GUIDANCE FOR THE
REREGISTRATION OF MANUFACTURING-USE
AND CERTAIN END-USE PESTICIDE PRODUCTS
CONTAINING
PROPACHLOR
(019101)
CASE NUMBER 177
CAS 1918-16-7
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D. C. 20460
December 1984
540/RS-86-116
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TABLE OF CONTENTS
'Introduction 1
•I. Regulatory Position and Rationale 4
ill. Requirement for Submission of Generic Data 32
•III. Requirement for Submission of Product-Specific
Data 35
•IV. Submission of Revised Labeling and Packaging
•Information 60
A. Label Contents 60
1. Product Name 60
2. Company Name and Address 60
3. Net Contents 60
4. Product Registration Number 60
5. Producing 'Establishment
Registration Number 61
6A .Ingredient Statement 61
6B Pounds Per Gallon Statement 61
7. Front Panel Precautionary Statements 61
7A Child Hazard Warning Statements 61
7B Signal Word 61
7C Skull and Crossbones and Word Poison 62
7D Statement of Practical Treatment 62
TE Referral Statement 62
8. Side/Back Panel Precautionary Labeling 62
8A Hazard to Humans and Domestic Animals 62
8B 'Environmental Hazard 62
8C Physical or Chemical Hazard 62
9 Misuse Statement 63
10A Storage and Disposal Block 65
10B Directions for Use 65
B. Collateral .Information 65
V. .Instructions for Submission 66
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APPENDICES
Page
,11-1 Guide to Bibliography 67
.11-2 Bibliography 69
,£l-3 RIPRA §3(c)(2)(B) Summary Sheet - 'EPA Form 8580-1 ... 76
•II-4 Certification of Attempt to 'Enter .Into an Agreement
with Other Registrants for Development of Data
'EPA Form 8580-2 77
,111-1 Product Specific Data Report ('End-Use Products). . . .78
JV-1 40 CFR 162.10 Labeling Requirements 80
.IV-2 Table of Labeling Requirements 89
.IV-3 Physical/Chemical Hazards Labeling Statement 92
JV-4 Storage and Disposal Instructions 93
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.INTRODUCTION
The Federal .Insecticide, Fungicide, and Rodenticide Act
(F.IFRA sec. 3(g), as amended in 1978, directs 'EPA to reregister
all pesticides as expedltiously as possible. 'Each registrant
of a manufacturing use product of the active ingredient who
wishes to continue to sell or distribute that product must
apply for reregistratlon.
To carry out this task, we have established the Regis-
tration Standards program, which will review all pesticide
active ingredients first registered before January 1, 1977.
These pesticides will be reviewed in use clusters which are
prioritized on the basis of a ranking scheme giving preference
to pesticides used on food and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an Identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
Insufficient. Our reassessment results in the development
of a regulatory position, contained in this document, on
each pesticide and its uses. Based on the regulatory position,
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 poses no potential
adverse effects to human health or 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 formulated (end use) products that contain
the active ingredient. .If we find serious concerns, we will bring
formulated products under the provisions of the Registration
Standards program to the extent necessary to protect the public.
'EPA has the authority under F.IFRA §3(c)(2)(B) to require
that registrants submit data that will answer our questions
regarding the hazard that may result from the intended use
of the pesticide under review. Further, §3(c)(2)(B) provides
that these data are to be submitted by those registrants
who do not qualify for the formulator's exemption [F.IFRA
§3(c)(2)(D)3. Normally, this means that the registrants who
are responsible for filling the data gaps are the manufacturing
use product producers (basic suppliers of the active ingredient).
However, end use producers will not qualify for the formulator's
exemption if the source of their active ingredient: (1) is
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not registered with 'EPA, and/or (2) is produced by the regis-
trant's firm, or a firm which has ownership in common with
the registrant's firm. These end use producers can qualify
for the formulator's exemption if they change their source of
supply to a registered source, provided the source does not
share ownership In common with the registrant's firm. .If the
end use product registrant decides to switch sources, a new
Confidential Statement of Formula, 'EPA Form 8570-4, must be
submitted to the appropriate Product Manager within 90 days
of receipt of this Guidance Document. The chart on the
following page shows what is generally required of those who
do and do not qualify for the formulator's exemption in the
Registration Standards program.
•If you decide to request the Agency to cancel the regis-
tration of any of your products subject to the reregistration
requirements of this Guidance Document, please notify the Product
Manager named in the cover letter, within 90 days from the
receipt of this document, that you wish to voluntarily cancel
the registration(s) . ,If you decide to maintain your product
registration (s ), you must provide the information described in
the following pages within the timeframes outlined. 'EPA will
issue a notice of intent to cancel or suspend the registration
of any currently registered product If you fail to comply
with the requirements set forth in this Guidance Document.
are reminded that F.I PR A sec. 6(a)(2) requires you at
any time to submit factual information raising concerns of
possible unreasonable adverse effects of a pesticide. You
should notify the Agency of interim results of studies In
progress if those results show possible adverse effects.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
,1. Products That Do Not Qualify
For The Formulator 's 'Exemption
A. Single Active .Ingredient
Products*
These products must be reregis-
tered. To obtain rereglstration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
B. Multiple Active .Ingredient
Products
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described In the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
,11. Products That Do Qualify For
The Formulator fs ^Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, including but not
limited to the Label .Improvement
Program and special intent
to cancel notices.
» 'End use products of registrants who also produce a manufacturing
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified In the Guidance
Document for manufacturing use product(s). Such end use products
will be subject to the labeling changes required for products In ".II"
above. .If there are no manufacturing use products registered by any
company end use products will be required to be reregistered.
NOTE: .If all registrants In ".I" above fail to meet the requirements In
,I-A and B above, then the registrants in ".II" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in .I-A and B.
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I. REGULATORY POSITION AND RATIONALE
A. INTRODUCTION
This Registration Standard describes the regulatory position and rationale
of the Environmental Protection Agency ("the Agency") for all registered
manufacturing-use products (MUPs) containing propachlor as the sole active
ingredient. The Agency bases its position and rationale on an evaluation
of all such products and Section 3, 24(c) and intrastate uses registered
for propachlor. End-use products (EUPs) are reviewed only when there are
no MUPs registered or when the standard imposes requirements of significant
changes in the label. Mixtures are included only when there are require-
ments for significant changes in the label. After briefly describing the
chemical and its uses, this chapter presents the regulatory position and
rationale, the criteria for registration, acceptable ranges and limits,
labeling requirements and the tolerance reassessments.
B. DESCRIPTION OF CHEMICAL
Propachlor is the accepted common name for the compound: 2-Chloro-N-
isopropylacetanilide as determined by the British Standards Institution,
International Organization for Standardization, and the Weed Science
Society of America. Propachlor is marketed under the trade name Ramrod®,
and other names such as: Bexton® and CP 31393®. The Chemical Abstracts
Service (CAS) Registry number is 1918-16-7. The Office of Pesticide
Programs' EPA Chemical Code Number is 019101.
Propachlor is a light tan solid at room temperature and has a pungent odor.
The empirical formula is CuH^ClND, and its molecular weight is 211.70.
The boiling point is 110°C at 0.3 mm Hg. Propachlor is soluble in most
organic solvents and in water (at 23°C) to 693 ppm.
Propachlor is registered for use as a selective preemergence alpha-chloro-
acetamide type herbicide for the control of germinating annual grasses and
broadleafed weeds. Propachlor is mainly applied as a preemergence broadcast
spray or banded ground application, and only one application is allowed
per year. In addition, aerial application of propachlor is allowed.
Propachlor is absorbed mainly by germinating shoots, then is translocated
throughout the plant and accumulates in the vegetative parts where it
acts by inhibiting protein synthesis.
Propachlor was patented by the Monsanto Chemical Company (US Patent No.
2,863,752) in 1958 and was first registered for use in 1965. Technical
propachlor is being produced in the United States by Monsanto Agricultural
Products Company of St. Louis, Missouri.
Propachlor is available as a technical material, at 93.0 % active ingredient
for formulation of propachlor end-use products. Propachlor is available
in granular, wettable powder, and flowable liquid concentrate formulations.
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C. REGULATORY POSITION AND RATIONALE
Based on the review and evaluation of all available data and other relevant
information on propachlor, the Agency has made the following determinations:
1. The available data are insufficient to show that any of the risk
criteria listed in (5 162.11(a) of Title 40 of the U.S.Oode of
Federal Regulations have been met or exceeded for the uses of
propachlor at the present time.
Rationale: There are no valid long term chronic toxicitv data for
propachlor. Studies indicate that propachlor is structurally similar
to alachlor which is oncoaenic in laboratory rats and mice. Data on
prcoachlor show that it is corrosive to the eye with corneal ooacitv
irreversible after 7 days. Further, Propachlor has been shown to be
hiahly toxic to coldwater fish, highly to moderately toxic to warm-
water fish and hiohlv to moderately toxic to freshwater invertebrates.
In addition to the extensive subchronic and chronic toxicitv data
gaps, there are also residue chemistry and environmental fate data
gaps. Because the existinq data are insufficient to show that any
of the risk criteria have been met or exceeded, the Agency is not
initiating a Special Review at this time.
The most appropriate regulatory action is to move quickly to fill
the data aaps. Then the Agency will make a determination as to the
future registerability of the affected uses.
2. MUPs and ElTPs containinq propachlor must bear Toxicity Category I
hazard statements. In addition, all EUPs must bear label statements
requiring mixers, loaders, and applicators to use protective clothing
and equipment. Registrants must revise the labelina of MUPs and EUPs
as specified in the "Required Labeling" section on products released
for shipment as of September 1, 1Q85.
Rationale: Primary eye irritation data on propachlor reviewed by the
Agency show corrosivity and corneal opacitv not reversible within seven
days in rabbits. If propachlor came in contact with the eyes, it
could cause irreversible eye iniury to man. Propachlor may also
induce photosensitivity or photosensitization due to the presence
of aniline in its composition.
3. The Agency will prohibit the aerial application of propachlor and
require a statement on the label of products containing propachlor
stating that aerial application is not permitted.
Rationale: The Agency is concerned about exposure to non-taraet species
as a result of increased drift (over ground application) from aerial
application. Drift from the site of application could result in the
following:
a. Irreversible eye damage to man and possibly photosensitivitv
or photosensitization due to the presence of aniline in
propachlor's composition.
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b. Acute toxicitv to coldwater fish, warrnwater fish and to fresh-
invertebrates.
Further, aerial application of propachlor is currently a minor
method of application and the prohibition of aerial application
would most likely have a minimal economic impact on the farming
conmunitv.
4. The Agency is requiring critical product chemistry, environmental
fate and chronic toxicitv data on propachlor as soon as possible.
Once the Aqency has evaluated these additional data, it will determine
if EPA should initiate the Special Review process.
Rationale: the Aaency has identified the followinq potential adverse
effects on man:
a. Prooachlor is structurally similar to alachlor which is onccoenic
in laboratorv rats and mice,
b. There is a hiqh probability that propachlor will contaminate
ground water because of its solubility and mobility in sandy
soils low in organic matter.
5. The Agency will not approve any new uses (Section 3) or 24(c)
registrations for propachlor until data have been received and
reviewed.
Rationale: Extensive data gaps exist in the areas of chronic toxicity
subchronic toxicity; environmental fate? and residue chemistry
for propachlor. Until the Agency receives and reviews the data
reouired in this guidance package, it cannot fully assess the
potential hazards of increased and/or new uses of propachlor.
6. The Agency will consider a Section 1R exemption for propachlor on a
case-by-case basis.
Rationale: Emergency exemption to use propachlor by a Federal or State
agency will only be qranted after strinaent review of each pest
outbreak shows that the temporary application of propachlor will not
cause adverse effects to non-target species and the ecosystem.
7. The Agency will not grant any pending or new tolerances for propachlor
until data have been received and reviewed. Then the Aqency can deter-
mine whether the new data support the tolerances.
Rationale: While the current TMRC utilizes only 5.2fi% of the ADI, a full
tolerance reassessment has not been ccnroleted by the Agency, because
of certain residue chemistry and toxicity data qaps. In order to
review tolerances, the Agency is requiring data to fill existinq gaps.
8. New and /or amended environmental hazard precautions are being imposed
for MUPs and FUPs to reflect the chemical's potential adverse effects
to non-target organisms. (Refer to Section F. REQUIRED IABELING)
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Rationale: The data base for acute aquatic toxicity shows that propachlor
is highly toxic to coldwater fish, highly to moderately toxic to warm-
vater fish and highly to moderately toxic to freshwater invertebrates.
However, due to gaps in environmental fate data, the Agency cannot ade-
quately assess this chemical's effects on aquatic species' populations.
While a Special Review is not warranted at this time, the Agency is
imposing warning statements on MUP and EUP labels to reduce the
hazards to non-target organisms, until such time as the necessary data
are received and reviewed.
Regarding the potential effects on endangered species, the Agency
is not taking any specific action under this document. Rather, the
Agency is pursuing this matter under a -"cluster approach" with other
pesticides of similar uses. After reviewing the cluster, the Agency
plans to notify (By early 1986) the states' agricultural extension
offices of endangered species labeling restrictions and precautions.
Then these offices will provide appropriate notification to the
users of propachlor.
9. Available data are insufficient to fully assess the environmental fate
of propachlor and the exposure of humans and other non-target organisms
to propachlor.
Rationale: In the ecosystem, propachlor is adsorbed by soil colloids.
Microbes are the primary factor in the breakdown of propachlor in
soils. It's loss from photodecomposition and/or volatilization are
low. Propachlor's solubility rate is high and it is very mobile in
sandy soils low in organic matter.
However, environmental fate data gaps exist for propachlor in
degradation, photodegradation, soil dissipation, rotational crops
(confined), fish accumulation and are only partially filled for
aerobic soil metabolism and leaching data requirements.
10. The Agency has designated for further study, certain chemicals
including propachlor which may have a potential to enter ground water
supplies in the U.S. based on such factors as chemical structures,
solubility and use patterns. Propachlor was included in the May
1984, Data Call-in for ground water. Nbntheless, the Agency is
requiring additional data to evaluate propachlor's potential to
contaminate ground water.
Rationale: There is a high probability that propachlor will contaminate
ground water because of its solubility and mobility in sandy soils
low in organic matter. The Agency requires the following fate
data: hydrolysis (S161-1), photodegradation ($161-2, 161-3), soil
metabolism (js 162-1, 162-2), mobility (18163-1), and field dissipation
(§164-1). Until such data are submitted and evaluated, EPA cannot
assess propachlor's potential to contaminate ground water. Data
were submitted recently by a registrant in response to the May 1984
Data Call-in Notice. They were reviewed by the Agency and were
declared insufficient in meeting ground water data requirements.
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11. The Agency is not requiring a reentry interval for currently
registered uses at this tijne.
Rationale: While this chemical is in Toxicity Category I on the
basis of corrosivity and corneal opacity, The Agency is not requiring
a reentry interval at this time. Propachlor is mainly applied as a
preemergence broadcast spray or banded soil application and not
applied as a foliar spray. Only one application is allowed per
year. Because of the application methods used for propachlor, it
is unlikely that workers would be in the field 24 hours after the
application of the pesticide.
12. Manufacturing-use pesticide products containing propachlor as a sole
active ingredient may be registered for sale, distribution, formulation
and use in the United States, subject to the terms and conditions
specified in this document.
Rationale: Registrants must provide and agree to develop additional
data, as specified in the tables of this guidance document, to
maintain existing registrations.
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D. CRITERIA FOR REGISTRATION UNDER THIS DOCUMENT
To be subiect to this guidance document, manufacturing-use products must
meet the following conditions:
1. Contain propachlor as the sole active ingredient and,
2. Conform to the acute toxicity limits, product composition, and
use pattern requirements listed in Section E of this document.
Registration of products subject to this document must comply with all terms
and conditions described in it, including commitment to fill data gaps on a
schedule acceptable to EPA and consistent with that required of the present
registrant. All registrants and applicants for registration under this document
must follow the instructions contained in this document and complete and submit
the appropriate forms within the specified time.
E. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
Technical grade products must contain at least 93.0 percent propachlor as the
sole active ingredient. Each manufacturing-use product formulation proposed
for registration must be fully described with an appropriate certification of
limits. In addition, the active ingredient found in the manufacturing-use
propachlor products must be substantially similar to that in currently regis-
tered technical products. Any manufacturing-use product not meeting these
requirements will be considered a new product and will not be registerable
under this guidance document.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade and manufacturing-
use products containing propachlor, provided that the product labeling
bears appropriate precautionary statements for the acute toxicity category
in which each product is placed.
3. Use Patterns
To be registrable under this Standard, manufacturing-use products containing
propachlor must be labeled for formulation only into end-use products only
for the commodities listed below. The attached index entry lists all
registered uses, as well as approved maximum application rates and fre-
quencies.
Propachlor is registered for use as a preemergence herbicide on corn (all
types), soybeans (seed only), grain sorghum (milo), green peas, pumpkins,
cotton and flax. In corn, propachlor can also be applied as an early post-
emergence control. Grain sorghum is the largest use site for propachlor.
Corn is the second largest use site for propachlor.
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F. REQUIRED LABELING
All technical grade, MUPs, and EUPs containing propachlor must bear appro-
priate labeling as specified in 40 CFR $ 162.io. Other portions of this
guidance package contain specific information regarding label requirements.
In addition to the requirements stated in 40 CFR $ 162.10, the following
information must appear on the labeling:
1. Manufacturing-Use Product Statements
All products intended for formulation into end-use products must
bear the following statement:
"DANGER. Corrosive, causes irreversible eye damage. Harmful if
swallowed or absorbed. Do not get in eyes or on clothing.
Wear goggles, face shield or safety glasses".
"Do not discharge effluent containing this product directly into
lakes, streams, ponds, estuaries, oceans or public waters unless
this product is specifically identified and addressed in a National
Pollutant Discharge Elimination System (NPDES) permit. Do not
discharge effluent containing this product into sewer systems with-
out previously notifying the sewage treatment plant authority.
For guidance, contact your State Water Board or Regional Office
of the Environmental Protection Agency".
2. End-Use Product Statements
The following human hazard statement must appear on all EUP labels:
"DANCER. Corrosive, causes irreversible eye damage. Harmful if
swallowed or absorbed. Do not get in eyes or on clothing".
a. Granular Products
The following environmental hazard statement must appear on all
granular EUP products:
"This pesticide is toxic to fish. Do not apply directly to water.
Runoff from treated areas may be hazardous to aquatic organisms
in neighboring areas. Do not contaminate water by cleaning of
equipment or disposal of wastes, m case of spills, collect for
use or properly dispose of granules".
in
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b. Non Granular Products
The following environmental hazard statement must appear on all
non granular EUP products:
"This pesticide is toxic to fish. Do not apply directly to water.
Drift and runoff from treated areas may be hazardous to aquatic
organisms in neighboring areas. Do not contaminate water by
cleaning of equipment or disposal of wastes. In case of spills,
collect for proper disposal".
c. The following precautionary statements must appear on all EUP
products:
"Required clothing and equipment for mixing/loading and applying
propachlor":
"One-piece coveralls which have lonq sleeves and long pants con-
structed of laminated fabric as specified in the USDA/EPA Guide
for Commercial Applicators".
"Goggles, face shield, or safety glasses".
"Liquid-proof hat such as a plastic hard hat with a plastic
sweat band".
"Heavy-duty liquid proof rubber (neoprene) work gloves".
"Any article worn while handling propachlor must be cleaned
before reusing. Clothing which has been drenched or has other-
wise absorbed concentrated pesticide from any significant spill
must be disposed of in a sanitary landfill, by incineration, or
if allowed by state and local authorities, by burning. If
burned, stay out of smoke".
"Instead of clothing and equipment specified above, the appli-
cator can use an enclosed tractor cab which provides a filtered
air supply".
Prohibition on Aerial Application
"Do not apply with aerial equipment".
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G. TOLERANCE REASSESSMENT
EPA's assessment of the Acceptable Daily Intake (ADI) for propachlor used
a 90 day feeding study on rats, with a No-Observable-Effeet-Level (NOEL)
.of 13.3 mg/kg or 266.00 ppm. A 2,000-fold safety factor was used and the
ADI was calculated as 0.0067 mgAg/day with a Maximum Permissible Intake
(MPI) of 0.3990 mg/day for a 60 kg person. The current Theoretical
Maximum Residue Contribution (TMRC) for propachlor, based on established
tolerances, is 0.0210 mg/day for a 1.5 kg diet. The percentage of the ADI
utilized is 5.26%.
The Agency is unable to complete a full tolerance reassessment
because the available propachlor residue data do not currently support
the established tolerances listed below. Data on the metabolism of
residues in plants and animals, and on residue storage stability are
required. The additional data will be used to more fully assess dietary
exposure to propachlor and may lead to revisions in the existing tolerances.
Therefore, the Agency will not grant any pending or new tolerances for
propachlor until the required data are submitted.
In the United States, tolerances are currently established in 40 CFR S 180.211
for the combined residues of the herbicide (2-Chloro-N-isopropylacetanilide)
and its metabolites (calculated as 2-Chloro-N-isopropylacetanilide) in or on
the raw agricultural commodities listed below:
Commodities Parts per million
Beets, sugar, roots 0.2
Beets, sugar, tops 1.0
Cattle, fat 0.02
Cattle, meat by-products 0.02
Cattle, meat 0.02
Corn, forage 1.5
Corn, fresh, (sweetHK+CWHR) 0.1
Corn, grain 0.1
Cottonseed 0.1
Eggs 0.02
Flax, seed 3.0
Flax, straw 10.0
Goats, fat 0.02
Goats, meat by-products 0.02
Goats, meat 0.02
Hogs, fat 0.02
Hogs, meat by-products 0.02
Hogs, meat 0.02
Horses, fat 0.02
Horses, meat by-products 0.02
Horses, meat 0.02
Milk 0.02
Peas, pods removed 0.2
Peas, forage 1.5
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Poultry, fat 0.02
Poultry, meat by-products 0.02
Poultry, meat 0.02
Pumpkins ~ 0.1
Sheep, fat 0.02
Sheep, meat by-products 0.02
Sheep, meat 0.02
Sorghum, fodder 5.0
Sorghum, forage 5.0
Sorghum, grain(milo) 0.25
International Tolerances
Presently, there are no tolerances for residues of propachlor in Canada,
Mexico, or in the Codex Alimentarius.
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EPA Index to Pesticide Chemicals
2-CTLORC)^-ISOPROPYIACErANTT .THE*
TYPE PESTICIDE! Herbicide
FORMUIATIONS;
Tech (93%)
G (8.3%, 10%, 13.34%, 18%, 20%, 25%, 26.5%)
"WP (30%, 39%, 48.1%, 65%)
EC (2 Ib/gal)
FIG (3 Ib/gal, 4 Ib/gal)
GENERAL WARNINGS AND ' LIMITATIONS ; A preeroergence, selective, soil active
herbicide. Soil surface should be freshly worked and free of weed top
growth. Sane moisture, as either rain or irrigation, is required soon
after application. Harrowing or rotary hoeing after application may reduce
weed control. Use the lower dosages for sandy soils, the medium dosages
for silt loam soils, and the higher dosages for clay soils or in areas of
heavy weed infestation. Reudce dosages in proportion to band area actually
treated.
Livestock Tolerances ; 0.02 ppm (negligible residue) in eggs, milk, meat,
fat, and meat byproducts of cattle, goats, hogs, horses, poultry, and sheep.
TIME REQUIRED FOR CCKTRDL: Not located.
PfflTOTOXIcnY TO TARGET V/™*?' Malformed growth and severe inhibition of
emerging shoots of weeds.
Y TO "CROPS; Corn - leafing out underground and failure of leaves
to unfurl; soybeans - leaves crinkle and form a heart-shaped appearance.
MODE OF ACTICN; Inhibits root elongation, probably as a result of an
inhibition of auxin-induced cell elongation. Also inhibits protien synthesis
in root tips.
BRCADLEAF WEEDS
amaranth PAEACAA
carpetweed PADABEA
cciuion lambsquarters (b) PBDAEEA
cauion purslane PEDADBA
comon ragweed (b) PSFAEEA
florida pusley • PEMAEBB
groundsel (b) PBPCXAA
ladysthumb, snartweed PEAAGEF
pigweed PAAAABI
shepherd spurse (a) PEKAH3A
wild buckwheat (b) PEAAG3H
(a) Use the higher dosages (464-478; 524-152).
(b) Reduces competition through the use of higher dosages when applied
ijirodiately after planting (524-331, 524-152, 524-153).
*Prcpachlor
Ramrod
Issued: 12-30-83 1-019101-1
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EPA Index to Pesticide Chemicals
2-CHLORD-N-ISOPRCPYLIACErANILIDE
GRASSES AND OTHER MONOOOTS
annual ryegrass PZAAAAI-
barnyardgrass PCAEKBI
broadleaf signalgrass (b) PCAAREI
crabgrass PCABF.V
fall panicum PCamRT
giant foxtail PCAOJEP
^yj*QQ ^j^T9i9 9 FVnf^ip A c^*
green foxtail PCACJEI
sandbur PCAAWA?
yellow foxtail PCACJEI
(b) Reduces conpetition through the use of higher dosages when applied
immediately after planting (524-331, 524-152, 524-153).
Issued: 12-30-83 1-019101-2
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Site, Dosage
and Formulation
(Ib a.i./A)
EPA Index to Pesticide Chemicals
2-CHLCRO-N-ISOPRCTYIACErANTT .THE
Tolerance/ Use, Limitations
AGRICULTURAL CPDPS
Corn, Field
4-6
(20% G)
4-5
(25% G)
3.94-5.78
(26.25% G)
3.9-5.85
(65% WP)
4.0-6.0
(42% F1C)
2-4
(13.34% G)
2.7-1.5
(18% G)
2.41-3.85
(48.1% WP)
3.5-5.5
(31.5% F1C)
0.67-3
(10% G)
1.5-3
(30% WP)
1.46-2.93
(39% WP)
0.69-3
(2 Ib/gal EC)
0.1 ppm (grain) /28006P
1.5 ppm (forage)
Preemergence. Broadcast or band. Apply after
planting prior to emergence of crop or weeds.
Furrow irrigated corn requires incorporation to a
depth of 0.5 to 2 inches. Apply the wettable
powder in 20 gallons of water per acre, and the
flowable liquid concentrate in 15 gallons of water
per acre ty ground and in a minimum of 5 gallons ty
air.
Preemergence. Broadcast or band. Apply after
planting and prior to emergence of crop or weeds.
Do not use on highly organic soils such as peat
or muck. Apply the wettable powder in 20 to 40
gallons of water per acre, and the flowable liquid
concentrate in 15 gallons of water per acre by
ground and in a minimum of 5 gallons by air.
Formulated with atrazine.
Preemergence. Broadcast or band. Apply after
planting and prior to emergence of crop or weeds.
Plant seed at least 1.75 inches deep or injury may
result. Do not use on sand or loamy sand soils,
or on soils with less than 1 percent organic matter.
Apply the wettable powder and enulsifiable concen-
trate in 25 to 40 gallons of water per acre. If
initial seeding fails, soybeans (seed crop only),
field corn or grain sorghum may be replanted in
treated soil. Thoroughly rework soil before
replanting. Do.not replant other crops within 4
months after application.
Formulated with linuron.
Issued: 12-30-83
1-019101-3
16
-------
Site, Dosage
and Formulation
(Ib a.i./A)
EPA Index to Pesticide Chemicals
2~CHLORCMI-ISOPROPYIACErANTT .IDE
Tolerance, Use, Limitations
AGRICULTURAL CROPS
Corn, Field
(continued)
5.6
(20% G)
5
(25% G)
5.2-5.85
(65% WP)
5.25-6.0
(42% F1C)
3.6-4.5
(18% G)
2.41-3.85
(48.1% WP)
3.5-5.5
(31.5% F1C)
2.47-3.9
(65% WP)
2.5-4.0
(42% F1C)
4.55-5.85
(65% WP)
2.41-3.85
(48.1% WP)
2.5-4.0
(42% F1C)
Premergence. Broadcast or band application to
lister or deep furrow planted corn. Apply after
planting and prior to emergence of crop or weeds.
Heavy rain following application will reduce ef-
fectiveness on the top and sides of the furrow.
Apply the wettable powder in 20 or more gallons
of water per acre, and the flowable liquid
concentrate in 15 or more gallons of water per
acre by ground, and in a minimum of 5 gallons
by air.
Preemergance. Broadcast or band application to
lister or deep furrow planted corn. Apply after
planting and prior to emergence cf crop or weeds.
Heavy rain following application will reduce ef-
fectiveness on the top and sides of the furrow.
Apply the wettable powder in 20—40 gallons of
water per acre, and the flowable liquid concentrate
in 15 or more gallons of water per acre by ground
and in a minimum of 5 gallons by air.
Formulated with atrazine.
Preemergence. Broadcast or band. Tank mix with
atrazine. May be applied immediately after planting
until weeds or grasses reach the 2-leaf stage.
Apply the wettable powder in 20 or more gallons
of water per acre, and the flowable liquid concen-
trate in 15 or more gallons water per acre by
ground, and in a minimum of 5 gallons by air.
Early postemergence. Broadcast. Apply before
grasses reach the 2-leaf stage.
Early postemergence. Broadcast. Apply before
grasses and broadleaf weeds reach the 2-leaf
stage. Apply the wettable powder in 20 to 40
gallons of water per acre, and the flowable
liquid concentrate in 15 or more gallons water
per acre by ground, and in a minimum of 5 gallons
by air. . '
Formulated with atrazine (WP) and tank mixed with
atrazine (FL/C).
Issued: 12-30-83
1-019101-4
i -?
-------
EPA Index to Pesticide Chemicals
Site, Dosage
and Formulation
(Ib a.i./A)
Tolerance, Use, Limitations
AGRICULTURAL CROPS
Corn (hybrid seed
crop)
4-6
(20% G)
4-5
(25% G)
3.94-5.78
(26.25% G)
3.9-5.85
(65% WP)
4.0-6.0
(42% F1C)
4.75
(8.3% G)
2.7-4.5
(18% G)
2.41-3.85
(48.1% WP)
3.5-5.5
(31.5% F1C)
2.47-3.9
(65% WP)
2.5-4.0
(42% F1C)
5-6
(20% G)
5
(25% G)
N.F. (seed)
1.5 ppcn (forage)
Preemergence. Broadcast or band. Apply after
planting and prior to emergence of crop or
weeds. Furrow irrigated corn requires incorpor-
ation to a depth of 0.5 to 2 inches. Apply the
wettable powder in 20 gallons of water per acre,
and the flowable liquid concentrate in 15 gallons
of water per acre by ground and in a minimum
of 5 gallons per acre by air.
Preemergence. Band application. Apply at
planting.
Formulated with parathion.
Preemergence. Broadcast or band. Apply after
planting and prior to emergence of crop or weeds.
Do not use on highly organic soils such as peat
or muck. Apply the wettable powder in 20 to 40
gallons of water per acre, and the flowable
liquid concentrate in 15 gallons of water per
acre by ground and in a minimum of 5 gallons by
air.
Preemergence. Broadcast or band. Tank mix with
atrazine. May be applied immediately after
planting until weeds or grasses reach the 2-leaf
stage. Apply wettable powder in 20 or more
gallons of water, per acre and the flowable liquid
concentrate in 15 gallons of water per acre and
in a minimum of 5 gallons by air.
Preemergence. Broadcast or band application to
lister or deep furrow planted corn. Apply after
planting and prior to emergence of crop or weeds.
Heavy rain following application will reduce ef-
fectiveness on the top and sides of the furrow.
Apply the wettable powder in 20 or more gallons of
Issued: 12-30-83
1-019101-5
18
-------
Site, Dosage
and Formulation
(Ib a.i./A)
EPA Index to Pesticide Chemicals
2H3JLDRCHJ-ISOPROPYIACCTANTT JDE
Tolerance, Use, Limitations
AGRICULTURAL CROPS
Corn (hybrid seed crop) (continued)
5.2-5.85
(65% WP)
5.25-6.0
(42% EL/C)
3.6-4.5
(18% G)
2.41-3.85
(48.1% WP)
3.5-5.5
(31.5% F1C)
4.55-5.85
(65% WP)
2.41-3.85
(48.1% WP)
2.5-4.0
(42% F1C)
Corn, Silage
Corn, Sweet
4-6
(20% G)
4-5
(25% G)
3.94-5.78
(26.25% G)
water per acre and the flowable liquid concentrate
in 15 gallons of water per acre and in a minimum
of 5 gallons by air.
Preemergence. Broadcast or band application to
lister or deep furrow planted corn. Apply after
planting and prior to emergence of crop or weeds.
Heavy rain following application will reduce ef-
fectiveness on the top and sides of the furrow.
Apply the wettable powder in 20 to 40 gallons of
water per acre and the flowable liquid concentrate
in 15 gallons of water per acre in a minimum of
5 gallons by air.
Formulated with atrazine.
Early postemergence. Broadcast.
grasses reach the 2-leaf stage.
Apply before
Early postemergence. Broadcast. Apply before
grasses and broadleaf weeds reach the 2-leaf
stage. Apply in 20 to 40 gallons of water per acrs
and the flowable liquid concentrate in 15 gallons
of water per acre in a minimum of 5 gallons by air.
Formulated with atrazine (WP) and tank mix with
atrazine (F1C).
0.1 ppm (grain and fresh corn (kernels plus cobs /22C05;
with husks removed)) • /15005;
1.5 ppro (forage)
Preemergence. Broadcast or band. Apply after
planting and prior to emergence of crop or weeds.
Furrow irrigated corn requires incorporation to a
depth of 0.5 to 2 inches. Apply the wettable
powder in 20 gallons of water per acre and the
flowable liquid concentrate in 15 gallons of water
per acre by ground and in a minimum of 5 gallons by
air.
Issued: 12-30-83
1-019101-6
19
-------
EPA Index to Pesticide Chemicals
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib a.i./A)
AGRICULTURAL CROPS
Corn, Silage cluster (continued)
3.9-5.85
(65% WP)
4.0-6.0
(42% F1C)
2-4 Preemergence. Broadcast or band. Apply after
(13.34% G) planting and prior to emergence of crop or weeds.
Do not use on highly organic soils such as peat or
2.7-4.5 muck. Apply the wettable powder in 20 to 40 gallons
(18% G) of water per acre and the flowable liquid concentrate
in 15 gallons of water per acre ty ground and in a
2.41-3.85 minimum of 5 gallons by air.
(48.1% WP) . Formulated with atrazine.
3.5-5.5
(31.5% F1C)
2.47-3.9 Preemergence. Broadcast or band. Tank mix with
(65% WP) atrazine. May be applied immediately after planting
until weeds or grasses reach the 2-leaf stage.
2.5-4.0 Apply wettable powder in 20 or more gallons of water
(42% FIG) per acre and the flowable liquid concentrate in
15 gallons of water per acre by ground and in a
minimum of 5 gallons by air.
5-6 Preemergence. Broadcast or band application to
(20% G) . lister or deep furrow planted corn. Apply after
planting and prior to emergence of crop or weeds.
5.0 Heavy rain following application will reduce ef-
(25% G) fectiveness on the top and sides of the furrow.
Apply the wettable powder in 20 or more gallons
5.2-5.85 of water per acre and the flowable liquid concon-
(65% WP) trate in 15 gallons of water per acre by ground
and in a mLniflum of 5 gallons by air.
Issued: 12-30-83 1-019101-7
20
-------
EPA Index to Pesticide Chemicals
Site, Dosage
and Formulation
(Ib a.i./A)
Tolerance, Use, Limitations
AGRICULTURAL -CROPS
Corn, Silage cluster (continued)
5.25-6.0
(42% F1C)
2.6-4.5
(18% G)
2.41-3.85
(48.1% WP)
3.5-5.5
(31.5% F1C)
4.55-5.85
(65% WP)
2.41-3.85
(48.1% WP)
2.5-4.0
(42% F1C)
Corn, Sweet
Cotton
3.94-5.25
(26.25% G)
Flax
4.0
(42.0% F1C)
Preemergence. Broadcast or band application to
lister or deep furrow planted corn. Apply after
planting and prior to emergence of crop or weeds.
Heavy rain following application will reduce ef-
fectiveness en the top and sides of the furrow.
Apply the wettable powder in 20 to 40 gallons of
water per acre and the flowable liquid concentrate
in 15 gallons of water per acre ty ground and in
a minimum of 5 gallons ty air.
Formulated with atrazine.
Early postemergence. Broadcast.
grasses reach the 2-leaf stage.
Apply before
Early postemergence. Broadcast. Apply before
grasses and broadleaf weeds reach the 2-leaf
stage. Apply wettable powder in 20 to 40 gallons
of water per acre and the flcwable liquid concen-
trate in 15 gallons of water per acre by ground
and in a minimum of 5 gallons by air.
Formulated with atrazine (WP) and tank mixed with
atrazine (FL/C).
See Corn, Silage cluster.
0.1 ppm (cottonseed)
Preemergence. Apply after planting and prior to
emergence of crop or weeds.
3.0 ppm (seed)
10.0 ppm (straw)
Preemergence. Broadcast or band. Apply after
planting and prior to emergence of crop or weeds.
Apply in 15 or more gallons of water or liquid
fertilizer per acre and in a ntiniraum of 5
gallons by air.
/28007A?
/28009A;
Issued: 12-30-83
1-019101-8
-------
EPA Index to Pesticide Chemicals
Site> Dosage
and Formulation
(Xb a.i./A)
Tolerance, Use, Limitations
AGRICUUTORAL CROPS
Peas (green) (for
processing only)
3.9-4.88
(65% WP)
4.0-5.0
(42% F1C)
Pumpkins
4.0-6.0
(42.0% F1C)
Sorghum (grain crop)
3.94-5.25
(26.25% G)
4-5
(20% G)
3.9-4.88
(65% WP)
4.0-5.0
(42% FIG)
0.2 ppm (determined after removing any pod /150G9.
present when marketed)
1.5 ppm (forage)
Preemergence. Broadcast. Apply after planting
and prior to emergence of crop or weeds. Apply
wettable powder in 20 or more gallons of water
per acre and flowable liquid concentrate in 15
gallons of water per acre. May be applied by
air in MN only, using at least 5 gallons of water
per acre, no aerial restrictions on flowable
liquid concentrate formulation.
0.1 ppm (pumpkin) /10011
Preemergence. Broadcast or band. Apply
after planting and prior to emergence of crop
or weeds. Apply in 15 or more gallons of
water per acre and in a minimum of 5 gallons by
air. Do not apply to soil with less than 1%
organic matter. Apply once per growing season.
Do not apply within 90 days of harvest.
0.25 ppm (grain) /2400f
5 ppm (forage)
Do not graze or feed forage or silage fron
treated fields to dairy animals. Do not cut
irmature plants for silage.
Preemergence. Broadcast or band. Apply after
planting and prior to emergence of crop or weeds.
Apply the wettable powder in 20 or more .gallons
of water per acre and the flowable liquid concen-
trate in 15 gallons or more water per acre and
in a minimum of 5 gallons by air.
Issued: 12-30-83
1-019101-9
22
-------
EPA Index to Pesticide Chemicals
2-CHjORO-N-ISOPRCPYIACETANILIDE
Site, Dosage Iblerance, Use, Limitations
and formulation
(Ib a.i./A)
AGRICULTURAL CROPS
Sorghum (grain crop) (continued)
4.46-5.25 Preemergence. Broadcast or band. Apply after
(26.25% G) planting and prior to emergence of crop or
weeds. Furrow irrigated corn requires in-
corporation to a depth of 0.5-2 inches.
4.46-5.25 Preemergence. Broadcast to lister or deep furrow
(26.25% G) planted sorghum. Apply after planting and prior to
emergence of crop or weeds. Heavy rains following
5.0 application may reduce effectiveness on top and
(42.0% F1C) sides of the furrow. Apply the flowable liquid
concentrate in 15 gallons or more water per acre
and in a minimum of 5 gallons by air.
3.0-4.0 Preemergence. Broadcast. Tank mix with bifenox.
(42% F1C) Apply after planting but prior to emergence of
eron or weeds. Annlv in 15 or more Gallons o£
«ppj.y arcer planting cut prior TJO emergence or
crop or weeds. Apply in 15 or more gallons of
water per acre.
water per acre
2.93-3.9 Use limited to all areas except CK and TX.
(65% WP) Preemergence. Broadcast. Tank mix with atrazine.
Apply after planting until weeds or grasses reach
the 2-leaf stage. Apply in 20 or more gallons of
water per acre by ground, or in 5 gallons of
water by air. Apply in sprayable fluid fertilizer
only. Do not use on coarse textured soils with
less than 3 percent organic matter.
2.5-4.0 No use restrictions except in IX use only on
(42% F1C) fine textured soils of the Gulf Coast.
Preemergence. Broadcast. Tank mix with atrazine.
Apply immediately after planting but before
emergence of weeds or crop. Apply in 15 or mare
gallons of water or sprayable fluid fertilizer
per acre by ground or in a minimum of 5 gallons
water by air. Do not use on coarse textured
soils with less than 3 percent organic matter.
Issued: 12-30-83 1-019101-10
23
-------
EPA Index to Pesticide Chemicals
2-CHLORD-N-ISOPRCPYIACErANILIDE
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib a.i./A)
AGRICULTURAL CROPS
Sorghum (grain crop) (continued)
2.78-2.93 Preemergence. Broadcast or band. Tank mix
(65% WP) propazine. Apply after planting and prior to
emergence of crop or weeds. Apply wettable
2.5-3.0 powder in 20 gallons of water per acre and the
(42% F1C) flowable liquid concentrate in 15 or more gallons
of water per acre by ground in a minimum of 5
gallons of water by air.
0.69-3.0 Use limited to Great Plains area.
(2 Ib/gal EC) Preemergence. Broadcast or band. Apply after
planting and prior to emergence of crop or weeds.
Plant seed at least 1 inch deep. Do not use on
sand or loamy sand soils, or on soils with less
than 1 percent organic matter. Apply in 25 to 40
gallons of water per acre. If initial seeding
fails, soybeans (seed crop only), field corn or
grain sorghum may be replanted in treated soil.
Do not retreat during the same crop year. Do
not replant other crops within 4 months after
application.
Formulated with linuron.
2.41-3.85 Use of 48.1% WP prohibited in OK.
(48.1% WP)
Preemergence. Broadcast or band. Apply after
3.5-5.5 planting and prior to emergence of crop or
(31.5% F1C) weeds. Do not use on coarse textured soils with
less than 3 percent organic matter. In TX, use
only on the fine textured soils of the Gulf Coast.
Apply wettable powder in 20 to 40 gallons or flowable
liquid concentrate in 15 gallons of water or fluid
fertilizer by ground and a minimum of 5 gallons by
air.
Formulated with atrazine.
Issued: 12-30-83 1-019101-11
24
-------
EPA Index to Pesticide Chemicals
Site, Dosage
and Formulation
(Ib a.i./A)
Tolerance, Use, Limitations
AGRICULTURAL CROPS
Soybeans (seed crop)
3.94-5.25
(26.25% G)
3.9-4.88
(65% WP)
4-5
(20% G)
(25% G)
0.67-3
(10% G)
(2 Ib/gal EC)
N.F. (seed)
Do not graze or feed forage from treated areas.
Do not use seed for food, feed or oil purposes.
Preemergence. Broadcast or band. Apply after
planting and prior to emergence of crop or weeds.
Apply the wettable powder in 20 or more gallons
of water per acre.
/26C22
Preemergence. Broadcast or band. Apply after
planting and prior to emergence of crop or weeds.
Plant seed at least 1.75 inches deep. Do not use
on sand or loamy sand soils, or on soils with less
than 1 percent organic matter. Apply the emulsi-
fiable concentrate in 25 to 40 gallons of water
per acre. If initial seeing fails, soybeans
(seed crop only), field corn, soybeans or grain
sorghum may be replanted in treated soil. Do net
retreat during the same crop year. Do not replant
other crops within 4 months after application.
Formulated with linuron.
AERIAL AND TANK MIX APPLICATIONS
Aerial Acolication
90015(
Refer to
AGRICULTURAL-CROPS
Corn, Field; Corn (hybrid seed crop); Corn,
Silage; Corn, Sweet; Flax; Peas (green) (for
processing only); Pumpkins; Sorghum (grain crop).
Issued: 12-30-83
1-019101-12
25
-------
EPA Index to Pesticide Chemicals
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib a.i./A)
*,
AERIAL AND TANK MIX APPLJCATICKS
Tank Mix 990C3CC
"^^^^^^~ ^" •
— Refer to
AGRICULTURAL CROPS
Corn, Field; Corn (hybrid seed crop); Corn,
Silage? Corn, Sweet; Sorghum (grain crop)
Issued: 12-30-83 1-019101-13
26
-------
EPA Index to Pesticide Chemicals
2-KSLDRD^-ISOPRCPYlACErANTT .IDE
Appendix A
Listing of Registered Pesticide Products by Formulation
93% technical chemical (TC)
2-chlOTO-N-iscpropylacetanilide (019101)
000524-00310
8.3% granular (G)
2-chloro-N-isopropylacetanilide (019101) plus parathion (057501)
000524-O0156
10% Granular (G)
2-chloro-N-isopropylacetanilide (019101) plus linuron (035506)
000352-00334 000524-00289
13.34% cranular (G)
2-chloro-N-isopropylacetanilide (019101) plus atrazine (080803)
000100-00519 000464-00484
18% granular (G)
2-chloro-N-isopropylacetanilide (019101) plus atrazine (080803)
000524-00303
20% granular (G)
2-chloro-N-isopropylacetanilide (019101)
000464-00478 000524-00152 001258-00784 • 002749-OC149
25% granular (G)
2-chloro-N-isopropylacetanilide (019101)
000524-00265
26.25% oranular (G)
2-chloro-N-isopropyiacetanilide (019101)
000524-00280
30% wettable powder (WP)
2M*loro-N-isopropyiacetanilide (019101) plus linuron (035506)
000524-00288
39% wettable powder (WP)
2-chloro-N-isoprcpylacetanilide (019101) plus linuron (035506)
008461-00003
48.1% wettable powder'(WP)
2-chloro-N-isopropylacetanilide (019101) plus atrazine (080803)
000100-00513 000524-00286
65% vettable powder (WP)
2-chloro—N-isopropylacetanilide (019101)
000464-00477 000524-00153 001258-00785 002749-00161
Issued: 12-30-83 1-019101-14
-------
EPA Index to Pesticide Chemicals
2-CHLORD-N-ISOPROPYLACCTANTT .IDE
Appendix A
Listing of Registered Pesticide Products ty Fornulation (continued)
2 Ib/gal emulsifiable concentrate (EC)
2-chloro-N-isopropyLacetanilide (019101) plus linuron (035506)
000352-00345
31.5% flcwable liquid concentrate (F1C)
2-chloro-N-iscoropylacetanilide (019101) plus atrazine (080803)
000524-00328"
42.0% flcwable liquid concentrate (F1C)
2-chloro-N-iscprcpylacetanilide (019101)
000524-00331
Issued: 12-30-83 1-019101-15
28
-------
EPA Index to Pesticide Chemicals
Appendix B
Listing of Conrron and Chemical Names Used in This Entry
" Chemical
Code
035506
057501
080803
080808
104301
Qjinun
Name
Linuron
Parathion
Atrazine
Prcpazine
Bifenox
EPA Acceptable
Cannon/Chemical Name
3-(3,4-dichlorcphenyl)-1-
methoxy-1-jnethylurea
0,0-Diethyl O-P-nitrophenyl
phosphorothioate
2-chloro-4- (ethy lamino) -6-
(isopropy lamino) -s -triazine
2-chloro-4,6-bis(isopropylamino) •
S-triazine
Methyl 5-(2,4-dichlorcphenoxy)-
2-nitrdbenzoate
Issued: 12-30-83
1-019101-16
-------
EPA Index to Pesticide Chemicals
Appendix C
Listing of Registration Nunbers by Site* (Fornulation Codes in Appendix A)
"AGRICULTURAL CROPS
Corn, Field
000100-00513 (WP)
000352-00345 (EC)
000464-00484 (G)
000524-00265 (Gl)
000524-00288 (WP)
000524-00328 (F1C)
001258-00785 (WPl)
008561-00003 (WP)
000100-00519
000464-00477
000524-00152
000524-00280
000524-00289
000524-00331
00274^00149
(G)
(WPl)
(Gl)
(Gl)
(G)
(F1C1)
(Gl)
"000464-00477 (WPO
000524-00153 (WPl)
000524-00280 (Gl)
000524-00328 (F1C)
001258-00785 (WPl)
000100-00519 (G)
000464-00484 (G)
000524-00265 (Gl)
000524-00303 (G)
002749-00149 (Gl)
Corn (Hybrid seed crop)
000100-00513 (WP)
000524-00152 (Gl)
000524-00265 (Gl)
000524-00303 (G)
001258-00784 (Gl)
002749-00161 {WPl)
Corn, Silage
000100-00513 (WP)
000464-00478 (Gl)
000524-00153 (WPl)
000524-00286 (WP)
000524-00331 (F1CI)
Corn, Sweet
000100-00513 (WP)
000464-00478 (Gl)
000524-00153 (WPl)
000524-00286 (WP)
000524-00331 (F1C1)
Cotton
000524-00280 (Gl)
Flax
""000524-00331 (F1C1)
Peas (green) (for processing only)
000464-00477 (WPl)0005^4-00153 (WPl)
Pumbkins
000524-00331 (F1CJ)
000100-00519
000464-00484 (Gj
000524-00265 (G'O
000524-00303 (G)
002749-00149 (Gl)
000352-00334 (G)
000464-00478 (Gl)
000524-00153 (WPl)
000524-00286 (WP)
000524-00303 (G)
001258-00784 (Gl)
002749-00161 (WPl)
000464-00478 (Gl)
000524-00156 (G)
000524-00286 (WP)
000524-00331 (F1C1)
002749-00149 (Gl)
000464-00477 (WPl)
000524-00152 (Gl)
000524-00280 (Gl)
000524-00328 (F1C)
002749-00161 (WPl)
000464-00477 (WPl)
000524-00152 (Gl)
000524-00280 (Gl)
000524-00328 (F1C)
002749-00161 (WPl)
/28006;
/28C05E
/22005A
/150C5A
000524-00331 (F1C1)
/28007A
/28009A
/15009A
* Single active ingredient (S.A.I.) products are identified by 1. The
rest of the products are multiple active ingredients (M.A.I.).
Issued: 12-30-83
1-019101-17
30
-------
EPA Index to Pesticide Chenticals
2-CHLCRO-N-ISOPROPYIACETAtm .TEE
Appendix C
Listing of Registration Nunfcers by Site* (Fonnilation Codes in Appendix A)
(continued)
AGRICULTURAL'CROPS
Sorghum (grain
LOG-00513
crco)
000100-00513 (WP~)
000464-00478 (Gl)
000524-00280 (Gl)
002749-00149 (Gi)
is (seed crop)
3352-00334 (G)
000464-00478 (Gl)
000524-00265 (Gl)
001258-00785 (WP1)
000352-00345 (EC)
000524-00152 (Gl)
000524-00286 (WP)
002749-00161 (WPl)
000352-00345 (EC)
000524-00152 (GI)
000524-00280 (Gl)
002749-00149 (Gl)
000464-00477 (WP!)
000524-00153 (WPl)
000524-00328 (F1C)
000464-00477 (WPl)
000524-00153 (WPl)
001258-00784 (Gl)
002749-00161 (WPl)
/24006A?.
* Single active ingredient (S.A.I.) products are identified by 1.
rest of the products are multiple active ingredients (M.A.I.)
The
Issued: 12-30-83
1-019101-18
-------
,11. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice issued
under the authority of FJFRA sec. 3(c)(2)(B) and describes,
in table format, the data required for maintaining the registra-
bility of each product. Additionally, a bibliography (Appendix
JJW2) is Included that identifies that data considered as part
of the data base supporting this standard. 'EPA has determined
that additional generic data described in this Notice must be
submitted to 'EPA for evaluation in order to maintain in
effect the reglstratlon(s) of your product(s) Identified as
an attachment to the cover letter accompanying this guidance
document. As required by RIPRA sec. 3(c)(2)(B), you are
required to take appropriate steps to comply with this Notice.
'EPA may suspend the registration of each of those products
unless, within the specified time, you have informed 'EPA how
you will satisfy the requirements of this Notice. Any such
suspension will remain in effect until you have complied with
the terms of this Notice.
B. What Generic Data1/ Must be Submitted. You may deter-
mine which generic data you must submit by consulting Table A
at the end of this chapter. That table lists the generic
data needed to evaluate the continued registrabllity of all
products, and the dates by which the data must be submitted.
The required studies must be conducted in accordance with
'EPA approved protocols (such as those contained in the Pesticide
Assessment Guidelines £/ or data collected under the approved
protocols of the Organization for 'Economic Cooperation and
Development (OECD). ,If you wish not to develop data which
are necessary to support the reregistratlon of certain uses
appearing in your labeling, you may delete those uses at the
time you submit your revised labeling.
Also for certain kinds of testing (generally ecological
effects), 'EPA requires the test substance to be a "typical
V Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient (or all such
products having a certain use pattern), regardless of any such
product's unique composition or use. Product-specific data relate
only to the properties or effects of a product with a particular
composition (or a group of products with closely similar composition).
£/ The Pesticide Assessment Guidelines are available in hard
copy or microfiche from the National Technical .Information
Service, 5285 Port Royal Road, Springfield, Va. 22161.
32
-------
formulation," and in those cases 'EPA needs data of that type
for *»ach major formulation category (e.g., emulslflable 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: The "typical formulation" data should
not be confused with product-specific data (Table B) which are
required on each formulation. Product-specific data are
further explained in Chapter .III of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to 'EPA a completed copy of the form entitled "EIFRA
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 following methods you will use to comply with
the requirements of this Notice:
1. (a) Notify 'EPA that you will submit the data, and
(b) either submit the existing data you believe will
satisfy the requirement, or state that you will generate
the data by conducting testing. ,If the test procedures
you will use deviate from (or are not specified in) the
Pesticide Assessment Guidelines or protocols contained in
the Reports of 'Expert Groups to the Chemicals Group,
Organization for 'Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must enclose the
protocols you will use.
OR
2. Notify 'EPA that you have entered into an agreement
with one or more other registrants to Jointly develop (or
share in the cost of developing) the data. ,If you elect
this option, you must notify 'EPA which registrant(s) are
parties to the agreement.
3. File with 'EPA a completed "Certification of Attempt to
'Enter Jnto an Agreement With Other Registrants for Develop-
ment of Data" CEPA Form 8580-6, Appendix ,11-4)«/
OR
V F.IFRA sec. 3(c)(2)(B) authorizes Joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to Jointly develop data but fall to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data Jointly.
(Footnote continued on next page)
33
-------
4. Request that 'EPA amend your registration by deleting
the uses for which the data are needed. (This option is
KOt available to applicants for new products.)
OR
*• 5- Request voluntary cancellation of the registratlon(s)
of your products for which the data are needed. (This option
is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology
and 'Extensions of Time
'EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required data
or how quickly the data must be submitted. .If the test
procedures you plan to use deviate from (or are not specified
in) the registration guidelines or protocols contained in
the reports of the 'Expert Groups to the Chemical Groups,
Organization for 'Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must submit the protocol
for Agency review prior to the Initiation of the test.
.If you think that you will need more time to generate the
required data than is allowed by 'EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product Manager.
The extension request should state the reasons why you conclude
that an extension is appropriate. While 'EPA considers your
request, you must strive to meet the deadline for submitting
the required data.
(Footnote continued from previous page)
In 'EPA's opinion, Joint data development by all registrants
who are subject to the requirements to submit a pertinent item
of data or a cost-sharing agreement among all such registrants
is clearly in the public Interest. Duplication of testing could
Increase costs, tie up testing facilities, and subject an unneces-
sarily large number of animals to testing.
As noted earlier, UFA has discretion not to suspend the
registration of a product when a registrant fails to submit data
required under P.IPRA Section 3(c)(2)(B). 'EPA has concluded that
it is appropriate to exercise its discretion not to suspend in
ways which will discourage duplicative testing. Accordingly, If
(1) a registrant has informed us of his Intent to develop and
submit data required by this Notice; and (2) a second regis-
trant informs 'EPA that it has made a bona fide offer to the
first registrant to share In the expenses of the testing [on
terms to be agreed upon or determined by arbitration under P.IFRA
Section 3(c)(2)(B)(lll)]; and (3) the first registrant has declined
to agree to enter into a cost-sharing agreement, 'EPA will not
suspend the second firm's registration.
34
-------
,111. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: Unless stated otherwise In Section .1, Regulatory
Position and Rationale, this Section applies only to manufac-
turing use products, not to end use products.
A necessary first step in determining which statements
must appear on your product's label is the completion and
submission to 'EPA of product-specific data* listed on the
form entitled "Product Specific Data Report" ('EPA Form
8580-4, Appendix ,11,1-1) to fill "gaps" identified by 'EPA
concerning your product. Under the authority of F.IPRA sec.
3(c)(2)(B), 'EPA has determined that you must submit these
data to 'EPA in order to reregister your product(s). All of
these data must be submitted not later than six months after
you receive this guidance document.
"Product-Specific Data Requirements for Manufacturing
Use Products" appearing in Table B permit you to determine
which product-specific data you must submit. This can be
done by examining the entries in the column of those tables
entitled "Must Data By Submitted Under §3(c)(2)(B)."
V Product specific data pertain to data that support the
formulation which is marketed; it usually Includes product
chemistry data and acute toxicity data.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPACHLOR
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
$158.120 Product Chemistry
Product Identity;
61-1 - Identity of Ingredients TGAI
61-2 - Statement of Composition TGAI
61-3 - Discussion of Formation of TGAI
Ingredients
Analysis and Certification of Product
Ingredients'
62-1 - Preliminary Analysis TGAI
62-2 - Certification of Limits TGAI
62-3 - Analytical Methods for TGAI
Enforcement of Limits
Physical and Chemical Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boiling Point TGAI
63-7 - Density, Bulk Density, or TOAI
^f ic Gravity
Yes
Partially
Yes
No
No
Partially
Yes
Yes
Yes
Yes
Yes
Yes
00104354 No
00104327, 00104354 Yes 2/
00104327, 00104354 No.
00104310, 00104327
00104354
00104327, 00104354
00104327, 00104354
00104327
00104327, 00104354
00104327, 00104354
00104354
Yes 2/
Yes 2/
Yes'2/
No
NO
NO
No
NO
No
36
-------
TABLE A .
GENERIC DATA REQUIREMENTS FOR PROPACHLOR
Data Requirement
!/
Composition
Does EPA Have Data .-Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Sectio
No or Partially) Citation 3(c)(2)(B)?
5158.120 Product Chemistry
63- 8
63- 9
63-10
63-11
63-12
63-13
63-20
(continued)
- Solubility
- Vapor Pressure
- Dissociation constant
- Octanol/water partition
coefficient
- pH
- Stability
- Corrosive Characteristics
TGAI
PAI
PAI
PAI
TGAI
TGAI
TGAI
Yes
Yes
Yes
No
ND
Yes
ND
00104354 No
00104354 No
00104354 No
Yes 4/
Yes 2/
00104354 No
Yes 2/
Other Requirementst
64- 1 - Submittal of samples
Choice
N/A V
37
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPACHLOR
/
$158.120 Product Chemistry
(continued) "~
I/ Composition: TGAI = Technical qrade of the active inqredient: PAI = Pure active ingredient: Choice = Choice of
several test substances determined on a case-by-case basis.
2/ Data must be submitted no later than six months from the receipt date of this guidance package.
3/ N/A= Not required for the purposes of this standard.
4/ Octanol/water partition coefficient data is required by July 1985, because of Agency's concern for possible ground
water contamination by propachlor.
38
-------
TABLS A
GENERIC DATA REQUIREMENTS FOR PROPACPLOR
Data Requirements
Ccnroositiorf
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
under FIFRA Section
3(c)(2)(B)?
S158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- Plants PAIRA
- Livestock
171-4 - Residue Analytical Method
- Plant residues
- Animal residues
PAIRA and plant
metabolites
Partially
Partially
TGAI and metabolites Partially
TGAI and metabolites Partially
00015670, 00092429
00026613, 00092430
00026614, 00093250
00~026614, 00026913
00063712, 00104321
00104311, 00105170
00092430, 00093250
00093251, 00104321
00093252, 00105170
Yes 2/3_/
Yes, 2/4/S/6/
Yes.7/
Yes 7/
171-4 - Storage Stability Data
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
0 Beets, sugar, roots
0 Beets, sugar, tops
0 Corn, forage
0 Corn, grain
PAI
Yes 8/
TEP
TEP
TEP
TEP
Partially
Partially
Partially
Partially
00092429
00092429
00093252, 00104237
00093264
00065896, 00104307
00093517,
Yes 2/9/13/
Yes 2/9A3/
Yes 2/9/10/14/15
Yes 2/9/13/16/
25/
39
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPACHLOR
Data Requirements
Coroosition
Does FPA Have Data
To Satisfy This
I/ Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under PIFRA Section
3(c)(2)(B)?
$158.125 Residue Chemistry
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
0 Corn, sweet
0 Cottonseed
0 Flax, seed
0 Flax, straw
0 Peas
0 Peas, forage
0 Pumpkins
0 Sorghum, grain
0 Sorghum, fodder
0 Sorghum, forage
* Soybeans (for seed)
TEP
Partially
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Partially
Partially
Partially
Partially
Partially
Partially
Partially
Partially
Partially
00065896, 00104307
00093517,
00093518, 00104303
00136439, 00136440
00136439, 00136440
00104312
00104312
00067280
00026612,00105170
00028535
00026612, 00105170
00028535
00026612, 00105170
00028535
TEP
No
Yes 2/9/13/lfi/
T77
Yes 2/1/19/
Yes 2/9/20/
Yes 2/9/
Yes V9/21/
Yes _2/9/21/
Yes 2/9/22/
Yes 2/9/18/
Yes 2/9/
Yes 2/9/
Yes 26/
40
-------
TABLE A
GENERIC DATA REQUIREMENTS PCJR PROPACHLOR
Data Requirement
S158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
- Potable Water
- Fish
- Irrigated Crops
— Field trials
— Processed Food/Feed
- Food Handling
- Meat/milk/poultry/eggs
0 Cattle
0 Milk
0 Goats
0 Hogs
0 Horses
0 Sheep
0 Poultry
0 Eggs
Composition
EP
EP
EP
EP
EP
EP
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TRAI
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
N/A 24/
N/A
N/A
N/A
Reserved
N/A
Partially 00093251, 00093264
No
No
No
No
Partially 00026916
Partially 00026920
Partially 00026920
Must Additional
Data Be Submitted
Under FIFRA Secti<
3(c)(2)(B)?
Yes 2/10/12/
Yes 2/W/I2/
Yes 2/W
Yes 2/W
Yes 2/W
Yes 2/OO/23/
Yes 2/U_/
Yes 2/U/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPACHLOR
§158.125 Residue Chemistry
(continued)
I/ Composition: TGAI » Technical grade of the active ingredient: PAIRA = Pure active ingredient, radiolabelled: TEP =
Typical end-use product; EP = End-use product.
2/ Data must be submitted no later than two years from the receipt date of this guidance package.
3_/ l^c ring labeled data with corn and sorghum up to the seed stage are required.
4_/ l^C ring labeled data on the nature of the residue in ruminants are required.
5/ Data on the metabolism of propachlor in poultry is required.
6/ Data on the metabolism of propachlor in non-ruminants (swine) will be required if rat metabolism data is
is significantly different from the goat or chicken metabolism data.
7/ A radiocarbon study in which samples are analyzed simultaneously by cold and hot analytical methodology for the
N-isopropylaniline moiety including a comparison of the results are required. If other metabolites are found in or
on plants and in animals, then an enforcement method to determine these residues would be required.
8/ Data on the storage stability of propachlor residues in plant and animal samples are required.
9/ Residue data on the metabolites of propachlor in plants are required.
10/ When the residue data gaps have been filled, the registrant should propose a tolerance for residues in or on
corn fodder.
ll/ An additional poultry feeding study on metabolites of propachlor in poultry and eqas will be required if additional
metabolites of concern are found in the poultry metabolism study.
12/ A cow feeding study on propachlor and its metabolites is required. [Previous IRT data invalidated/OGCJ
IV Geographical representation of residue data are not adeouate, therefore, additional field residue data are required.
The registrant should consult the Agency for appropriate geographical areas for residue data.
14/ Residue data on corn forage are required to support the application rate of 6 Ib ai/A on soils with an organic
matter content of more than 3%.
15/ Additional residue data for corn fodder using the 20% granular formulation are required.
If/ Residue data for corn grain using the 20% granular and 42% flowable liouid formulations are required.
IT/ Residue data for sweet corn using the flowable liquid concentrate (FlC) are required.
IB/ Residue data for the oil and milling fractions from the processing of treated corn or sorghum grain are required.
19/ Residue data in cotton forage are required. An acceptable alternative would be a restriction
against the grazing of livestock on cotton forage.
20/ Residue data in flax seed hulls which are fed to livestock are required.
21/ Residue data for peas using the flowable liquid concentrate are required.
22/ Residue data for pumpkins using the 90-day pre harvest or post harvest interval (PHI) are required.
23/ The feeding rate in the sheep study must be clarified.
24/ N/A= Not applicable for the purposes of this standard.
25/ Delete the interpretation as a non-food use, of applications made to hybrid corn grown for seed.
"26 / Delete the interpretation as a non-food use, of applications made to soybeans grown for seed.
42
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPACHLOR
Data Requirement
Composition
Use 2/
Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
S158.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
Photodegradat ion
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LABt
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
TGAI or PAIRA AfB
TGAI or PAIRA A,B
TGAI or PAIRA A
TGAI or PAIRA A
TRAI or PAIRA A,B
TGAI or PAIRA A
TGAI or PAIRA
TGAI or PAIRA
163-1 - Leaching and TGAI or PAIRA A,B
Adsorption/Desorption
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TEP
TEP
NO
NO
NO
N/AV
Partially ll/
Yes
N/A 3/
N/A3/
Partially
N/A V
N/A 3/
00087854
00087854
Yes _4/
Yes y
Yes 6/
Yes 7/
No .
00087854 05016652 Yes 8/12/
43
-------
TABL,. M
GENERIC DATA REQUIREMENTS FOR PRDPACHLOR
Data Requirement
Composition
I/
Use 2/
Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
S158.130 Environmental Fate
(continued)
DISSIPATION STUDIES-PIEID;
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES;
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Target
Organisms
TEP
TEP
TEP
TEP
TEP
PAIRA
TEP
A,B
A
A
TEP
TGAI or PAIRA A,B
TEP
Nb
N/A V
N/A 3/
N/A V
N/A 3/
NO
13/
14/
NO
N/A 3/
Yea 6/
Yes 7/
Yes 3/13/
S Subpart K- Reentry
(1S8.140J
TFP
44
N/A 3/
-------
TABIJ5 A
GENERIC DATA REQUIREMENTS FOR PROPACHLOR
r
C158.130 Environmental Fate
(continued!
I/ Composition: TGAI = Technical grade of the active ingredient: PAIRA = Pure active ingredient, radiolabelled:
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A^Terrestrial, Food Crop; B^Perrestrial, Non-Food: OAquatic, f&od Crop;
D=Aquatic, Non-Food: E=Greenhouse, Food Crop; F=Greenhouse, Non-Food: G=Forestry: H=Domestic Outdoor; I=Indoor.
V N/A= Not applicable for purposes of this standard.
4_/ A hydrolysis/degradation study is required by July, 1985.
5/ A photodegradation study in water is required by July, 1985.
6/ A photodegradation study on soil is required by July, 1985.
7/ An additional metabolism test in aerobic soil is required by July, 1986.
8/ Additional data on mobility of degradates from aged prooachlor are required by April, 1985.
9_/ Soil dissipation data are required by July, 1987.
ID/ Data must be submitted no later than two years from the receipt date of this guidance package.
ll/ Study must be for one year or until patterns of degradate formation and decline are established.
12/ The aged leaching study did not specify aging conditions or soil temperature and moisture content.
Additional data are required on mobility of degradates from aged propachlor.
13/ Data required only if significant residues of concern are detected in the confined accumulation study.
14/ Reclaimed irrigation water not used for crops.
15/ A flow-through test is required.
45
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPACHLOR
Hoes EPA Have Data
To Satisfy This
I/ nse _2/ Requirement? (Yesr Bibliographic
Data Requirement Composition Patterns No or Partially) Citation
.-Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
$158.135 Toxicology
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity
- Acute Inhalation Toxicity
Rat
- Primary Eye Irritation
- Primary Skin Irritation
- Dermal Sensitization
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
ArB
A,B
A,B
A,B
Yes 00104350
Yes 00104351
Nb
Yes 00104352
Yes 00104353
No
N/A 20/
No
No
Yes 3/6/
No 19_/
No.
Yes. 4/7/21/
•
SUBCHRDNIC TESTING:
82-1
82-2
82-3
82-4
82-5
- 90-Day Feeding -
Rodent, Non-rodent
- 21 -Day Dermal
- 90-Day Dermal
- 90-Day Inhalation - Rat
- 90-Day Neurotoxicity -
TGAI
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B .
A,B
ArB
Partially 00093270
N/A 20/
No
No
N/A 20/
Yes 4/W
-
Yes 4/R/
Yes 4/V
_^
Hen/Mammal
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPACHLOR
Data Requirement
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Composition Patterns No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under PIFRA Section
3(c)(2)(B)?
$158.135 Toxicology
(continued)
CHRONIC TESTING;
83-1 - Chronic Toxicity - TGAI A,B
2 species: Rat
Dog
83-2 - Oncogenicity Study - TGAI A,B
2 species: Rat and
Mouse
83-3 - Teratogenicity - TGAI A,B
2 species: Rat and
Rabbit
83-4 - Reproduction, TGAI A,B
2-generation
MUTAGENICITY TESTING
84-2 - Gene Mutation TGAI A,B
84-2 - Chromosomal Aberration TGAI A,B
84-2 - Other Mechanisms of TGAI A,B
Mutagenicity
No
Partially
No
No
No
No
00115136
yes 11/12/
Yes 11/13/
Yes 14/22/
Yes 11/15/
Yes 16/
Yes 16/
Yes 16/
47
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPACHLOR
Data Requirement
Does EPA Have Data
TO Satisfy This
I/ Use 2/ Requirement? (Yes,
Composition Pattern No or Partially)?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIPRA Section
3(c)(2)(B)?
S158.135 Toxicology
(continued)
SPECIAL TESTING
85-1 - General Metabolism PAI or PAIRA ArB
85-2 - Domestic Animal Safety Choice
85-3 - Dermal Absorption Study
Partially
No
N/A 20/
00026913
Yes 4/17/
Yes 5/18/
48
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR AIACHLOR
$158.135 Toxicology
(continued)
I/ Composition: TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; PAIRA » Pure active
ingredient, radiolabelled; Choice = Choice of several test substances determined on a case-by-case basis.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPACHLOR
I/ Use 2/
Data Requirement Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
S158. 145 Wildlife ana
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1
71-2
71-3
71-4
71-5
- Acute Avian Oral Toxicity
- Acute Avian Dietary
Toxicity
a) Upland gamebird
b) Waterfowl
- Wild Mammal Toxicity
- Avian Reproduction
- Simulated and Actual
Field Testing -
Mammals and Birds
TGAI A,B
TGAI A,B
TGAI A,B
TGAI A,B
TGAI A,B
TEP A,B
Yes 00132907
Yes 00132908
Yes 00134006
N/A 7/
N/A 7/
N/A 7/
No
No
No
'
AQUATIC ORGANISM TESTING
72-1
- Acute Freshwater Fish
Toxicity
a) Warmwater
b) Coldwater
c) Warmwater
TGAI A,B
TGAI A,B
TEP A,B
Yes 00104337 3/
GS0177-OOu~l
Yes 00041335
Yes 00041338 3/
GS0177-0001
No.
NO
NO
d) Coldwater
TEP
A,B
Partially
00041337 3/
Yes 4/
50
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPACHLOR
Data Requirement
$158.145 Wildlife and
Aquatic Organisms
(continued)
72-2 - Acute Freshwater
Invertebrate Toxicity
72-3 - Acute Toxicity Estuarine
and Marine Organisms
72-4 - Fish Early Life
Stage and Aquatic
Invertebrate Life-Cycle
72-5 - Fish - Life-Cycle
•
72-6 - Aquatic Organism
V
Composition
TGAI
TEP
TGAI
TGAI
TGAI
TGAI
Use 2/
Pattern
A,B
A,B
A,B
A,B
AfB
A,B
Does EPA Have Data ,Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Sectio
No or Partially) Citation 3(c)(2)(B)?
Yes 00041336 No
GS0177-0001
Yes 00041339 3/ No
GS0177-0001
Reserved 5_/
Reserved 4/
Reserved 4/
Reserved 4/
Accumulation
72-7 - Simulated or Actual
Field Testing -
Aquatic Organisms
TEP
A,B
Reserved 4/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PRQPACHLOR
Data Requirement
!/
Composition
Does EPA Have Data
To Satisfy This
Use 2/ Requirement? (Yes,
Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
$158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORSt
141-1 - Honey bee acute
contact toxicity
141-2 - Honey bee - toxicity
of residues on
foliage
141-4 - Honey bee subacute
feeding study
141-5 - Field testing for
pollinators
TGAI
TEP
A,B
[Reserved] 6/
TEP
Yes
Nb
00028772
No 8/
Nb 8/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPACHDOR
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Pattern No or Partially)
Bibliographic
Citation
'Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
5158.155 Nontarget Insect
(continued)
NONTARGET INSECT
AQUATIC INSECTS;
142-1 - Acute toxicity to
aquatic insects
142-2 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
143-1 - NONTARGET INSECT
TreiTlNG - PREDATC
thru AND PARASITES
143-3
(Reserved)6/
(Reserved)6/
(Reserved)6/
(Reserved)6/
53
-------
TABLE A
C3ENERIC DATA REQUIREMENTS FOR PROPACHIOR
$158.145 Wildlife and Aquatic Organisms
(continued)
I/ Composition: TGAI = Technical grade of the active ingredient; PAI = pure active ingredient:
TEP = Typical end-use product;
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B^Terrestrial, Non-Food Crop; OAquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop: F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ This study must be combined with other studies to fulfill the guideline requirements.
4/ [Reserved] Requirement reserved pending receipt and review of environmental fate data.
5/ [Reserved] Requirement reserved pending receipt and review of environmental fate data (crops grown in coastal
counties on excess of 300,000 acres).
6/ [Reserved] Pending decision as to whether data requirement should be established.
I/ N/A = Not applicable for the purposes of this standard.
8/ No data required because of low acute contact toxicity.
54
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PROPACHLOR
Data Requirement
!/
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
S15R.120 Product Chemistry
Product Identity;
61-1 - Identity of Ingredients TGAI
; 61-2 - Statement of Composition TGAI
61-3 - Discussion of Formation of TGAI
Ingredients
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis TGAI
62-2 - Certification of Limits TGAI
62-3 - Analytical Methods for TGAI
Enforcement of Limits
Physical and Chemical Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boiling Point TGAI
63-7 - Density, Bulk Density, or TGAI
Specific Gravity
Yes
Partially
Yes
No
NO
Partially
Yes
Yes
Yes
Yes
Yes
Yes
00104354 No
00104327, 00104354 Yes 2/
00104327, 00104354 No
00104310, 00104327
00104354
00104327, 00104354
00104327, 00104354
00104327
00104327, 00104354
00104327, 00104354
00104354
Yes 2/
Yes 2/
Yes 2/
No
No
No
No
No
No
55
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANT.FACTURING-USE PRODUCTS CONTAINING PROPACHLOR
!/
Data Requirement Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes
No or Partially)
Must Additional
Data Be Submitted
, Bibliographic Under FTFRA Secti<
Citation 3(c)(2)(B)?
C515R.120 Product Chemistry
63- 8
63- <»
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
(continued)
- Solubility
- Vapor Pressure
- Dissociation constant
- Octanol/water partition
coefficient
- P*
- Stability
- Oxidizinq or Reducing
Action
- Flammability
- Explodabil itv
- Storage Stability
- Viscosity
- Miscibility
- Corrosive Characteristics
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
N/A £/
N/A 4/
N/A 4/
No
No
N/A 4/
No
No
NO
NO
N/A £/
N/A 4/
No
Yes 3/
Yes 2/
-
Yes 2/
Yes 2/
Yes 2/
Yes 2/
-
-
Yes 2/
Other Requirements;
64- 1 - Suhmittal of samples
Choice
N/A 4/
.Sfi
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PROPACHLOR
f
SI58.120 Product Chemistry
(continued)
I/ Composition: MP = Manufacturing-use product; Choice = Choice of several test substances determined on a case-by-
case basis.
2/ Data must be submitted six months from the receipt of this guidance package.
3/ Octanol/water partition coefficient data is required by July 1985, because of Agency's concern for possible ground
water contamination by propachlor.
4/ N/A= Not applicable for the purposes of this standard.
57
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PROPACHLOR
I/
Data Requirement Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
Must Additional
Data Be Submitted
Under FIFRA Sectio
3(c)(2)(B)?
$158.135 Toxicology
ACUTE TESTING
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity
- Acute Inhalation Toxicity
Rat
- Primary Eye Irritation
- Primary Skin Irritation
- Dermal Sensitization
- Acute Delayed
MP
MP
MP
MP
MP
MP
MP
Yes 00104350
Yes 00104351
No
Yes 00104352
Yes 00104353
No
N/A 7/
No
No
Yes 2/4/
No 6_/
No
Yes VV
Neurotoxicity - Hen
-------
TABLE B
38(34) PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PROPACHLOR
r
S158.135 Toxicol
(continued)
I/ Composition: MP » Manufacturing-use product.
2/ Data naist be submitted no later than six months from the receipt of this quidance package.
3/ Data must be submitted no later than one vear from the receipt date of this guidance package.
4/ An acute inhalation toxicity study in the rat is required.
V A dermal sensitization study in the rabbit is required.
6/ Corrosive to the eves, additional data is not necessary.
7/ N/A= Not applicable for the purposes of this standard.
-------
,IV. SUBMISSION OF REVISED LABELING .INFORMATION
Note: This section applies to end use products only to the
extent described in Section .1 (Regulatory Position and
Rationale). Otherwise, the following information pertains
exclusively to manufacturing use products.
P.IPRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the results of data concerning the product and its ingredients.
Labeling requirements are set out in 40 CPR 162.10 (see
Appendix JV-1) and are summarized for products containing
this active ingredient as part of this Guidance Document
(See Appendix JV-2). Applications submitted in response to
this notice must include draft labeling for Agency review.
,If you fail to submit revised labeling information
complying with this section and/or Section .1, 'EPA may issue
a notice of intent to cancel the registration under PJPRA
sec. 6(b)(l).
A. Label Contents
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items
listed below are keyed to Appendix .IV-2.
Jtem 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in ti^e upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Jtem 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
•Item 3. NET CONTENTS - A net contents statement is
require on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." .In addition to 'English units, net contents may
be expressed in metric units. See Appendix JV-1. [40 CPR
I62.10(d)3
Jtem 4. 'EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase '"EPA Registration No.," or '"EPA
Reg. No." The registration number must be set in type of a
60
-------
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix -IV-1.
[40 CPR I62.10(e)]
•Item 5. 'EPA'ESTABLISHMENT NUMBER - The 'EPA establishment
number, preceded by the phrase '"EPA "Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
•It must also appear on the wrapper or outside container of
the package if the 'EPA establishment number on the Immediate
container cannot be clearly read through such wrapper or container
See Appendix JV-1. [40 CPR l62.10(f)D
•Item 6. .INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel and must contain the name and
percentage by weight of each active ingredient and the total
percentage by weight of all inert ingredients. The preferred
location is immediately below the product name. The ingredients
statement must run parallel with, and be clearly distinguished
from, other text on the panel. .It must not be placed In the
body of other text. See Appendix ,IV-1. [40 CPR l62.10(g)]
Jtem 6A. 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 as Re- "Keep Out of Reach
on Front Panel quired Minimum Type of Children"
in Square .Inches Size All Capitals as Required
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
.Item 7A. CHILD HAZARD WARMING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. See Appendix .IV-1.
[40 CFR I62.10(h)(l)(il)]
.Item 7B. SIGNAL WORD - The signal word (Caution, Warning,
or Danger) is required on the front panel immediately below
the child hazard warning statement. See Appendix .IV-1.
[40 CPR 162.10 (h)(l)(i)]
a.
-------
•Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxiclty Category ,1 on the basis of oral, dermal,
or Inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the ckull and crossbones shall appear in immediate proximity to
•the word POISON. See Appendix JV-1. [10 CPR 162. 10 (h) (1) (1) ]
Jtem 7D. STATEMENT OP PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories .1,
.II, and ,111. See Appendix JV-1. [10 CPR I62.10(h)(l) (ill)]
Jtem TE. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
See Appendix JV-1. [10 CFR 162 .10(h) (l)
Jtem 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. 'Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix JV-1. [10 CPR 162.10
Jtem 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
routc-(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. See Appendix JV-1. [10 CFR 162.10
Jtem 8B. 'ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and. the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix JV-1. [10 CPR
Jtem 8C. PHYSICAL OR CHEMJCAL 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 JV-3. The require-
ment is based on the results of the flashpoint determinations
and flame extension tests required to be submitted for all
products. These statements are to be located in the side/back
panel precautionary statements section, preceded by the
heading "Physical/Chemical Hazards." Note that no signal
word is used in conjunction with the flammability statements.
62
-------
2. Criteria for declaration of non-flammability. The
following criteria will be used to determine if a product
is non-flammable:
a. A "non-flammable gas" is a gas (or mixture of gases)
that will not ignite when a lighted match is placed
against the open cylinder valve.
b. A "non-flammable liquid" is one having a flashpoint
greater than 350°P (177°C).
c. A "non-flammable aerosol" is one which meets the
following criteria:
1. The flame extension Is zero Inches;
11. There Is no flashback; and
ill. The flashpoint of the non-volatile liquid
component is greater than 350°P (177°C).
3. Declaration of non-flammablllty. Products which
meet the criteria for non-flammabillty specified
above may bear the notation "non-flammable" or "non-
flammable (gas, liquid, etc.)" on the label. Jt 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.
1*. Other physical/chemical hazard statements. When
chemistry data demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such statements
may address hazards of explosivity, oxidizing or reducing
capability, or mixing with other substances to produce
toxic fumes.
.Item 9. PRODUCT CLASSIFICATION - Section 3(d) of F.IFRA
requires that all pesticide formulations/uses be classified
for either general or restricted use, and that those uses
classified as restricted be limited to use by certified
applicators or persons under their direct supervision (or
subject to other restrictions that may be Imposed by regulation).
•In the Registration Standard, the Agency has (1) indicated
certain formulations/uses to be restricted, based either on a
previous classification determination made through the optional
procedures of 40 CPR 162.30 or based on data already available
to the Agency, or (2) reserved any classification decision until
appropriate data are submitted.
63
-------
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. .If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
X.
•If you wish to propose that your product should not be
classified for restricted use, you must submit any information
and rationale with your application for reregistration.
During the Agency's review of your application, your proposed
classification determination will be evaluated in accordance with
the provisions of HO CPR I62.11(c). You will be notified of
the Agency's classification decision.
A. Classification Labeling Requirements
1. All Uses Restricted - Pesticide products bearing
directions for use for formulations or uses classified
restricted shall bear statements of restricted use classi-
fication on the front panel as described below:
a. The statement "RESTRICTED USE PESTICIDE,"
must appear at the top of the front panel of the
label, set in type of the same minimum sizes as
required for human hazard signal words (see table in
40 CFR I62.10(h)(l)(iv).
b. Directly below this statement on the front
panel, a summary statement of the terms of restric-
tion shall appear. .If use is restricted to certified
applicators, the following statement is required:
"For retail sale to and use only by Certified Applicators
or persons under their direct supervision and only
for those uses covered by the Certified Applicator's
Certification."
2. Some But Not all Uses Restricted - .If the Regula-
tory Position and Rationale states that some uses are
classified for restricted use and some uses are unclassified,
several courses of action are available:
a. You may label the product for restricted use.
.If you do so, you may Include those uses that are
unrestricted, but you may not distinguish them on
the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unres-
tricted uses.
64
-------
c. You may "split" your registration, I.e.,
register two separate products with identical formula-
tions, one containing only unrestricted uses, and
the other restricted uses. To do so, submit two
applications for reregistration, each containing all
forms and necessary labels. Both applications should
be submitted simultaneously. Note that the product
names will be assigned separate registration numbers.
B. Compliance Schedules
No product with a use classified for restricted use
under this Standard may be released for shipment by the
registrant or producer after one year from the date of
Issuance of this Standard, unless such product bears the
restricted use classification. All products still in
channels of trade after two years from the date of issuance
of this Standard must be labeled for restricted use.
-Item IDA. STORAffE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix
JV-4 to determine the disposal instructions appropriate for
your products.
•Item 10B. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use. or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix -IV-1. [HO CPR 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 labeling. Such labeling may not bear claims or
representations that differ in substance from those accepted
In connection with registration of the product. .It should be
made part of the response to this notice and submitted for
review.
65
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V. .INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
Robert Taylor
Product Manager
^ registration Division (TS-767C)
Office of Pesticide Programs
'Environmental Protection Agency
Washington, D.C. 20-460
Phone No. (703) 557-1800
For each product for which continued registration is desired:
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 labeling must comply specif-
ically with the instructions in Section ,11 (Regulatory
Position and Rationale) of this guidance document.
The labeling should be either typewritten text on 8-1/2
x 11 inch paper or a mockup of the labeling suitable
for storage in 8-1/2 x 11 Inch files. The draft label
must Indicate the intended colors of the final label,
clear indication of the front panel label, and the intended
type sizes of the text.
e. 'Evidence of compliance with data support requirements
of FJFRA sec. 3(c)(l)(D). Refer to PR Notice 84-1 (enclosed)
for latest requirements.
3. 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 meeting the agreed submission time will be
delayed, notify the Product Manager.
66
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Appendix II-l
Guide to Use of This Bibliography
Content of Bibliography; This bibliography contains citations of all the
•studies reviewed by EPA in arriving at the positions and conclusions stated
elsewhere in the Standard. The bibliography is divided into two sections:
(1) citations that contributed information useful to the review of the chemical
and that are considered to be part of the data base supporting registrations
under the Standard, and (2) citations examined and judged to be inappropriate
for use in developing the Standard. This second part of the bibliography
exists in the Agency's files and does not accompany this Standard. Interested
parties may request a copy from the Agency. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its
predecessor agencies in support of past regulatory decisions, and the published
technical literature.
Units of Entry; The unit of entry in this bibliography is called a "study".
In the case of published materials, this corresponds closely to an article.
In the case of unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to the published
article from within the typically larger volumes in which they were submitted.
The resulting "studies" generally have a distinct title (or at least a single
subject), can stand alone for purposes of review, and can be described with a
conventional bibliographic citation. The Agency has attempted also to unite
basic documents and commentaries upon them, treating them as a single study.
Identification of Entries; The entries in this biblicqraphy are sorted by
author, date of the document, and title. Each entry bears, to the left of the
citation proper, an eight-digit numeric identifier. This number is unique to
the citations, and should be used at any time specific reference is required.
This number is called the "Master Record Identifier", or "MRID". It is not
related to the six-digit "Accession Number" which has been used to identify
volumes of submitted data: see paragraph 4(d)(4) below for a further
explanation. In a few cases, entries added to the bibliography late in the
review may be preceded by an eight-character temporary identifier. This is
also to be used whenever specific reference is needed.
Form of the Entry; In addition to the Master Record Identifier (MRID),
each entry consists of a bibliographic citation containing standard elements
followed, in the case of materials submitted to EPA, by a description of the
earliest known submission. The bibliographic conventions used reflect the
standards of the American National Standards Institute (ANSI), expanded to
provide for certain special needs. Some explanatory notes of specific
elements follow;
a. Author: Whenever the Agency could confidently identify one, the
Agency has chosen to show a personal author. When no individual was
identified, the Agency has shown an identifiable laboratory or
testing facility as author. As a last resort, the Agency had shown
the first known submitter as author.
-67-
-------
b. Docunent Date: When the date appears as four digits with no question
marks, the Agency took it directly from the document. When a four
digit date is followed by a question mark, the bibliographer deduced
the date from evidence in the document. When the date appears as
(19??), the Agency was unable to determine or estimate the date of
the document.
c. Title: This is the third element in the citation. In some cases it
has been necessary for Agency bibliographers to create or enhance a
document title. Any such editorial insertions are contained between
square brackets.
d. Trailing Parentheses: For studies submitted to the Agency in the
past, the trailinq parentheses include (in addition to any self-
explanatory text) the following elements describing the earliest
known submission:
(1) Submission Date: immediately following the word 'received'
appears the date of the earliest known submission.
(2) Administrative Number: The next element, immediately following
the word 'under', is the registration number, experimental
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 by1. When authorship is defaulted to the
submitter, this element is omitted.
(4) Volume Identification: The final element in the trailing
parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six
digit accession number follows the symbol 'CDL1, standing for
"Company Data Library". This accession number is in turn
followed by an alphabetic suffix which shows the relative
position of the study within the volume. For example, within
accession number 123456, the first study would be 123456-A: the
second 123456-B; the 26th, 123456-Z; and the 27th 123456-AA.
-68-
-------
Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propachlor Standard
00015670 Lamoureux, G.L.; Stafford, L.E.; Tanaka, F.S. (1971) Metabolism of
2-Chloro-N-isopropylacetanilide (Propachlor) in the leaves
of corn, sorghum, sugarcane, and barley. Journal of Agricul-
tural and Food Chemistry 19(2):346-350. (Also in unpublished
submission received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.: CDL:094221-D)
00026612 Shuman, A.C. (1966) Recovery Studies in Sorghum. (Unpublished
study received on unknown date under 6F0479: submitted by Mon-
santo Co., Washington, D.C.; CDL:090535-F)
00026613 Monsanto Company (19??) Summary of Metabolism of CP 31393-H3 in
Sorghum. (Unpublished study received Auq 12, 1965 under 6F0479:
CDL:090535-G)
00026614 Monsanto Company (19??) Summary of Residue, Metabolism and Toxico-
logical Studies with CP 31393. (Unpublished study received Aug
12, 1965 under 6F0479; CDL:090535-H)
00026913 Monsanto Company (19??) Excretion Studies of CP 31393-H3 and CP
31393-H3 Corn Metabolite in Rats and Goats. (Unpublished
study received Jul 20, 1965 under 524-152; CDL:003990-C)
00026916 Monsanto Company (1964) Results of Silage Feeding Studies in Sheep.
(Unpublished study received Jul 20, 1965 under 524-152; CDL:
003990-F)
00026920 Monsanto Company (19??) Results of Soybean Meal Feeding Studies on
Laying Hens. (Unpublished study received Jul 20, 1965 under
524-152; CDL:003990-J)
00028535 Lauer, R.: Adams, S.: Arras, D.: et al. (1980) Residues of Propa-
chlor and Atrazine in Field Treated Sorghum following Preemer-
gent Application with Ramrod (R) Atrazine Tank Mix: Report
No. MSL-1088. Final rept. (Unpublished study received May 6,
1980 under 524-328; prepared in cooperation with Biospherics,
Inc., submitted by Monsanto Co., Washington, D.C.; CDL:099429-A)
00028772 Atkins, E.L.; Greywood, E.A.: Macdonald, R.L. (1973) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. Rev. By Univ. of California—Riverside, Dept.
of Entomology. Riverside, Calif.: UC, Agricultural Extension
Service. (Also in unpublished submission received Apr 2, 1980
under 464-556; submitted by Dow Chemical U.S.A., Midland, Mich.;
CDL:242149-Z)
-69-
-------
00041335 Thompson, C.M.; Forbis, A.D.: Oleson, P.B.: et al. (1980) Acute
Toxicity of Propachlor (AB-79-080) to Rainbow Trout (Salmo
gairdneri): Static Acute Bioassay Report * 24019. (Unpub-
lished study including letter dated Nov 13, 1979 from F.B. Ole-
son to W.D. Carpenter, received Sep 19, 1980 under 524-310: pre-
pared in cooperation with Analytical Bio Chemistry Laboratories,
Inc., submitted by Monsanto Co., Washington, D.C.t CDL:099654-B)
00041336 Thompson, C.M.: Forbis, A.D.; Fuhremann, T.W. (1980) Acute Toxicity
of Prooachlor (AB-79-250) to Daphnia magna: Static Acute Bio-
assay Report 24708. (Unpublished study including letter dated
Jan 8, 1980 from T.W. Fuhremann to W.D. Carpenter, received
Sep 19, 19RO under 524-310; prepared in cooperation with Ana-
lytical Bio Chemistry Laboratories, Inc., submitted by Monsanto
Co., Washington, D.C.: CDL:099654-C)
00041337 Thompson, C.M.; Forbis, A.D.? Oleson, F.B.; et al. (1980) Acute
Toxicity of Ramrod (R) Flowable (AB-79-084) to Rainbow Trout
(Salmo gairdneri): Static Acute Bioassay Report t 24023.
(Unpublished study including letter dated Nov 13, 1979 from F.B.
Oleson to W.D. Carpenter, received Sep 19, 1980 under 524-310;
prepared in cooperation with Analytical Bio Chemistry Labora-
tories, Inc., submitted by Monsanto Co., Washington, D.C.; CDL:
099654-D)
00041338 Thompson, C.M.; Forbis, A.D.; Oleson, F.B.; et al. (1980) Acute
Toxicity of Ramrod (R) Flowable (AB-79-085) to Bluegill Sunfish
(Lepcmis macrochirus): Static Acute Bioassay Report # 24024.
(Unpublished study including letter dated Nov 12, 1979 from
F.B. Oleson to W.D. Carpenter, received Sep 19, 1980 under 524-
310; prepared in cooperation with Analytical Bio Chemistry Labo-
ratories, Inc., submitted by Monsanto Co., Washington, D.C.:
CDL:099654-E)
00041339 Thompson, C.M.; Forbis, A.D.r Oleson, F.B. (1980) Acute Toxicitv
of Ramrod (R) Flowable (AB-79-086) to Daphnia magna: Static
Acute Bioassay Report i 24025. (Unpublished study including
letter dated Nov 7, 1979 from F.B. Oleson to W.D. Carpenter,
received Sep 19, 1980 under 524-310; prepared in cooperation
with Analytical Bio Chemistry Laboratories, Inc., submitted by
Monsanto Co., Washington, D.C.; CDL:099654-F)
00063712 Monsanto Company (1979) Propachlor: Residue Tolerance Petition—
Dry Bulb Onions. (Compilation: unpublished study received Nov
' 20, 1980 under 524-152; CDL:099752-A)
-70-
-------
00065896 Monsanto Company (1967) Summary of Residue Determinations for
2-Chloro-N-isopropylacetanilide in or on Mature Corn Grain.
Includes undated methods entitled: The determination of residues
of 2-chloro-N-isopropylacetanilide in corn by column and gas-
liquid chromatography; "Hie determination of residues of 2-
chloro-N-isopropylacetanilide and metabolites containing the
N-isopropylanilinine moiety. (Unpublished study received Apr
2, 1968 under 8F0672: CDL:091181-D)
00067280 Reimann, L. (1980) Minor Use Residue Report Form: Propachlor:
Pumpkin. (Unpublished study received Aug 21, 1980 under
9E2140; prepared in cooperation with Michigan State Univ. and
United States Testing Co., Inc., submitted by Interregional Re-
search Project No. 4, New Brunswick, N.J.; CDL:099562-A)
00087854 Brightwell, B.B.: Malik, J.M.; Wong, S.C. (1981) The Environmental
Fate of Propachlor ... in Soil and Water: Report No. MSL-1900.
Final rept. (Unpublished study received Dec 23, 1981 under
524-310; submitted by Monsanto Co., Washington, D.C.; CDL:
246507-A)
00092429 Monsanto Company (19??) Results of Tests on the Amount of Residue
Remaining Including a Description of the Analytical Method Used:
Metabolism of CP 31393-H3 in Sugar Beets. (Unpublished
study received Nov 27, 1966 under 7F0553: CDL:090686-C)
00092430 Monsanto Company (19??) Results of Test on the Amount of Residue
Remaining Including a Description of the Analytical Method Used:
Metabolism of CP 31393-H3 in Corn. (Unpublished study re-
ceived Nov 27, 1966 under 7F0553; QDL:090686-D)
00093250 Monsanto Company (19??) Results of Test on the Amount of Residue
Remaining Including a Description of the Analytical Method Used:
Ramrod. (Unpublished study received Nov 17, 1964 under
6F0479; CDL:090536-B)
00093251 Monsanto Company (1965) Results of Tests on the Amount of Residues
Remaining Including a Description of the Analytical Method Used:
Ramrod. (Unpublished study received on unknown date under
6F0479; CDL:090536-C)
00093252 Monsanto Company (1965) Results of Tests on the Amount of Residue
Remaining Including a Description of the Analytical Method Used:
Ramrod. (Unpublished study received on unknown date under
6F0479; CDL:090536-E)
00093264 Monsanto Company (1966) Results of Tests on the Amount of Residue
Remaining Including a Description of the Analytical Method Used:
Ramrod. (Compilation: unpublished study received on unknown
date under 6F0479; CDL:090537-A)
-71-
-------
00093270 Wazeter, F.X.: Buller, R.H.: Geil, R.G. (1964) Ninety-day Feeding
Study in the Rat; Ninety-day Feeding Study in the Dog: 138-001
and 138-002. (Unpublished study received Jul 10, 1964 under
6F0479; prepared by International Research and Development
Corp., submitted by Monsanto Co., Washington, D.C.; CDL:
090537-G)
00093517 Monsanto Company (1965) Results of Tests on the Amount of Residue
Remaining Including a Description of the Analytical Method Used:
N-Isopropylaniline. (Incomplete: unpublished study received
Jan 3, 1966 under 7F0524; ODL:090625-M)
00093518 Monsanto Company (1965) Results of Tests on the Amount of Residue
Remaining Including a Description of the Analytical Method Used:
CP 31393. (Compilation; unpublished study received Jan 3,
1966 under 7F0524; CDL:090625-0)
00104237 Monsanto Company (19??) Results of Test on the Amount of Residue
Remainina Including a Description of the Analytical Method Used:
CP 31393. (Unpublished study received Jan 3, 1966 under
7F0524; CDL:090625-N)
00104303 Monsanto Co. (1965) CP-31393-H3: Residues in Cottonseed. (Com-
pilation: unpublished study received Jan 27, 1966 under 524-
152; CDL:004002-A)
00104307 Monsanto Co. (1964) Ramrod: Residues in Soybeans. (Compilation:
unpublished study received Dec 14, 1965 under 524-152; CDL:
017108-A)
00104310 Monsanto Co. (19??) Analysis of Ramrod via Gas Chromatography.
(Unpublished study received Aug 15, 1974 under 524-310; CDL:
026629-A)
00104311 Monsanto Co. (1966) The Results of Tests on the Amount of Residue
Remaining Including a Description of the Analytical Methods
Used: Ramrod. (Unpublished study received Cct 5, 1967 under
8F0642; CDL:091113-A)
00104312 Monsanto Co. (1967) Results of Tests on the Amount of Residue
Remaining Including a Description of the Analytical Methods
Used: Ramrod. (Unpublished study received Cct 25, 1969 under
9F0854; CDL:091476-A)
00104321 Monsanto Co. (1967) Ramrod: Residues in Corn and Cotton. (Com-
pilation: unpublished study received on unknown date under
7F0524: CDL:098603-A)
-72-
-------
00104327 Dow Chemical U.S.A. (1976) Chemical Studies of Propachlor. (Com-
pilation; unpublished study received Aug 30, 1977 under 464-548:
O>L:231870-B)
•00104337 Morrill, L. (1973) Acute Toxicity of Ramrod to Bluegill (Lepomis
macrochirus). (Unpublished study received Jul 3, 1979 under
524-331: prepared by Bionomics, Inc., submitted by Monsanto
Co., Washington, DC; CDL:238764-F)
00104350 Heenehan, P.; Rinehart, W.; Braun, W. (1979) Acute Oral Toxicity
Study in Rats: Project No. 4887-77: BDN-77-430. Rev. (Unpub-
lished study received Oct 16, 1979 under 524-152: prepared by
Bio/dynamics, Inc., submitted by Monsanto Co., Washington, DC:
CDL:241292-J)
00104351 Braun, W.: Rinehart, W. (1978) Acute Dermal Toxicity Study in
Rabbits: Pro-iect No. 4888-77; BDN-77-430. (Unpublished study
received Oct 16, 1979 under 524-152: prepared by Bio/dynamics,
Inc., submitted by Monsanto Co., Washington, DC; CDL:241292-K)
00104352 Heenehan, P.: Braun, W.: Rinehart, W. (1979) Rabbit Eye Irritation
Study: Project No. 4889-77; BDN-77-430. Rev. (Unpublished
study received Oct 16, 1979 under 524-152: prepared by Bio/dy-
namics, Inc., submitted by Monsanto Co., Washington, DC; CDL:
241292-L)
00104353 Heenehan, P.: Braun, W.; Rinehart, W. (1979) Primary Dermal Irri-
tation Study in Rabbits: Project No. 4890-77; BDN-77-430. Rev.
(Unpublished study received Oct 16, 1979 under 524-152; prepared
by Bio/dynamics, Inc., submitted by Monsanto Co., Washington,
DC; CDL:241292-M)
00104354 Monsanto Co. (1979) Chemistry of Propachlor. (Compilation; un-
published study received Jul 3, 1979 under 524-331; CDL:
238763-A)
00105170 Adams, S.; Dubelman, S. (1982) Residues of Propachlor, Propazine,
and Atrazine in Field Treated Sorghum Following Preemergent Ap-
pilication with Ramrod/Milogard or Postemergent Application with
Ramrod/Atrazine Tank Mixes: MSL 2244. (Unpublished study re-
ceived Jun 21, 1982 under 524-328; submitted by Monsanto Co.,
Washington, DC: CDL:247704-A)
00115136 Schardein, J.: Wahlberg, D.: Allen, S.: et al. (1982) Teratology
Study in Rats (IR-8i-264): 401-171. (Unpublished study received
Aug 21, 1972 under 524-152; prepared by International Research
and Developnient Corp., submitted by Monsanto Co., Washington,
DC; CDL:248368-A)
-73-
-------
00132907 Fink, R.; Beavers, J.; Brown, R.; et al. (1979) Acute Oral LD50:
Bobwhite Quail: Propachlor: Project No. 139-172. Final
rept. (Unpublished study received Dec 2, 1983 under 524-152;
prepared by Wildlife International Ltd., submitted by Monsanto
Co., Washington, DC; CDL:251864-A)
0013290R Beavers, J.; Jaber, M.: Joiner, G.; et al. (1983) An Eight-day
Dietary LC50 in Bobwhite Quail with Prooachlor: Project No. 139-
217. Final rept. (Unpublished study received Dec 2, 1983 under
524-152: prepared by Wildlife International Ltd., submitted by
Monsanto Co., Washington, DC: CDL:251864-B)
00134006 Beavers, J.; Jaber, M.; Joiner, G.; et al. (1983) An Eight-day
Dietary LC50 in Mallard Ducks with Propachlor: Project No. 139-
216. Final rept. (Unpublished study received Dec 2, 1983 under
524-152; prepared by Wildlife International Ltd., submitted by
Monsanto Co., Washington, DC: CDL:251864-C)
00136439 Interregional Research Project No. 4 (1979) The Results of Tests on
the Amount of Propachlor Residues Remaining in or on Flax Seed
and Straw Including a Description of the Analytical Method Used.
(Compilation: unpublished study received Oct 4, 1979 under
OE2278; CDL:099032-A)
00136440 Interregional Research Project No. 4 (1979) Efficacy of Propachlor
Herbicide. (Compilation; unpublished study received Cct 4,
1979 under OE2278; CDL:099032-B)
05016652 Helling, C.S. (1971) Pesticide Mobility in Soils: II. Applications
of Soil Thin-Layer Chromatography. Proceedings of the Soil
Science of America 35(5):737-748.
-74-
-------
GS0177-001 Johnson, W.W.: Finley, M.T. (1980) Handbook of Acute Toxicity
of Chemicals to Fish and Aquatic Invertebrates. USDI Fish and
Service, Resource Publication 137. June 1983 update.
-75-
-------
Appendix IV-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA *F" List)
Active Ingredients;
Isobutyl alcohol
Lead acetate
Lindane
Maleic^hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
elenium disulfide
^ilvex
1,2,4,5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Freon 11*)
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
100
-------
Appendix II-3
OMB Approval No. 2000-0468
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
RODUCTNAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
D1. I will submit data in a timely manner to satisfy the following requirement! If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
D 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
D 3. I inclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
D 5. I request voluntary cancellation of the registration of this product (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8580-1 (1042)
76
-------
Appendix 11-4
OMB Approval No. 2000-0468
(To qualify, certify ALL four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is wilting to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly., or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included an offer to In-
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was madt
to the following firm(s) on the following dated):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly in
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This staU
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 86OW (10-82)
77
-------
Appendix .111-1
'EPA Registration No.
PRODUCT SPECIFIC DATA REPORT
Guidance Document for_
- Date
k.
Registration
Guideline No.
§158.20
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
-Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor jpressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Test not
required
for my
product
listed
above
(check
below)
.1 am complying with
data requirements by
Citing MRID#
Submit-
ting
Data
(At-
tached)
(For 'EPA Use Only)
Accession Numbers
Assigned
78
-------
Appendix .111-1 (continued)
X.
Registration
Guideline No.
6?-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of lest
Stability
Oxidizing/ reducing
reaction
Plainnability
'Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral ID-50,
rat
Acute dermal
ID-50
Acute inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensltiza-
tion
Test not
required
for my
product
listed
above
(check
below)
.1 am complying with
data requirements by
Citing MRID#
Submit-
ting
Data
(At-
tached)
(For 'EPA Use Only)
Accession Numbers
Assigned
79
-------
Appendix IV-1
Chapter I—Environmental Prettction Agtncy
§ 162./0
at obtained the data from anoth<
firn (identify): applicant copied da.
Iron a publication: applicant obtained
a coty of the data from EPA).
(dVThe applicant shall submit
his application a statement that
in its ^valuation of the properties/effi
cacy. Ynd safety of the formulated
end-usa product, may not consid/r any
data a& supporting the application.
except tse following data:
(1) Thl data the applicant /as sub-
mitted to\EFA under paragraph (b) of
thissectk
(2) Oth&r data pertaining to the
safety of tie product's actve ingredi-
ents. rather\than to the safety of the
end-use pi
Uhan to the
jet; and
(3) Existing tolerances,
regulations, exemptions]
clearances issied undei
Food, Drug, ann Cosmet
>od additive
and other
the Federal
Act.
lows that any
tted under this
by (or at the ex-
an who original-
to EPA (or its
(e) If the applicant
item of data heXsubi
section was generated
pense of) another\pe
ly submitted the
predecessor, USDA)/on or after Janu
ary 1, 1970. to supfort an application
for registration.
permit, or amen
use to an exlstin
reregistration (
xperimental • use
nt adding a new
' istration, or for
the applicant
and the origlna/ data\ submitter have
reached writte* agreement on the
amount and the tennsW payment of
any compensa/ion thal\ may be pay-
able unde/ FIFRA section
3(c)UXD)(H)/vith regard to approval
of the application), the applicant shall
submit to KPA a statement that he
has furnishjed to each sucfe identified
original da/a submitter:
(DA notification of the ipplicant's
intent to Ipply for registraticp. includ-
ing the proposed product i
(2) An/offer to pay the perfen com-
pensatif n. with regard to the approval
of the/application, to the extent re-
quiredf by FIFRA sections 3(c\QXD)
and 3fc)(2XD);
(3)/An Identification of the itm(s)
la to which the offer applies*
An offer to commence negktia-
to ascertain the amount Vnd
of compensation to be paid:
fS) The applicant's name, add
id telephone number.
If the applicant's product ton-
tain any active ingredient other /han
thos\ that are present solely because
of thekincorporation into the psoduct.
duringXformulation, of one o/ more
other Kgistered pesticide Products
purchase from another /roducer.
then the\applicant shall a Wo comply
with i 162JB-5 as to such a/tive ingre-
dient, and Yhe applicatio/ shall con-
tain an acfargwledgment/hat for pur-
poses of FIFRA sectionyS(c)(l)(D) the
application relies on (and any result-
Ing reglstrationXshould' be regarded as
Administrator's
following data:
Ited or specifically
int in support of
of data in the
if it were based
consideration of
(1) All data sub
cited by the appl
the registration:
(2) Each othe/ite
Agency's files w/ic.h:
(i) Concerns /le properties or effects
of any such raive ingreqient; and
(11) Is one /f the typeApf data that
EPA would /equire to be sVbmitted for
scientific uview by EPA i\ the appli-
cant sou/u the initial registration
under 9FRA Section 3(c\5) of a
product/with composition anoL intend-
ed usearidentical to those proposed for
the applicant's product, undir the
data/requirements in effect o\ the
dater EPA approves the applicant's
present application.
(wcs. 3, 6, and 29 of FIFRA. as amended
7£.C. 136 «/*««.>
(44 FR 27953. May 11. 1979]
1 162.10 Labeling requirement*.
(a) General— (I) Contents of the
label Every pesticide products shall
bear a label 'containing the informa-
tion specified by the Act and the regu-
lations in this Part. The contents of a
label must show, clearly and promi-
nently the following:
(1) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this
section:
(11) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section;
(ill) The net contents as prescribed
In paragraph (d) of this section:
80
-------
§ 162.10
Tltlt 40—Protection of Environmen
(iv) The product registration
number as prescribed in paragraph (e)
of this section;
(v) The producing establishment
number as prescribed in paragraph (f)'
of this section;
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this
section:
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(viii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix) The use classification(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
ary conditions of purchase and use.
(ii) All required label text must:
(A) Be set in 6-point or larger .type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary,
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—M General
The label shall appear on or be secure-'
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act. "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container throug)
which the label cannot be clearly read
the label must also be securely at
tached to such outside wrapper or cor.
tainer, if it is a part of the package a
customarily distributed or sold.
(ii) Tan* cars and other bulk cor.
Joiners—(A) Transportation. While
pesticide product is in transit, the ap
proprlate provisions of 49 CFR Part
170-189. concerning the transponatio.
of hazardous materials, and specifica
ly those provisions concerning the \i
beling. marking and placarding of ha:
ardous materials and the vehicles ca:
rying them, define the basic Feder;
requirements. In addition, when an
registered pesticide product is tran;
ported in a tank car, tank truck c
other mobile or portable bulk contaii
er, a copy of the accepted- label mui
be attached to the shipping paper
and left with the consignee at the tiro
of delivery.
(B) Storage. When pesticide prot
ucts are stored in bulk container
whether mobile or stationary,_whic
remain in the custody of
copy of the label of labeling.
all appropriate directions for
be securely attached to the contain*
in the ImmedlaTe vicinity of the di
charge control valve.
(5) False or misleading statement
Pursuant to section 2
-------
Chopttr I—Environmental Protection Agtncy
§162.10
any agency of the Federal Govern-
ment;
(vi) The name of a pesticide which
contains two or more principal active
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling:
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its ingredients, Including
statements such as "safe," "nonpoison-
ous," "noninjurious." "harmless" or
"nontoxic to humans and pets" with
or without su
-------
§ 162.10
TltU 40-—Protection of Environment
allel to it. The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or Imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.". of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—(I) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert ingredients." or the singu-
lar forms of these terms when appro-
priate. Both terms shall be In the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the Ingredient statement.
(2) Position of ingredient statement.
(I) The ingredient statement is nor-
mally required on the front panel of
the label. If there is an outside con-
tainer or wrapper through which the
ingredient statement cannot be clearly
read, the ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes it Impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
(ii) The text of the ingredient state-
ment must run parallel with other
text on the panel on which it appears.
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement. The name used for each in-
gredient shall be the accepted
common name, if there is one. fol-
lowed by the chemical name. The
common name may be used alone only
If it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25(c)(6)..
(4) Statements of percentages. The
percentages of ingredients shall be
stated In terms'of weight-to-weight.
The sum of percentages of the active
and the inert Ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25^" If
the uses of the pesticide proc
expressed as weight of active
ent per unit area, a statement^
weight of active ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may tx
present.
(6) Deterioration. Pesticides which
change in chemical composition sig
nificantly must meet the following la
beling requirements:
(1) In cases where it is determlnec
that a pesticide formulation change:
chemical composition significantly
the product must bear the followini
statement in a prominent position 01
the label: "Not for sale or use afte
[date]."
(U) The product must meet all labe
claims up to the expiration time ind:
cated on the label.
(7) Inert ingredients. The Adminii
trator may require the name of an
83
-------
Chapttr I—Environmental Protection Agency
§162.10
inert ingredient! s) to b« listed in the
ingredient statement if he determines
that such ingredient(s) may pose a
hazard to man or the environment.
(h) Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of toxicological
hazard including hazard to children.
environmental hazard, and physical or
chemical hazard fall Into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement,
type size, and prominence are given
below.
(1) Required, front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
Tojocrty catagorm
Hazard mdcaten |
1-
II
!
rv
Oral 1.0. Up lo ane odudng SO | From SO Wu 400 mg/kg j From 500 mm 5000 mg/ , Graatar mar 5000 mg/
I mg/kg ; kg j kg
..{ Up to and «
-------
§ 162.10
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
-------
Chapter I—Environmental Protection Agency
§ 162.10
stances under which they are required
follow:
(A) If a pesticide Intended for out-
door use contains an active ingredient
with a mammalian acute oral LD» of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LCM of 1 ppm or less.
the statement "This Pesticide is Toxic
to Fish" is required.
(C) If a pesticide intended for out-
door use contains an active Ingredient
with an avian acute oral LDM of 100
mg/kg or less, or a subacute dietary
LCM of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result In fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses Involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes.
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(ili) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Raqurad tan
(A) PKMsunato COMTAMCM
Flaah POM *i or baov 20" f.t nara • a tombac* at Extramaly nammaola Conianu iro* prauur* K»rp »-»y from
any v*v« opanmg. , *ra. aparta. and haatae aurtaen. Do net punctur* o> ron«r«l«
• contanar ioown 10 «amparatura» abova IX' f may caua*
1 bmtng.
Fleaft port abova 20* F md no) owr W f or I (h« | Flammawa Contanti undar prattm. Ka*p avay trom haat.
flan* anancon • man than 1» in long al a dauanc* ' apart*, ana opan Kama. Do not cxncturt or rcnaraw contanar
el 6 n from th* nama. ] Expottr* to lanwaraftfM aeov* 1M* f may eauM tatrang
Al ov«ar pmaixizad aonurm Contana iMa> prauif*. Do not ma or nor* "** naai v opan
toma. Do not punctr* or ranarra coniarar Cipotur* to
lamoarabrai abooa 130* F may cauM bursting
(Bl NOMMttSSUMZIO COMT1MSM
Abova 20' F and not o*ar IO- F
Abov« SO' F and not ovar ISO* F
-j Exnmaty fiammatx*. Kaap away from fir*, aparks. and naaiac
! mrtacm
1 FlammaMa Kaap (way from rtaai and opan (lama.
1 Do not UM or ctora naar naat or optn Aama
(i) Directions for Use—(1) General
requirements—(I) Adequacy and clar-
ity of directions. Directions for use
must be stated in terms which can be
easily read and understood by the
average person likely to use or to su-
pervise the use of the pesticide. When
followed, directions must be adequate
to protect the public from fraud ar.d
from personal Injury and to prevent
unreasonable adverse effects on the
environment.
(li) Placement of directions for use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesiicide provided that:
(A) If required by the Agency, such
printed or graphic matter is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag;
(B) The label bears a reference tc
the directions for use in accompanyint
leaflets or circulars, such as "See di
. rections in the enclosed circular" am
(C) The Administrator determine:
that it Is not necessary for such direc
tions to appear on the label.
(ill) Exceptions to requirement fo
direction for use—(A) Detailed direc
tions for use may be omitted from la
beling of pesticides which are intendec
86
-------
§ 162.10
Tltlt 40—Protection of Environment
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes,
provided that:
U) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type(s) of products involved.
(2) Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product involved and its
proper use in manufacturing process-
es;
(3) The product will not come into
the hands of the general public except
after incorporation into finished prod-
ucts: and
«) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
a) The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(J) The product is also a drug and
regulated under the provisions of the
Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are Intended for
use only by formulators in preparing
pesticides for sale to the public, pro-
vided that:
(1) There is information readily
available to the formulators on the
composition, toxicity, methods of use.
applicable restrictions or limitations.
and effectiveness of the product for
pesticide purposes;
(2) The label clearly states that the
product is intended for use only In
manufacturing, formulating, mixing.
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts involved;
(3) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; and
(<) The Administrator determines
that such directions are hot necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
, (2) Contents of Directions for Use.
The directions for use shall include
the following, under the headings ••Di-
rections for Use":
(i) The statement of use classifica-
tion as prescribed in 162.10(j) immedi-
ately under the heading "Directions
for Use."
(11) Immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling."
(iii) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
. (vi) The method of application, in-
cluding instructions for dilution, if re-
quired, and type(s) of application^)-
paratus or equipment required.
(vil) The frequency and timinl
plications necessary to obtain efnvn-e
results without causing unreasonable
adverse effects on the environment.
(vlii) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(ix) Specific directions concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements of 40 CFR Part 165. These
Instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set in type of the same minimum sizes
as required for the child hazard warn-
ing (See Table in i lB2.10(h)(l)(iv).)
(x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects, such as:
(A) Required intervals between ap-
plication and harvest of food or feed
crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use
on certain crops, animals, objects, or
in or adjacent to certain areas.
(D) [Reserved]
-------
Chapter I—Environmental Protection Agency
§162.11
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(F) Other pertinent Information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(J) Statement of Vte Classification.
By October 22.1976. all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (JX1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with different
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted use
eatonable advene effect*.
hoUi a hearing to
determine whethV «he registration
should be cancelleA/r denied, as ap-
propriate, shall be/aiued, upon a de-
termination by th/ Administrator that
the pesticide meAs orVcceeds any of
the criteria forAisk set forth in para-
graph (aX3) o/this sections Upon such
determination. the Administrator
•hall issue Xotice by certified mail to
the applicant or registrant, asvhe case
may beVtating that the appl
registrant has the opportu
rabmUr evidence in rebuttal of
presymption in accordance with
(aX4) of this section. The app)
It or registrant shall have f orty-fiv!
83
-------
APPENDIX -IV-2
LABELING REQUIREMENTS OP THE F.IFRA, AS AMENDED
.ITEM
i
2
3
n
5
6A
6B
7
7A
7B
IABEL 'EEfMENT
Product name
Company name
and address
Net contents
'EPA'Est. No.
'EPA Reg. No.
.Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
ApmCABILltt
OP REQUIREMENT
All products
All products
All products
All products
All products
All products
liquid products
where dosage
given as Ibs.
al/unit area
All products
All products
All products
PLACEMENT ON IABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
.Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
.limed lately
below child
hazard
warning
COMMENTS
.If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .y etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container Instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked .
Note type size requirements.
Note type size requirements.
-------
APPENDIX .IV-2 (continued)
,nm
7C
7D
7E
8
8A
BB
LABEL 'ELEMENT
Skull & cross-
bones and word
POISON (In red)
Statement of
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
'Environmental
hazards
APPLICABILITY
OP REQUIREMENT
All products
which are Cat-
egory .1 based
on oral, der-
mal, or Inhala-
tion toxlcity
All products
in Categories
•I, .11, and .III
All products
where pre-
cautionary
labeling
appears on
other than
front janel .
All products
All products
in Categories
.1, .11, and .III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category ,1:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
PREMbftRhU
Both In close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
\ i
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
'Environmental hazards Include bee
caution where applicable.
-------
APPENDIX JV-2 (continued)
JTEM
8C
9A
9C
10A
IOC
10D
LABEL 'EO5MENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Re-entry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OP REQUIREMENT
All pressurized
products, others
with flash
points under
150°P
All restricted
products
All products
All
chol ines terase
inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
.Immediately
following
statement of
classifica-
tion or
ahead of
directions
for use
.In the
directions
for use
.In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
.Immediately
after misuse
statement
.Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
.Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Must be set apart and clearly distin-
guishable from from other directions
for use.
May be In metric as well as U.S. units
-------
Appendix JV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
•I. Pressurized Containers
s
A. Flashpoint at or below
20°P; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 Inches from the
valve opening.
C. ALL OTHER PRESSURISED
CONTAINERS
til. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
L. Flashpoint above 20°F
and no.t over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
'Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. 'Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. 'Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. 'Exposure to
temperatures above 130°F
may cause bursting.
'Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
-------
Appendix IV-4
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Size of label
front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
10 and under 6 point
Above 10 to 15 8 point
Above 15 to 30 10 point
Over 30 12 point
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
*" v opened containers), and measures to minimize exposure
while opening or closing container.
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Appendix IV-4
(continued)
4. Instructions on\ what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
B. Pesticide Disposal Instructions;
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food,
or feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance."
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
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Appendix IV-4
(continued)
"
Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance."
Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility. "
3. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original
container in several layers of newspaper and discard in
trash. "
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products intended for domestic use must bear one
of the following container disposal statements:
Container Type _ Statement
[Non-aerosol products
(bottles, cans, iars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
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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
Metal
containers
(non-aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Container Type Statement
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording).
iManufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
2. The labels for all other products must bear container
disposal instructions, based on container type, listed
on the first page of this Appendix.
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Appendix IV-4
(continued)
Pesticides that are hazardous wastes under 40 CFR 261.33(e) and
when discarded.
•Acutely Hazardous" Commercial Pesticides (RCRA "E" Lis*t)
Active Ingredients, (no inerts):
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
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Appendix IV-4
(continued)
•Acutely Hazardous* Commercial Pesticides (RCRA *E" List)
. Active Ingredients continued;
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
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Appendix IV-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3»4-metheno-2H-cyclobuta[c,d]-pentalen-2-one
(kepone, chlordecone)
l,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-DiChlorobenzene
Dichlorodifluoromethane (Freon 12*)
3, 5-Dichloro-N-( 1 ,l-dim.ethyl-2-propynyl) benz amide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (ODD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1,2-Dichloropropane
1,3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
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