00076205 Food Research Laboratories, incorporated (1952) Acute Oral Toxic-
ity Study of Naphthylphthalamic Acid: Laboratory No. 63361,
(Unpublished study received on unknom date under 400-42; sub-
mitted by Uniroyal themical, Bethany, Conn.; CDL:l03011—A)
00076252 Smith, A.E.; Stone, G.M. (1953) Microdete ninatiOfl of N—l—naph—
thylphthalarniC acid residues in plant tissues. Analytical them—
istry 25(9):l397—1399. (Also in unpublished submission received
Oct 12, 1955 under 400—42; submitted by Uniroyal themical,
Bethany, Conn.; CDL:231167—C)
00076255 Smith, A.E.; Stone, G.M. (1952) The MicrodetermiflatiOn of N—1—Naph—
tny1phthal nic Acid Residues. Undated nethod. (Unpublished
study received Nov 3, 1952 under 400—42; submitted by Uniroyal
Chenical, Bethany, Conn.; CDL:231167—F)
-48-
-------
00082969 Fink, R.; Beavers, LB. (1977) Final Report: Eight—day Dietary
LC5O——Bob 1 Qhite Q.iail: Project No. 117—122. (Unpublished study
received Nov 30, 1977 under 400—49; prepared by Wildlife In-
ternational, Ltd., submitted by Uniroyal (iiemical, Bethany,
Conn.; CDL:232477—B)
00082971 Vilkas, A.G. (1977) The Acute Toxicity of Alanap Technical Lot
BL 8190 to the ? ter Flea, Daphnia magna Straus: (LES
Proj. * 11506—29—08. (Unpublished study received Nov 30, 1977
under 400-4 9; prepared by Union Carbide Corp., submitted by
Uniroyal Ch nical, Bethany, Conn.; CDL:232477—E)
00389708 Elanco Products Conpany (1973) Soybearis——Surflan Plus Dyanap.
(Ca pi1ation; unpublished study received Nov 19, 1974 under
1471—96; CDL:101691—A)
00089710 Lane, J.R. (1970) Alanap(R): General Residue Method. Method
dated Dec 1, 1970. (Unpublished study received Nov 19, 1974
under 1471—96; prepared by Uniroyal Chenical, submitted by
EiäflCO Products Co., Div. of Eli Lilly and Co., Indianapolis,
md .; CDL:101691—D)
00094846 Uniroyal Chenical (1977) Residues in PPM: Soybeans: AlanT’ap - 2,4—DB.
(Unpublished study received Apr 14, 1978 under TN 78/10; sub-
mitted bj state of Tennessee for Uniroyal ( iemical; DL:
24 6799—A)
00106041 Ciba—Geigy Corp. (1982) Metolachlor——PeartutS: Layby Applications;
Split Applications (Including at Cracking Mixtures with Nap—
talarVDinoseb) at Cracking Applications with Dinoseb. (CGTp1—
lation; unpublished study received Jul 7, 1982 under 100—597;
CDL: 070977—A)
00106267 Lane, J.; Qjllstran, D.; Newell, J. (1953?) Adaptation of Residue
Methods To Include New Vegetables or To Extend the Sensitivity
Range; Extension of the Residue Methods for Maleic Hydrazide
and Alanap. (Unpublished study received May 10, 1957 under
unkn m admin. no.; submitted by Uniroyal Chenical, Bethany,
CT; cDL:121143—A)
00106268 Uniroyal Chenical (1968) Chanistry of Alanap. (Canpilation;
unpublished study received on unkno . n date under 400—49; CDL:
121144—A)
00106269 Uniroyal Chenical (1967) Residues of Alanap in Soybeans and Other
Crcps. (Cortpilation; unpublished study received on unkncMn
date under 400—49; CDL:121144-B)
-49-
-------
001062’4 Uniroyal Chertical (1971) Residues of Naptalai in Peanuts and
Other Crops. (C ipi1ation; unpublished study received Aug 16,
1971 under 400—75; CDL:003252—B)
00106284 Uniroyal Q emical (1969) Results of Tests on the Mcunt of A]anap
Residue R aining, Including a Description of the Analytical
J thod. (Carpilation; unpublished study received May 16, 1970
under 0F0904; CDL:091558-Q)
00106290 Uniroyal thecnical (1979) Stinmary of t ’anap Residue Data. (Cczipi—
lation; unpublished study received Jun 19, 1979; Aug 3, 1979
under 400—75; CDL:238629—A; 238903)
00106293 Uniroyal Chenical (1971) Alanap and Other Insecticide Residues in
Cranberries and Soybeans. (Cc ipi1ation; unpublished study
received on unkno in date under 400—85; CDL:023355—A)
00106296 Nauatuck O ernical (19??) Alanap: Residues in *iole Soybeans
(Beans and Pods). (Unpublished study received Fe 1, 1960
under 400—49; submitted by Uniroyal Chemical, Betharr ’, CT; C DL:
121133—A)
00106299 Lane, 3.; Gullstrnn, D.; Newell, 3. (1958) Extension of the methods
for ... rr 1eic h. ’drazide and ... Alanap. Journal bf gricul—
tural and Food Ch nistry 6(9):671—674. (Also In unpublished
submission received Feb 1, 1960 under 400—41; submitted by Uni-
royal Chenical, Bethany, CT; CDL:121l36—A)
00106315 Uniroyal Chemical (1976) Residue Chemistry: Dyanap. (Caipi].a—
tion; unpublished study received Apr 23, 1976 under 400—75; CDL:
224234—A)
00106316 Uniroyal Chenical (1976) Product Chenistry: Dyanap. (Ccrpila—
tion; unpublished study received Apr 23, 1976 under 400—75; CDL:
224276—A)
00106319 Uniroyal Chenical (1979) Alanap—L: Label Airendnent for Tank Mix
with aityrac 200 or Butoxone Overtop of Soybeans. (Conpilation;
unpublished study received Mar 8, 1979 under 400—49; CDL:
23777 2—A)
00106320 Knickerbocker, M.; Re, T. (1978) Teratologic Evaluation of Alanap
S Tedinical in Sprague—Dawley Rats: Laboratory No. 5888a. (Un-
published study received Mar 8, 1979 under 400—49; prepared by
Food and Drug Research Laboratories, Inc., submitted by Uniroyal
Chanical, Bethany, CT; CDL:237779—A)
-50-
-------
00106393 Uniroyal Chemical (1972) Soybean Residue Cata Including Dyanap
Applied as Directed Spray, Postemergence. (Compilation; unpub-
fished study received May 18, 1973 under 1400—75; CDL:0087214—A)
00108307 CIba—Geigy Corp. (1977) Residues of Prof luralin, Naptalam arid DI—
noseb in Soybeans Resulting from Sequential Applications of Pro-
fluralln arid Dyanap. (Compilation; unpublished study received
Sep 13, 1977 under 100—523; CDL:231586—A)
00108308 Uniroyal ChemIcal (1971) Residue Sunirary: Alanap and Prefar.
(C ipi1atIon; unpublished study received Dec 16, 1971 under
1400—149; CDL: 003235—B)
00108853 Pink, R. (19714) Final Report: ‘Eight-day Dietary LC50—Mallard
Ducks: chnIcal Alanap: Project o. 117-105. (Unpublished
8t1xiy received Aug 20, 19714 under 1400-36; prepared by Truslow
Farms, Inc., submitted by Uniroyal Chemical, Bethany, CT; CDL:
131 1 198—A)
00108871 Uniroyal C1 nical (1978) Residue analyses for Alanap in Soybeans.
(Cai ilation; unpublished study received Oct 30, 1978 under 1400—
149; CDL: 236527—A)
GS-0183—O1 Pesticide Petition 0F09014 (Acc. No. 1163614) SectIon D: “Determination
of Alanap Residues in Crops” by J.R. Lane.
G3-0183—02 Pesticide Petition 0F2321 (5cc. No. 238629) SectIon D: “Alariap
General Residue MetI d” by J.R. Land
GS-0183-03 FDA Pesticide Analytical Manual, Volume II, July 1967
03—0183—O il Pesticide Petition 0P090 1 1 (Acc. No. 1163614) SectIon D: “The
Determination of Phtha.lic Acid Residues in Cranberries: by J.R. Lane
03—0183—05 Pesticide Petition 0F09014 (Acc. No. 1163614) SectIon D: “Determination
of Phthalic Acid Residues In Watery Crops arid/or Purified
Vegetable Oils” by J.R. Lane
03—0183—06 AnalytIcal CI nistry 25, (1397—1399) 1953: “Mlcrodetermnination of
N—1—Naphthyl phthaT mfc Acid Residues in Plant flasues.” by
A. ’E. Smith and G.M. Stone.
03—0183—07 JAQAC, 148, (776—778) 1965: “N—1—naphthylphthalaznlc Acid Residues in
Food Crops” by R.H. Johnson
03—0183—08 ‘EPA Index to Pesticide Chemicals
-51-
-------
GS—0183—09 Agricultural Statistics, 1981: USDP , GPO, Washington, DC
GS—0183—10 Pesticide Petition No. 0F0904 (Acc. No. 116362) “Residues — SuT mary
Sheet” for 1969, on cranberries
GS—0183 —l1 pesticide Petition No. 0F0904 (Acc. No. 116361) “ResponSe to Letter
June 4, 1970.”
Gs—0183—12 Pesticide Petition No 0F2321 (Acc. No. 003252); ibid (400—75),
June 19, 1979; ibid , (Acc. No. 008725) Piidend n to Report No. 105.
GS—0]83—13 Pesticide Petition No. 0F2321 (Acc. No. 008725); ibid Acc. No. 238629,
June 19, 1979.
GS—0183—14 Agricultural Statistics, 1982: USt , GPO, Washington, DC
GS—0183—15 A Lifetime Feeding Oncongenic Study in Mice. IRDC *399—002B. 7/23/82.
Gs—0183—16 Fink, R., and Beavers, J. (1977) Acute Oral LD 5 O — Mallard Duck —
Alanap technical. Final Report. Project No. 117—123. (Unpublished
study received Nov. 30, 1977 under 400—49; prepared by Wildlife
International Co., Ltd., submitted by Uniroyal thei ica1 Co.,
Retharr ’, Cr)
—52—
-------
p PpPNflTX 11-3
I PRODUCTS SUBJECT TO THE
I REGISTRATION STANDARDS PRO(RAM
I
I
I
ACTION(S) RE0 1JRED TO I
MAINTAIN PE( ISTRArThION
I
I
II. Products That Do Not Qualify
I
I
I For The Formulator’s Exemption
I
I
I
I
I
I A. Single Active Ingredient
I
These products must he rereais- I
I Products*
I
I
I
I
I
I
I
I
I
tered. T obtain reregistration, I
labelinq, packaaina and data I
requirements must be satisfied I
in accordance with the Regis- I
tration Standards (uidance
I
I
Document.
I
I
I B. Multiple Active Ingredient
I
These oroducts will not be
I Products
I
rereoistered at this time.
I
I
However, generic data r ’auired
I
I
to continue the registration of
I
I
the active ingredient under
I
I
review, as described in the
I
I
Registration Standards (uidancP
I
I
Document, will he required and
I
I
some labelina precautions may
I
also he required.
III. Products That Do Qualify For
I
Only when additional restric—
The Formulator’s Exemption
I
tiorts or labeling are needed to
t
I
I
I
I
I
I
I
I
protect man or the environment
will these products be subiect
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
I
I
of ways, including but not
I
I
limited to the Label Improvement
I
I
I
Proaram and special intent
to cancel notices.
I
—
1* End use products of reaistrants who also produce a manutacturina
use product will not be required to he rereqistered provided that
registrant fulfills the requirements specified in the Guidance
IDocument for manufacturinq use product(s). Such end use oroducts
Iwill be sub-iect to the labeling chanoes required for oroducts in “TT”
Tabove. If there are no manufacturing use products registered by any
company end use products will he required to be rereaistered.
NOTE: If all registrants in “I” ahove fail to meet the recuirements m l
I—A and B above, then the reaistrants in “II” lose their riqht to
qualify for the formulator’s exemotion and become subiect to the
Irequirements in I—A and B.
—53—
-------
(14R Apprewal Pb. )UOO-O4 .H
Patje I ot 2 pars
ATIACnP Nr C IWM CAL! ,- IN ‘ %ARY wrr
EPA gistrat ion Pb.: ______________________
Product P4anet________________
! gistrant’s Plane:
I te of CMta Call-In Pbtice: ___________________ for prrxlurte c ntainirij __________________
Pbte: FOr each registered ptodixt, a separate ‘I ta Call—In S i, ’Tiviry ‘ eet” nust he fiLLed in and Sent to the k ency. It yrii
T1 ty tot a jener lc data ext iVt i on or have decided to a, Itintar iLy canc’e i/suspend yrsir reg istrat ion • check the app r i -
ate box for Pbs. 1 or 2.
1. I request a voluntary canceLlation of thin prnduct n r sj:strat ion.
2. I request an end—use exer ptirwi. Attached Is a current, accurate Cnnt :rlent,aI Statseent of my prrsliict ’s ei jnmt-
tion ind1catLrv my qrurce nit active ir1 rediint or a certitlcat ion on the “c, nertc I ta Exent,t ion Statee nt.”
it i select only C t irs-i I or 2 above, sign here • and return this p e to ti’J%.
1) ited ____________________________ ________________
T ieptone Pb. + area code N e Typed or Print ed Mdresg f ill! ferc’nt frm neil I r j ark res
If yrsi ‘ J’.nQn or ny re of the foiLovieg cpt Ions (t s. 3-li), you may chonce thtterent nptLons for different data
requtrenents, but for each data requirmient, at least me box nust he rheckcwl.
tions Pbs • 3-5 for sat isfyl rxj t t ice’s data
i1 r nents
thronic Fesdi
iecie iT4 iiec
_iITE iç y I
1 ratxxjenicity
iesT ieceJ4
r ecies a 4
eciecI 4 c1eaa2 - - ——
3. I an qi nitt(nij exlettrq data for each
data requirmnent box which has been
checked • A c r sheet (Attactinent F)
is attached which sueriarizeg each study
sutinitted.
4. 1 will generate and si.dsnl t data for each
data requirmnent box which has been
checked and sttsni t pnxJrens reports
accx,rdi rx to the schedule in Section II. R.
of this Pbt ice. These data wilt he gener-
ated acwrdir to the Pesticide Peqintra—
t ion: Prqxised t ta Requt reients regula-
tion ttw_0P0i protncois _ , or differ-
ent protooni _ . A cam 1eted coversheet
(Attachnent E) is attached.
5. 1 have entered Into an a- reenent under
FIFRA 3(c)(2)(8)(ii) with one or rmv,re
other Registrants to share the tin-den
of generatirq aid utinItt1ri data and
prrxjress reports for each data requ i rmnent
box which has been checked accord: rr to
the schedule in Section II. of thic Pbt ice
A ccvy of the a re sscnt jq ati act,.’rt and
the rwne an-I pidrlrr.qq -f req i qi r int to
q iLriIt each tPst I -
as an active trijredtent.
u - i
Siqnat ire of limitbori ‘d jiaiT
-------
Arrd uu1 11’ c (ccntd.)
Other Options 6 thrw h 9
.
thr x ic Feeding
C x enicity
Teratoqencity
.Species II
j ies 12
Species Ti
ecies f2
5_pecies Ii
Species 12
6. I claim that I am not obLiqed to arrange to
s i it the data reqtiired by this Notice for
the follo,ing checked data requirect nt
box(es) because the use(s) of my regist:ered
pesticide product are such that, under the
Pesticide Registration! Pt-qxsed 1 ita Re—
quirenents regulation, the.ce data require—
ments do not a ty to my product. Attached
is an explanation of why my registered pes-
t icide product is not subject to the
Requireisents t ether with a current and
accurate Confidential Sta .’nent of my
product’s ccz it ion and current Label
for_my_registered_pesticide_product.
I
I
I
7 • I enclose a c JTpleted application to viend
my registration by deletinq one or nore of
its currently registered u s. C ce this
anen nt is approved, I believe the data
requirements in the checked boic(es) will
not_aWly_to_my_product.
I
8 • I request a waiver fron t r w ’ obligation to
arrange to subeit data (or the fol Loving
checked data requlr4ment Fox(es), because
the active ingredient in my registered,
pesticide product is a lo..’ vo luiie/mt nor
chemical. Attached are the ducui nts
necessary (or a l v voltjm’/minor chemical
request_acoording_to_Section_III.
9. I have sulriitted an offer ac specified in
Sect ion III of the Not ice hut have been un-
successful in entering into any aqreeeent
to share the birdens of qenerating data
with other registrant(s) who is ,ivnitted
to generate the data. Attached are a ies
of the of fers I have made regarding the
requ I resents indicated by the checked data
box(es). PJso attached ic proof of
receipt of the offer(s).
Tyrw.d ot Printed
Nidres (If cIiIfc’rr’nt (ton acklrpqs)
(7 1
(71
Dated Signature of Authorized Rept-esentive
Telephone Jo. + a r”a c 1’
-------
Appendix I L l—i
PRODUCT SPECIRIC DATA REPORT
‘EPA R istration No. Guidance t cument for________
t te
R istrat1on
Guideline No.
Name of Test
Test noti
required 1 am canplying with
for my data requirements by
product Snhnit—
li8ted ting
above t ta
(check (At-
below) Citing MRID# tached)
(For ‘EPA Use Only)
Accession ?‘& nbers
Assigned
155.2O
PRODUCT
CHEMIS1 Y
61-1
identity of
ingredients
61-2
Statement of
c oa Itlon
61—3
Discussion of
formation of
ingredients
62—1
62—2
Preliminary
analysis
CertifIcation of
.
llmlt8
62—3
AnalytIcal methods
for enforcement
limits
,
63—2
Color
63—3
Phyalca]. state
63— 4
( or
63—5
Melting point
63—6
Boiling point
63—7
Den8lty, bulk-
density, or
specific gravity
63—8
SolubilIty
63—9
Vapor pressure
63—10
Dls8oc lation
constant
63—11
Octano]Jwater
ç*rt ltlon
coefficient
63—12
pH
—56—
-------
Appendix lI1—l (continued)
—
R iatration
Guideline No.
xne of Test
Test not
required
for my
product
listed
above
(check
below)
.1 am complying with
data requirements by
(For ‘ A Use Only)
Accession Ni.m ers
Assigned
Citing MPID#
Sulinit-
ting
t ta
(At—
tached)
63—13
StabilIty
63-l i
Oxidizing/reducing
reaction
63—15
P1Rnr .bIlity
63—16
cp1odability
63—17
Storage stability
63—15
Viscosity
6?—19
Miscibility
63-20
CorrosIon
characteristics
63—21
DielectrIc break-
down voltage
158.135
IOXICCLOGY
51—1
Acute oral ID-SO,
rat
.
51—2
Acute dermal
r.D—so
51—3
Acute inhalation,
LC—50_rat
51— 4
Primary eye
Irritation, rabbit
81—5
PrImary der’mal
irritation
1—6
Derma]. sensitiza-
tion
—57—
-------
APPENDIX IV- ]
o& abtaind the data. from another
flz (IdIPWT) applf flt copied data
(rem a pu 1f 4t OO applicant obtained
$ copy of the data from WA).
Cd) The appilcant sheil submit with
bi’ app11e$ & that A.
Ita i,a&ua’ m of the properties, oft-
and misty of the formulated
esd as product, may not i o ’ 1 4 ’ any
data. es espporg the apll’I.
I the foilow data
(1) ‘h ta th applI t hes sub-
mitted to A” para aph (b) of
irti
(23 Other data pertainthg to the
of the product’s active Ingredi.
ante. rather than to the misty of the
an em — and
(3) Ltl g tolerances, food additive
r uls’ ”c and other
ciursoces Issued tim4p
Ybod. re and Cosmetic Mt
It the applicant owe that any
Item of data be submitted this
_____ 7 51 ganerated bY (or at the ex.
panis at) soother p who orlgnai-
17 , .th , , ,I ad the data to A Car 1
prsda. ’u.iwwr . &) on ar after Jaou-
say i. ira, to support an appfl
i ’ -dW’- up.rtawthl 3 5
0 ? sm.Ili4l tt 4Anf f & now
me to an - 4-th g re om*tian. or for
rers tiaticu C”” the applicant
and the orl na1 data I” mitter have
r M .d wrtttan aceemaut an the
nunt and the term of paymant of
any ecm _ p’wi _ .atlon that may be pay-
Th ? R ss cn
3tCX1XDXII) with reiard to s t
of the sppll n,, the applicant shall
to A a t ! .,it that he
ham furnished to anch su Identified
data vshmjtt.r
Cl) £ a of the applicant’s
I tang tO apply for reglatiatfoo , Includ.
tn* the proposed product a e
(2) An offer to pay the person cam.
I—P 4 nfl , wtth re zd to the ap ,aL
of l bs wplicaxio , to the . ‘ ‘c re-
ulredbA sections 3 cX1X
(3) An M rIflae.rfrq , of the ltems
Ofdat$tOW jC th*offe appu
(4) An offer to negotia-
tions to uca t the s i and
to of comp ati to be pald and
5) The appflca Vs addrem.
sad telephans n ber.
§ 162.10
(Z) It the appUcazrs product con-
taLus any active In edlent other than
those that are present solely because
of the Incorporation Into the product,
dL r1 g formulation, of one or more
other registered pestidde produc
purehued from soother producer,
then the applicant shall also c rnpl7
with *162 . 9-5 ii to such active tn e-
dient . sod th appI( nn shall con-
tain an ac ow1edgm t that for por-
poses of P ’RA section 3(cX1XD) the-
appI” on relies on (and any remit.
tag reelsuation should be reesrded as
If It were based on the Admth1s ator’s
of) the following daw
, C l) All data submitted or spe ff l1y
cited by the appIf t In support Of
the regiatiatioo and
(2) other Item of data in the
4gim y’ m. whichi
(1) Coi1J ar a the properties or effects
of any such a ve In edIanti and
(U) Li one of the types of data that
L would requfr to be submitted for
ti.ntffi review by A If the uppil.
cant sought the II .J re s ation
P ’R.4 . $e on 3(cX3) of a
- product wtt tf on and I tae d .
ed ‘a t”-’ - ’ to those proposed for
• the ppIf proAur ‘ the
dea requfremauts In effect an the
date A a awvves the applicant’s
pr t appU lion.
(3am. 3.6, and of ? ftA. U “ & 7
.3.C l3Idseg.)
(44 PR 5IL Maj ii. L 51 51
I IU.1I IabelMg ruqiaframensa.
(a) Oan.ral—( 1) Confmats of the
( abel Ivery pantidd products shall
bear & label cont ”fr’g the lntor .
• tian specified by the Mt sod the regu-
t.CIOns In this Part. The contents of $
label m show clearly and p -om1 -
_____ the ZoUawtn
(I) The arnm brand. or tisdemark
tmñ, , wbmh the product Is sold as pro-
smibed In pazwaph (b) of this
CU) The sod addranm of the
producer, regis a.nt, or person for
whom produced as presoribed In pan ,-
graph (c of this ssction -
(ilL) The net contents as pranalbed
In pari apb (d) of this section
27
$. 1 ,vlroasmsntal Prot.cllon Agency
—5R—
-------
4162.10
hue 40—P,osecilon of Iwwlronment
(l v) The product rea.tlon
number as pr thed In parwaph Ce)
at this aection
Cv) The producing 11 Piiv .i t
as pr athed in paragraph (fl
of this s tion
(v i) An Ingredient , tatement as pie-
a 1bsd in paragraph Cg) of this
Cvii) Waz g or precauticnaz7 state-
as prea lbid In paragraph (hI
at this tIoa
(vUl) The directions for use as pro-
soribed In paragraph (1) at this s.cticn
and
(lx) The use ‘f tion(s ) as pro-
.sorlbed In paragraph Cl) of this section.
(3) ? uesfn.nc. and t. lbtiUp. CI) All
w ements . graphic representa-
Mains. d 1g I or other tnfor ,±1on re-
quired an the labeling by the Act or
the regulations In this part must be
clearly legible to a person with noim l
, 4 w n , and must be placed with such
iuIP1CW C (U compared with
other VoidS. stat mfnta , or
grip ie mEt ’ on the labeling) and
r ed In such termz as to ron it
tlkhjy to be read and t2nñ ,?,tQ0d by
the or nary i ndividual md,r tom.
ary conditions of purchase and us.
(U) AU ro lrI!d label text mu
(A) 3. set in 6-point orlargertype:
3 Appear on a clear con astlng
ba grouc and -
(C) Not be obscured or crowded.
(3) Langvap. to be used. Afl required
label or labeling text shall appear in
the I 1 H h language. owever, the
Agency may require or the sppUcam
mar propose additional text In other
languages as Is considered nec ary to
protect the pubUc . When additional
In another language Is necessary,
all labeling requirements will be ap-
plied equally to both the ‘ gH’l and
other-language versions of the label.
(4) Rdcem.nf of Label—(i) GeneraL
The labs! shall appear on or be secure-
ly at” ” ed to the Imrsedla.za contain-
er of the p. th Ide product. For pur-
D ii of this Sec an . and the mis-
binding provisions of the Act, ‘ se-
curely attached” shall mean that a
label can reasonably be expected to
rai,r ’ M affixed during the foreseeable
conditions and period of use. If the tm-
mediate container Is enclosed within a
28
wrapper or outside container through
which the Label cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tain r , LI It Is a part at the p ge as
fV ”.’f]y distributed or sold.
(II) Tank care and other bulk can.
taingr,—(4.) Transportation. While a
peçfi.4aIg product Is In uanalt. the ap-
propriate provisions of 4 CPP. Parts’
110- 139. concernIng the transportation
of hseardous materials, and spaciflcal-
ly thu , provisions concerning the I i .
buffing , marking and plecarding 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 portabl. bulk contain-
er, a copy of the aceepted Label must
be attached to the shipping papers,
and left with the cansl ee at the time
01 deUver ’
(B) Storaia When p. tlctd , prod.
ucti are stored in bulk containers,
whether mobile or th nary . which
In the custody of the jser, a
copy of the label of lab.1f”g IngjtIaI11 g
all appropriate ections for use, shall
be securely t’ed to the can fT r-
In the Imnt dlste v1 lty of the d li .
charge control vaive
(5) laZe. or m sLeadfnq staEa,non .
Pur ant to section 2lqxlXA) of the
Act, a pesticide or a device declared
subject to the Act pursuant to
I 162.15. I a misbranded If Its labeling Is
false or m1a1” 4 ’g In any particular
Including bath pesticidal and non-pea-
1 4d.i of
or representations In the labeling
which onstItute misbranding Includs:
(I) A fals, or mlsI’ 41 g s en1ent
concerning the composition of the
product
(U) A false or mlal.tñing r.ment
concernlnf the effectiveness of the
product as a pestiefñe or device:
(LU) A false or m’”’y statement
about the vaLue of the product for
pt rpo.u other than as a pesticide or
(Iv) A false or mIalea’ 41 ng comparison
with other pesticides or devices:
Cv) Any statement directly or Indi-
rectly Implying that the pesticide or
device is recommended or endorsed by
— —
-------
Agency
g 162.20
£07 1(SflC7 of the Federal Oovern-
man
(Vt) The of a pesticide which
concalne two or more principal active
ln idtents If the . sugg t.i one
or more but not aU such pr dpel
a v incedlants even though the
of the other lneredlent.a are
afarid elsewhere In the lab 4”r
(iW A ue need In su a
way as to VT. a false or ‘esdlng Im.
pr On to the purthaser
( th3 tmbel d1sM l, .,3 which ‘ ga& .
or de wct om labeling stat-a”.’ re-
quired ‘ ‘ the ct and these regula.
(l x ) ‘ ‘ *5 to the fe of the
puetidde or l edlenra, In hi1tng
such as 3a1g,’ nonpofson .
O i, •n nj—1c—s,• irmlese’ or-
AVf 1 to h -” and pun” with
or without such a qualifying phrase as
wben need as dfrected” and
Cx ) Nen .aizmarfcal and/or compara.
the ‘ “‘enta on the atcty of the
produot, including but not Ibelted t
( A) C ” ji all na aJ Inerudi.
(3)_ Among the Iseet to c h.mj .
eats owo ’
( 2 “Pollution appruv 4 ’
(6) nai rtnted Zabeitn (I) ev t
U provided In P$rW i ph (OXOXU) of
thts ction . anal pr i nted labeling
m be submitted and a pt prior
10 r gtgz ±ion Eow, aL printed
labeling need not be lubnhttt.d imdfl
att label te have been pravtda .
sUp *ccspted by the Agency.
(11) Curly leelbie reproducUc or
photo zednctlone wW be s pt for
uII 1kb li such as th 02 • silk-
1 .Psu14 directly onto Vase or metal
or large bag or um labels.
Such r oducti must be of mlcto-
mm reproduc quality.
(b) Name, binnd, or bimg, 1)
Tb. e, . brand, or v4ema onda r
which the puetiold. product ta sold
on the front pazt,j of the
(2) No name brand, or 14moar
7 appear on the label whiclu
Cli) ass not been sppr P y the
through registration or
P1 tij egiitr o as an addi.
.me puzmaa to 4
29
Cc) Name and address of producer,
registrant, or person for whom pro-
duced. An qnallfled name and ad.
g1v on the label shall be can-
sidered U the n i e and addr of the,
producer. U the registrants ‘ e ap-
pears on the label and the egistrant Is
not the producer, or If the “ e of the
person (or whom the pesrf ’44 , was
produced aopezr an the label. It must
be quaZ1 e4 b7 appropriate wording
such as Piekad for • ‘I’ ‘Dis 1bu&.
to show
that the . Is not that of the pro-
ducer.
(4) Net wetgM or measure of con.
ti Ifr. (1) The net weight or misure
of canten shall be uxctustre of wrap-
pers or other materia and shall be
the average ntent ‘ l. ” expllnftly
. tMa1 as a It 4,ifi,iiim quantity.
(2) If the pesticide I a Uquld, the
net content r 1nent shall be In
terms of liquid maswe at W P (20C)
and shall be aKP .ed In canveng n
American of fluid aes. pifite .
quar and iafl
-(3) Itth, pi’ rid . is solid or s f ”o-
lid, viscous or pr ited, or Is a mix.
w at liquid and solid, the net con.
t n i t shall be In t
a .---q4 as avclrala
peimde and o
- (4) .a cans , set I tent shall be
sri±ed In terms of the largess p” J’ie
uSite, I.e., “1 pound 10 ounces” r h,r
than 20 otm e&”
(5) In adnft qn to the reqWi
wed ad, net content may be ux-
pr ed In metric ‘
(6) Vsdutl n abovi ! v -f ifr’ um .
tent or around an average is permiset.
ble only to the extent that It rsp
note deviation suavoldable In good
manufacturIng practice. V’&rlatio
below a dated nilnft’ium Is sot permit-
ted. In no case shall the average con-
tent of the In a shJpii iit
below the dated average consent.
(0) ??oducf rvgisb’of ion
The registration v m, er ‘ v’ d to
the p 4de product as the e of
registration shall appear on the label .
preceded by the phrase A Ragta.
tration No..” or th. phrase i & Rag.
No.” The registration number shall be
set In type of a site and sty le v”fl ’
other r1nt on that part of the Label
on which It appears and shall rtm par
—6 ( 1 —
-------
4162.10
Thf• 40—Pietee lon o# Ezivirianm.t,t
silel to it. The registration number
end the required Identifying pb..ra.,e
shall not appear In such a “ - er as
to suggeet or Imply recommendation
or endorsement of the product by the
A .
(2) ProducIng ertabL&&meafs reg is .
fre on um en The produdni eata
1!.Itma ,lt regi ation number pre ed-
.4 by the pbue 1P& Ln. ’. of the
L ‘ ent at which the prod-
u was produced may appear In any
p1ftkhle location on the Label or
diets It must appear on the
wrapper or outside container of the
package Li the A tshIbiPlPnent reg-
Ia ation number on the Imedlat.
. .. t&f?tsr nnot be dearly read
through such wrapper or contain.’.
(gI !ngrsdisnf sfa*eman.C—(1) Gensi’
W. The label of each pesticIde product
must bear a stst””t which cout.slns
the . end percentage by weight of
each active Ingredient, the total per-
tag , by weigh: of all Inert Ingredi .
en and If the pesticIde nr21n a .
lc in any for. a atat”.”t of the
percentages of total end waZsr4oIuble
‘ lo calculated as elemental. ax-
senf The active ingredien mu be
v’ ted by the t “acttvw Ingredi-
and the Inert Ingredienta by the
term Inert in ants,” or the chin-
1, i of terms when’ appro-
prIats. Bath terms shall be In the
am . type size, be shined to the ame
msr and be equally prominent. The
5 2tI ,nt ert Ingredlenre, none” La
not required for pearfr4 t which con-
Coin 100 P1L *L t active Ingredients.
nI the Ingredient statement Is a
complete analysis of the pesticide, the
term “analysis ” shall not be used as a
“ dlng for the Ingredient staZ ni . ’it .
(2) PositIon of ffig,vdirit statriwnL
C I ) The ingredient statement Is nor-
.fly required on the front panel of
the label . U there Is an outside eon-
t M.p y wr ppsr through which the
Ingredient ta em nt cannot be ctes ’1y
read, the Ingredient statem.nt must
also appear on such outside container
or wrapper. U the sine or form of the
‘ ege “ ‘ It ImpractIcable to
place the Ingredient statement on the
front panel of the label. permimion
may be granted for the ingredient
s ”•”t to appear eLiewbere.
30
(U) 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) Namer Co be ased In Ingredient
statement. The name used for each in.
gredlent shall be the accepted
common name, If there Is one, fol-
lowed by the cb .” .1 “ . The
common name may be used alone only
If It La wail known. L I no cor i ni ___
has been established, the cheml ’
r .i e alone shall be used. In no
wlfl the use of a ademark or propri-
etary name be permitted uni.is such
n * baa been accepted as a common
name by the Administiator tt .,lø , e
authority of Section 2 (cX6).
(4) Statements of percentages. The
percentages of Ingredients shall be
stated In terms of weIght-to-weight.
The of percentages of the active
and the Inert Ingredients shall be 100.
Percentages shall not be expressed by
a rang, of values such as -25%. If
the uses of the pesticide pro4uct axe
expre ed as weight of active Ingredi-
ent peronlt area, a sts*emeni of the
weight of active ingredient per onit
____ of the p s fr4 4 5 fornnilatl ”n
shall a.l a appear- In the Ingredient
(6) Accurucy at stated percentages.
The percentages given shall be as pre
cue as po bIe reflecting good menu-
fac ring practice. If there may be on-
avoidable variation between manufac.
tining bt4ea, the value . it ±ed for
each active Ingredient shall be the
lowest percentage which may be
present.
(6) DeterIoration. Pesticides which
In ch.” c4J composition sig-
N4 !1tly must meet the following la-
beling requfremantg
(I) In coses where It Is determined
that a. pesticide formulation changes
cb. 1 ,l composition slinlflcently.
the product must bear the following
statement In a prominent position on
the label: “Nat for sale or use after
tdatel.
(II) The product must meet aLl label
I*ima up to the expiration time Indi-
cated on the labeL
(1) Inert Ingredients. The A Jnl-
tiator may require the name of any
-451-
-------
3 _ pt . ’ I.
ii P eted4 .n A eacy
162.10
____.
,
I
.
I —
ax
ax #
L_ l.C.
LIt bx q .2
.2 lx 2 n* ....
a. ee a eqi .
I
lx a *lx.
‘a—
U’ I..1LI. ee
ee ix ax
P a.xs ix
ix II.
,-__Il_
7
ts_u 7
. .axi.
7
-
1 ....L., 7 x .
g
7*.—
(I) Reman hazard elgna ord—(A) T rf fty Categox Is cot peaittat
citp Cat.vorg L All p 1de prod . wh the Agency det mlnza
meeting the oriterla of To ó ’ that such labeling Is nec ry to pre-
4 -r7 I shall bear cn lie fton , .ns 1e *4 v3 effec on
anet the rt ’ word Dangar.’ In ado- man or the onvironmant. In no mee
tt ii if the product wee 2 4gfled te-. . i, ji - ____ ___
Ta ty Conga, ? I on the basIs of Ifa .. qf wa, on the boot
, f Jo4ai or dermai to ty (as of a labeL
lls from skin and eye locaL ef- Dory pea.
tecw the word “Poizcn’ shall wear , j .e on the
red on a beekgrmmd of distinctly fr n p.n,i t a sr t ent keep ant of
on a ing color and the skull and rea h of oni, In cisea
II bI. flet shall appear In I mediate where the likelihood at eu” ° t with
‘oc lmIty to the word polson.” _____
(B) 2’balcttv Categorp IL All peat!. Ch1ld diarifli dIst fbntlcc. market-
ds produc meeting the criteria of in$ garage or us. Ii dimc *ted by
Cat.gcry on the the Ip11 t to be ex eme1y remot&
___ ___ or If the nature of the pestlelde Is such
sons c.i the r ’ ward Wsrn . ___ It- :
(C 7 cUp Catauorv !ZZ All peat!. °“ th1l & tile
da products meeting the criteria of y wi ve this requirement.
L’oxicfty ZIgory shall bear on (fJj ) tgiiign 41’ pro Isel
Ib m froni panel ‘ - ___ . .Ca . mgnt—(&) T cUp CaUgor L A
sut” .”t of practical ea ”t ( rzt
( ) 2’ ei Cateqor )y aid or other) shall appear on the front
eld Products meeting the te of panel of the label of all peat1c*d fall-
To fcity C&tegcry IV shall bear on the Lug Into TOXICItY Category I an the
front 4fl 5j 5 I word CaUt1OIL’ basis of oral, nt I tf on or dermal toz.
(B) Use of aWnal toorda. ee of any leity. The Agency may, however.
gnal wardte ‘ oe1ited with & higher permit reisonahie v szioa In the
31
Lean Ingredient(s) to be listed In the
Ingredient statement if he determines
that such ingredient(s) mu pose a
b rd to men or the environment.
(hi Warni nv3 and precautionary
datama & Required waruln and
precautionarY sta ement3 concerning
the general areas of toxIcological
rd eti’ ’v kI 2d to children.
environmental hazard. and physical or
heml 1 ) io rd fall into two oupe
thom required the fr penal of
the labeling and tho which may
appear eLsewhere. Spetiflc require-
mente concerning content. placement.
type size, and prominence are given
below.
(1) Required front panel .UatamznLl.
With the exception of the child
) ‘°‘ ‘d warning i ”’ t . the text re-
quired on the front panel of the label
Is determined by the ToXI ty Catego-
zy of the pesttct The category Is as.
9!nd on the basis of the highest
) ‘ d shown briny of the th’ ’u
in the table b.lov
— 2—
-------
9 l62. O
places tmnt of the statement of pr cti.
oil t ant Is somo reference such
as “See atalement of practi.caL treat
ment on back panel” appear an the
front pitl’litI near the word Poison”
and the skull and croasbones.
(B) Oth.r toricap ories. The
of pnctlcal 3
requli d on the front panel except as
due 1bs4 In pirwiph (hXlXllIXA) of
th a The appilcint may, how.
sv . Inelude such a front panel stat..
“ t as hi. option. 3t t i t.rts of
pra loiL e. ent are, however. re
qufr d elsewhere on the label In
accord with pa apIt ChX2) of this
section If they do not appear on he
fri 151 t pan I
C iv) I!acemzat and prumfn.nc& All
the requ e front panel wa ng state-
“ shall be trouped together an
the label , and shall appear with suffl-
d $ Di m t41e relative to other
tranS panel text and iphlc aterla1
to t.fr* thait, tistIf it y to be over•
loaksd n eussomary conditions of
p aae and e. The following table
shows the ,itMl,rnan type s z reqthre .
— for the front paneL warniog
on various s es at Iabel
C l i) I wttZaL hazards. Where a.
) ‘ d sxtsu to non target Ø 1 i t
aduding h”- and domestic ani-
, ,,.lit preea.ii nary statemenr.s are re-
Quired st2thlg the nature of the
I . ._ iu it
i l
i t
R ws0
—
s
-w.
,. l
.__
i t $ 1ñ
1o tI
I
ae tIex
to
Is
I
14
‘I
•
S
I
10
tl
(2) Other reqeind toarn n and pre-
— s emen The warnings
and JM uUonax7 stata r.ts as re
quired below shall appear together on
the label t1Ttd the general he -dlng
“Precautionary Statem. ts ’ and
tiiir4itt appropriate subhs AIr of
____ to 2 m , ,ta and Domestic Aol-
“Thvtronmental R’ 4” and
“Physical or Chit t s.( 3a .rd. ”
(I) Hazard Co humans a sd domestic
animaLs. (A) Where a esists to
h 1 , vIa or domestic i,,n1it precau-
tionary statement . are required mdi.
catlng the particular ba ard. the
route(s) of Ø3 SOd
dons to be r akit t to avoid snddant.
Injury or ‘ 4 ” ge . The precautionary
p*rwaph shall be Immediately pre-
ce rd by the appropriate - ‘d ‘ 1 r ’ 1
war
(B) The following table depicts typt-
o il eoiazttonary st ,tients. These
must be modified or ox-
to reflect specific ha rda.
— and the appropriate preoiu-
dons to avoid potential adent,
Injury or &lar ,tEge r2 ,tp 1e 5 of the
! ,01 Pd statements and the circum-
32
T i f f . 4O—P .t.dI.n of Environment
,
y
—I —, __
‘ ‘
-
I
P .. —..o E - L_ cv
1. Os Is I01I
J. Os it itt
— — .—.a o _ i---’ ... i_gri
L
‘ —--..—
m tL Oo It 011 i tt
‘ . w I . WISI all AIt
J
n .. !l .sa J
I______
U .a .s
ItS UI. Os s Ius Is its (0* it
— L Os to gis it —. , — or
. tPw — fUS i tU L
Cit . . Ca lI 3& Os t
I I I al dolrq. Nal I t.lo.
U________
—1 bUs5 ov qt
UI. - (0* 101W 0*L
. s dalu %t
it .—- 1_S.
U iti,J. CA .
— Stsa,j.
——
D
tils . _&1
—63—
-------
* 4 , 11 1
Pi’efsdlon Ag.ecy
162.10
IM I 4 P WbIC.b they are required
foL Iow
(A) If a peatidide Intended for out-
e contains in active tnçedlent
wIth a i I1.n i 1te oral LA. of
100 or I . the i’ ement This Pesti.
did. i i Toxic to Wfldllfe’ Is required.
(B) If a pesticide Intended for out.
èoor us, an active Ia edIent
with a flab acute LC oil ppm or
the , 1ement ThIs P stiti Is Toxic
to PIab’ Is required .
(C) If a pes de Intended for out-
door use co’. i ” an active lneredient
with an svtan acute oral LA. of 100
mg/kg or lem. or a subacute dietary
LC 1 . at 500 ppm or less, the sta enc
“Tb Pesticide 13 Toxic to Wfldllfe’ 13
requ
C ) If dither de”t history or field
W’dtn demonz sLe thu u se of the
(I) ftectiani for O’a.—U Gewol
nen a- I) Adequacy and
0! dIrections. Dlrectio s for use
must be stated In terms which can be
easily read sad mderatood by the
avenge pensou likely to use or to su-
pervise the use of the pesticide. When
followed, directions must be adequate
to protect the publIc born fraud and
bv personal Injury and to prevent
I*soflabIe adverse eifecta on the
4 n 1gm,1 I.ftt .
(II) ?toeesw,ig Of dfiwegton., r
Directions may appear on any portj
of the label provided that they are
co *cuous onougn to be easily read
by the user of the pe t1czde podijct
Directions for use may PP on
pesticide may result in fatality to
birds, flab or the statement
‘ Th1s pestIcide is extremely toxic to
wildlife (fishY ’ Is required.
(E Par uses Involving foliar applies.-
tion to agricultural cops , icresta, or
¶ha o bees, or for mosquito - ace-
meat tre ”ts , pesticides toxic to
p flbt rh1g Insecta must bear appropri-
ate label t ’ TrPf ns
CP) Par all outdoor uses other than
aquatic app [ iea ns the label muss
bear the caution aeep out of 1.Jr.
ponds or streams. Do no; cont 2n te
water by ‘I.. ifv g of eqnip ient or die-
posal of wastes,”
(flfl P?tysacgl or cPiemicai hazards.
Warning sta4 mP,1te on the
tty or explosive characteristics of the
pestlM4 , are required as fallowr
prInted or apb1e matter which ac.
companies th . pesticide -ovlded that
(A) If t W(cd by the Agency, such
printed or uapthc matter Is securely
attached to each D1iie of the pesti.
tide, or p’ cmd within the outside
wrapper or bag
C8 The label bears a reference to
the dfrecticns for use to accompanyIng
leaflets or dronlars, such a. ‘See di-
rections in the . IzIosed cfrcularr sad
(C) The A in1stratcr determines
that It La not nec .—.ry for such direc-
tions to appear on th . labeL
(UI) L ption,, to r,q?themanf for
dIrection for tue—cM Detailed direc-
tions for use may be omitted from La-
beling of estiddes which are thtended
I
Iq iem
a a • 4 a
S
er
— —. II a $ c...__
•I. es
— =-=
-
. — , l
— Iii,-—--- ix- P
...
r_ cm — — —
- S fl —
— - ,
— I — d a a
.__ .. . . m.
isrP .
‘ . .—
en
a.
F iern
f_ m $ —
.
Os . a s a
33
-------
§ 162.10
HI. 40—Protection o# Envfronm.nt
fez use only by nu!act ers of prod-
ucts other than pesticide prodUCts In
their regular manufacturing pruc ei .
— that
(2) The label Isarly shows that the
product Ii Intended for use onLy In
man”f’.rti rt g proee es and specifies
the typea of products involved.
(2) Adequate infcration such sa
sheets O bujietins, Is
available to the trade specifying the
type of product involved and Its
proper use In manufacturing proceas-
(3) Th. product wlfl not come into
____ of the general public except
after Incorporation Into fl Med prod-
and
(4) The- Admlnlstsztor determines
that ch directions axe not nece sy
to p u& unreasonable adverse 01-
fe on man or the cn’ifrunm. t.
(B) Detailed directions for use may
be itted from the labeling of pesti.
dde products for which sale Is limited
to physicians. veterinarians, or thug-
£ — that
(1) The label clearly states that- the
product Is for use only by physi
or vs rinart*na -
(2) The A in1s ator determines
that such ecv1ons are not ne ary
tO 1 pM YL &t ascnable adverse 01.
facts on man or the environment and
(3) The product Is also a thug and
regulated “ “er the provisions of the
?ederal Food. Drug and Cosmetic Act.
CC) Detailed dfrecti for use may
be tted from the labeling of pesti-
dde products which are intended for
use only by formula nrs In preparing
pesticides for sale to the public, pro-
that
(2) ‘There Is Infor, , th n readfly
&v.41 bl. to the formulators on the
e ’mpoeit1cc . t”wletty. methods of us ..
appll sNe resthctions or Umit ons
and effecttveneus of the product for
pa ’ct”e p poa
(2) The label dearly states that the
product Is Intended for use only In
manufacturing, (O HIE±1flL
or repafrlng for use as a pesticide and
specifies the type(s) of pesticide prod.
note invoIved
(3) The product as finally manl4ac.
tured. formulated. mixed. or repack .
aged Is re 1ztered and
• (4) The A ’ ”n1 trator determines
that such directions are not necessary
to prevvnt unreasonable adverse 01-
facts on man or the environment. -
(2) Conteniz of Dtrscticn.s for Use.
The directions for use ahail Include
the following, under the he d1iigt • j.
reetimis for Use’
(1) The t” t of use
tion as presoribed In 162.10(1) tmmedl-
italy under the 4aH g Dlrections
for e.
UI) tmzn.dlateIy below the state
men of use ifflt tloc . the state-
nm,it “It Is a violation of Federal law
to use this product In a
sistent with Its labeling.”
(111) The tite(s of applf th rL as for
pIe the ope, “ ‘ areas, or
objects to be treated.
(lv) ‘The target peatts) aesodatad
with each site.
Cv) The dn qe rate aw +e ted with
each site and pe
(Vt) The machod of app” 4 oc. In•
eluding Instructions for dilution, 1
and type(s) of appIi tion g.p-
pera&us or equlpm.”t required.
C VI I ) The frequency and £fi thlg of ap.
pli ”’ 4 ” ' ’u “ e ’y to obtain effective
results wtthout unreasonable
adverse effects on the
vUl) Specific Um1tatlnn on reentrT
to areas where the pesticide has been
applied, meeting the requiromenre
concerning re try provided by 40
Pert 170.
( l x ) Speclfl directions concerning
the storage and disposal of the pesti-
cide and Its container, meeting the re-
qisirements of 40 CFR Part 165. These
Instructions shall be grouped and
appear m ’ the ) .41 g ‘Storage
and DtsposaL This h.adlng must be
set In type of the i e ‘ “I sizes
as required for the child ) ‘-. d warn.
Ing (See Table n i 162.10(h)( lxiv).)
(xl Any IIm1t .ti ns or reatsictions on
use required to prevent unreasonable
idvvz e effects, such aa
(A) Required Intervals between ap-
pll ’on and harvest of food or feed
O L
(B) Rot tfm .i op restrictions.
(C) Warninge as required ag 1’ t use
on certain orops. objects, or
In or adjacent to certain areas.
(Dl (Reserved)
34
-------
P,el.cl ofl Ageecy
§ 142.11
( ) POT rea teted use p tlcfdes. a
1 hI! . L that the pesticide ai be
appUed und ? the direct supervision of
a c*rtlilid appU tOr who La not phys-
L IIY present at the site of appliOn
but ngnetheI svaliahle
p on applying he pesticide.
the M boa determined thee
pesticide may only be applied und
the direct werVislOn of a carti ad ap-
pllr t alP who Is phycice.U7 rdlflt
• (7) Other par int IniormisX1 ”
wbf the 5ZO determines
to be e 7 far the protection of
n and the environment.
(I) 3inLr,t” t of U ’s. flc ti OIL
BY October . L910. all pesticide prod-
occa imt bear on their labels a te-
ment of use as destbed
In parwwhs (l x i) and (2) of this
Any pest1rf prodnnt for
I see uses are 4” f ed for jon.
esat uss and otber for restricted use
shall be uparately labeled actording
to the labeling r ”ds set forth In
this ml eeti n. a nd shall be mutated
se se rata products with different
_____ numbers, one bearing .
only for general use(s) and
the other bearing duections for re-
wlcted use(s) except that, IS a. product
both r lctod us(a) a 4 general
i1 , both of th e uses may appear
on & product labeled for resirlctad use.
ich products shall be subject to the
preettiona of 4 i62.iO(1X2).
(1) General Die 4aa(ficeffon. Pesti-
tide produ b 4 g directions for
(*) general shall be la-
beled with the exact W0r O I1
‘ 1 ’on ” ‘mmedlately below the
h ’ g Dlre ‘ions for use. ” And ref.
erence to the general
that eszg or f pH that the jon-
iral utility of the pes’ 1 de extends
beyond thou purposes and uses can-
tsined In the Directions far se will be
canstdered a false or mis1e 4 ft’g state-
(2) Rerfrtcird Us, slfleetfoii.
P,r’d . products bearing dl ction
for use(s) M ed reamloted shell
beer v ” ’ of restricted use cue.
, iIi on on the front panel as di-
seribed belaw
(I) hont panel stofemenf of r thjCf-
ad use c i sl/tcntion. (A) At the top of
the front pastel of the label , set In type
of the same rrilrthiium sizes as required
for h im ” ) ‘d 4 g” l words (see
table in 4 162.i .OCh)(l)(lv)). and appeor•
Ing with sufflefent prominence reLative
to other text and graphic material on
the front panel to jt unlikely to
be overlooked castomary e”dl-
ti of purchas. and use, the state
m.i t ‘ e5t2ictl4 Use Pest1cid ” shall
appear.
(B) Directly below this sr ”ent on
the front paneL a summary s’at ent
of the terms oL restriction Imposed as
a p econ fth n to registration shall
appear. If use Is restricted to certified
applicators, the following s tem t La
rulred ‘Par recall sele to and ma
only by Certified AppilceIcra or per-
sons ander their direct supervision and
only for th uses covered by the Car.
tt Sd ApplicatoVs certification.” If.
however , other regulatory restrictions
are Imposed, the Alnisirator wfll
‘ .lI”e the appropriate wording for the
terms of restriction by regulation.
(k Adverticing. EBeserved3
(40. PR.2020$. Juir 3. 1iT5 40 PR 323 .
AU& 1. 1975 40 PR 355fl. AUX. 21. 1273. as
w -’ — ’ at 42 PR Sill. leO. a. 1 27$ )
4 1 I1 1 . for determl toes of —
- i’ . ’ adverse
(a O’Uarin /br latsimzca of Notic. of
fluent to Deny 3egistration . Cancel
Rog (sbudon, or to Hold 0
(I) PI’esILmpdOII. W A rebuttable pro.
sumption ‘ -.fl arise that a notice of
IntPvit to deny registration pursuant to
section 3(a)(6) of the Act, a notice of
Int t to cancel registration pursuant
to 1aetl &bXl) of the Act, or a
notice of Intent to hold a hearing to
determine whether the registration
should be fled or denied, as ap-
propriate. shall be tuned. upon a do.
tw ” ”- ” by the A 1nlstra$o? that
the pesth!1’ 4 e meets or exceeds any of
the erltirin for risk set forth I pars.
vlph (aX3) of this section. Upon such
determination, the A inistrstor
shaLl tasue notice by certiflad mail to
the applicant or registrant, as the case
may be. stating that the a ppW ”t or
registrant has the opportunity to
submit evidence In rebuttal of such
presumption In a cordance with pars.
graph a)(4) of this section. The appli-
cant or registrant shall have forty-five
35
— ; —
-------
LABELIIM3 BF JIBF7€W1S ¶IHE RIFRA, AS A? NLED
APPENDIX IV-2
.Ininediately
following
product rime
I7B4
LABEL ‘EF 74ENT
APPLICABILIIY
OF RF UIRE74E}TP
PIACEI4EN’r ON LABEL
RE UIRED
PREPERRED
1
Product name
All products
Front panel
Center tront
panel
COMMEWIS
2
Canpe y name
and address
All products
Ncwie
Bottcin front
panel or end
of label text
.Tf r 1strant 18 not the producer, must
be qualified by “Packed for . . .,“
“Distributed
3
Net contents
All products
None
Bottctii front
panel or end
of_label_text
by. . .,“ etc.
t’ y be in metric units In addition to
U.S. units
L i
‘EPA Reg. No.
All products
None
Front panel
Mist be In similar type size and run
5
‘EPA ‘Eat. No.
All products
None
Front panel,
ninediately
before or
following
Reg.No.
parallel to other type.
?‘ y appear on the container Instead of
the label.
--
—
.Ingreciients
statement
All products
Front panel
Text must run parallel with other text
on the panel.
6B
Pounds/gallon
statement
Liquid producls
ere dosage
given as lbs.
al/unit area
Front panel
birectly below
the main
IngredIent8
statement
7
Front panel
precautionary
statements
All products
Front panel
All front panel precautionary statements
nust be grouped together, preferably
blocked.
7A
Keep Out of Reach
of Children
(Child hazard
All products
Front panel
Above signal
word
Note type size requirements.
lB
warning)
Signal word
All products
Front panel
Imnedlately
below child
hazard
- warning
Note type size requirements.
-------
APPENDIX P1-2 (continued)
.I N
LABEL ‘EF 74ENT
APPLICABIL IY
OF R.EX UIRE74ENT
PLACEIIENT ON LABEL
CCt4MEN 1 IS
RF JIBED
PR PERRFD
7C
Skull & cross-
bones and word
FOISON (in red)
All products
which are Cat-
egory .1 based
on oral, der-
n l, or Inhala-
tion_toxicity
Front panel
Both in close
proximity to
sl,gnal word
71)
Statement of
practical
treathient
All products
in Categories
1, .11, and III
Category 1:
Front panel
unless refer-
ral 8tatanent
18 used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
for all.
.
7E
Referral
stat nent
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
Front panel
8
Side/back panel
precautionary
stat nents
All products
None
¶Ibp or side
of back panel
preceding
direct ions
for use
!btlat be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
5A
Hazards to
humans and
dai est1c
animals
All products
in Categories
1, II , and ILl
None
Same as above
Must be preceded by appropriate signal
rd.
BB
‘Envirorinental
hazards
All products
None
. Same as above
‘Envirorinental hazards include bee
caution where applicable.
-------
APPEM)IX .IV-2 (continued)
Storage and
disposal block
.i.ri the
directions
for use
I mmediately
before
specific
directions
for use or
at the end of
directions
for use
1 Tt N
8C
LABEL ‘EF NENT
Physical or
APPLICABILrIY
OF BE1 IJIRE74ENT
All pressurized
PIACR1 4T ON lABEL
COMMEN!LS
REQUIRED
None
PREI’EiREJ )
Sane as above
chemical
hazards
products, others
with flash
points under
150°F
9A
Restricted
block
All restricted
products
1t center
of front
penel
Preferably
blocked
•Includes a statement of the terms of
restriction. The words “RF SThIC ]) USE
PESTLCIDE” must be same type size as
signal word.
9C
Misuse
statement
All products
.Iniuedlately
following
heading of
directions
for use
1OA
Reentry
a tatenent
All
cholinesterase
inhibitors
•In the
direct ions
for use
•Imediate ly
after misuse
atatenent
All products
Mist be set apart and clearly distin-
guishable fran fran other directions
for use.
101)
Directions
for use
All products
None
None
May be in metric as well as U.S. units
-------
Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F: or if there is a
flashback at any valve
opening.
B. F].ashpoint above 20°F
and not over 80°F: or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
II. Non—Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
F.xtremelv flammable.
Contents under pressure.
Keen away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause burstinq.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause burstina.
Extremely flammable. Keen
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
—70—
-------
Appendix IV—4
STORAGE AND DISPOSAL INSTRUCTIONS FOR PF.STICTDES
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 STflRAC E AND DISPOSAL. Products
intended solely for domestic use need not include the heading
“STORAGE AND DISPOSAL.” The STORAGE AND DISPOSAL headina
must appear in the minimum type size listed below:
I
J
Required type size
I
ISize of label
I
for the heading
I
Ifront panel in
I
STORAGE AND DISPOSAL
I
Isguare inches
I
(all capitals)
I
I
I
110 and under
6 point
I
lAbove 10 to 15
.
8 point
I
lAbove 15 to 30
10 point
I
lOver 30
12 point
I
I
.
I
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. Storage Instructions :
All product labels are reauired to have aoprooriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storaqe instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples cou]d he temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminatinq substances or media.
2. Physical requirements of storage which rniqht adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closina procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
—71—
-------
Appendix IV—4
(continued)
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leakinq 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
durina storaqe to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
B. Pesticide Disposal Instructions :
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, “Do not contaminate water, food,
or feed by storage or disposal.”
2. Except those products intended solely for domestic use,
the labels of all oroducts that contain active ingredients
appearing on the “Acutely Hazardous” Commercial Pesticide
Products List (RCRA “E” List) at the end of this apoendix
or are assiqned to Toxicity Cateqory I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity (ateqory I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
“Pesticide wastes are acutely hazardous. Imorooer dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance.”
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the “Toxic” Commercial Pesticide Products
List (RCRA “F” List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFP
261 for a hazardous waste must bear the following pesticide
disposal statement:
—72—
-------
Appendix IV—4
(continued)
“Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
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 quidance.”
Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
“Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposa]
facility.”
3. Products intended for domestic use only must bear the
following disposal statement: “Securely wrap oriqinal
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
INon —aerosol products I Do not reuse container (bottle, can, jar).
( bottles, cans, iars)I Rinse thoroughly before discarding in trash.I
INon—aerosol products I Do not reuse baq. Discard baa in trash.
I(baas) I
IAerosol products I Replace cap and discard containers in
I trash.’ Do not incinerate or puncture.
—73—
-------
Appendix IV-4
(continued)
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type Statement
IMetal I Triple rinse (or eauivalent). Then offer I
Icontainers I for recycling or reconditioning, or øuncturel
I(non—aerosol) I and dispose of in a sanitary landfill, or hyl
I I other procedures approved by state and locall
I I authorities. I
IPlastic containers Triple rinse (or equivalent). Then offer I
I I for recycling or reconditioninq, or puncturel
I I and dispose of in a sanitary landfill, or I
I I incineration, or, if allowed by state and I
local authorities, by burninq. If burned, I
I stay out of smoke. I
IGlass containers Triple rinse (or equivalent). Then dispose I
I of in a sanitary landfill or by other I
I approved state and local procedures. I
IFiber drums Completely empty liner by shaking and I
Iwith liners tapping sides and bottom to loosen clinging I
I particles. Empty residue into application I
I I equipment. Then dispose of liner in a I
I sanitary landfill or by incineration if
I I allowed by state and local authorities.
I I If drum is contaminated and cannot he I
reused 1 , dispose of in the same manner. I
Ipaper and r Completely empty bag into application I
Iplastic bags I equipment. Then dispose of empty bag in I
I I a sanitary landfill or by incineration, I
I or, if allowed by State and local
I I authorities, by burning. If burned, stay I
I out of smoke. I
ICompressed gas
Icylinders
Return empty cylinder for reuse (or
similar wording) I
1/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
—74—
-------
Appendix IV—4
(continued)
Pesticides that are hazardous wastes under 40 C ’R 761.33(e) and (f)
when discarded.
“ Acutely Hazardous” Commercial Pesticides (RCRA “F” List)
Active Ingredients, (no inerts) :
Acrole in
Aid icarb
Aidrin
Allyl alcohol
Aluminum phosphide
4—Aminopyrid irie
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p—Chloroani]. me
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2—Cyclohexyl—4 , 6-dinitrophenol
Dieldrin
0,0—Diethyl S—r2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di—Syston)
0,0—Diethyl 0—pvrazinyl hosphorothioate (Zinophos)
Dimethoate
0,0—Dimethyl 0—p-nitrophenvl phos horothioate (methyl parathion)
4,6—Diriitro—o—cr sol and salts
4,6—Din itro—o—cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothal 1
Endrin
Famph u r
Fluoroacetamide
Heptachior
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomyl
alpha—Naphthylthiourea (ANTtJ)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
—75—
-------
Appendix IV-4
(continued)
“ Acutely Hazardous” Commercial Pesticides (RCRA “F” List)
Active Inqredients Continued :
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Proparqyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
O,O,O,O—Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Th iofanox
Toxaphene
War far in
Zinc phosphide
—76—
-------
Appendix IV-4
(continued)
“ Toxic” Commercial Pesticide Products (RCRA “F” List)
Active Ingredients :
Ace tone
Acrylonitrile
Am i t role
Benzene
Bis(2—ethylhexvl)pthalate
Cacodylic acid
Carbon tetrachlorjde
Chioral (hydrate)
Chiordane (technical)
Chioroben zene
4 —Chi oro—m—cresol
Chloroform
o-Chlorophenol
4—Chloro—o-toluidjne hydrochloride
Creosote
Cresylic acid
Cvclohexane
Decachlorooctahydro-1,3,4_metheno_2H_cyc] .obuta [ c,d]_pefltalefl_?_ofle
(kepone, chiordecone)
1, 2—Dibromo—3-ch].oropropa e (DBCP)
Dibutyl phthalate
S—3,3—(Dichloroally]. diisopropylthiocarbamate (diall.ate, Avadex)
o-Dichlorobenzene
p—Dichlorobenzene
Dichlorodjfluoromethane (Freon l2 )
3 ,5—Dichloro—N—(1,l—tiirnethyl—2—propyny].) benzamide (pronamide,T erb)
Dichioro diphenyl. dichioroethane (DDD)
Dichioro diphenyl trichioroethane (DDT)
Dichlorethyl ether
2,4—Dichiorophenoxyacetic, esters and salts (2,4—!))
1, 2—Dichloroprooane
1, 3—Dichloro ropane (‘relone)
Dimethyl phthalate
Fthyl acetate
Ethyl 4,4’—dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (F DB)
Ethylene dichioride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachiorocyclopen tad iene
Hexachloroethane
Hydrofluoric acid
—77—
-------
Appendix IV-4
(continued)
“ Toxic Commercial Pesticide Products (RCRA “F” List)
Active Inqredi.ents ?
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Me r Cu ry
Methyl alcohol
Methyl bromide
Methyl chloride
2,2’—Methylenebis (3,4,6—trichiorophenol) (hexachiorophene)
Methylene chloride
Methyl ethyl ketone
4—Methyl—2—pentanone (methyl isobutyl ketone)
Naphthalene
Ni trobenzene
p—Ni trophenol
Pentachioroetharie
Pentachloronitrobenzene (PCNB)
Pent a ci o roph e nol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichl.oride
Pyridine
Resorcinol
Saf role
Selenium disulfide
Si 1 vex
1,2,4, 5—’retrachlorobenzene
1,1,2, 2—Tetrachloroethane
Tetrachioroethylene
2,3, 4,6—’retrachlorophenol
Thiram
To 1 ue n e
1,1 ,1—Trichloroethane
Prichioroethylene
Trichioromonofluoromethane (Freon li®)
2,4, 5—Trichiorophenol
2,4,6—Trichiorophenol
2,4,5—Trichiorophenoxyacetic acid (2,4,5—T)
Xyiene
—7 R —
-------
Appendix IV—4
(continued)
“ Toxic” Commercial Pesticide Products (RCRA “F” List)
Inert Inqredients :
Acetone Formaldehyde
Acetonitrile Formic acid
Acetophenone Isobutyl alcohol
Acrylic acid Meleic anhydride
Aniline Methyl alcohol (methanol)
Benzene Methyl ethyl ketone
Chlorobenzene Methyl methacrylate
Chloroform Naphthalene
Cyclohexane Saccharin and salts
Cyclohexanone Thiourea
Dichiorodifluoromethane (Freon l2 ) Toluene
Diethyl phthalate 1,1, 1—Trichioroethane
Dime thyl amine 1,1, 2—Trichioroethane
Dimethyl phthalate Trichiorofluoromethane (Freon 11 )
1,4—Dioxane Vinyl chloride
Ethylene oxide Xylene
—7q—
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