GUIDANCE FOR THE
REREGISTRATION OP PESTICIDE PRODUCTS
CONTAINING
AS THE ACTIVE INGREDIENT
PLUOMETURON
Case number; GS-0049
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OP PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460

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TABLE OF CONTENTS
Page
INTRODUCTION 		1
I. Regulatory Assessment 		4
II. Requirement for Submission of Generic Data		21
III. Requirement for Submission of Product-Specific Data ...	43
IV. Submission of Revised Labeling 		45
A.	Label Contents	 45
B.	Collateral Information 		51
V. Instructions for Submission 	 51
i

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APPENDICES
Paee
II-l Guide to Bibliography	55
II-2 Bibliography	57
II-3 PIPRA S3(c)(2)(B) Summary Sheet - EPA Form 8580-1 . .	60
II-4	Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580-2		61
III-l	Product Specific Data Report (End-Use Products) . .	62
IV-1	40 CFR 162.10 Labeling Requirements 		63
IV-2	Table of Labeling Requirements	7 4
IV-3	Physical/Chemical Hazards Labeling Statement.' ...	77
IV-4	Storage and Disposal Instructions 		78

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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA sec. 3(g)) directs the Environmental Protection Agency (EPA)
to reregister all pesticides as expeditiously as possible.
To carry out this task, EPA has established the Registration
Standards program, which will review all pesticide products con-
taining active ingredients first registered before January 1, 1977.
Pesticides will be reviewed in use-clusters which have been ranked
to give earliest review to pesticides used on food and feed crops.
The Registration Standards program involves a thorough review
of the scientific data base underlying pesticide registrations and
an identification of essential but missing studies which may not
have been required when the product was initially registered or
studies that are now considered insufficient. EPA's reassessment
results in the development of a regulatory position, contained in
a Registration Standard, on each pesticide and its uses. The
Agency may require the registrant to modify product labels to
provide additional precautionary statements, restrict the use of
the pesticide to certified applicators, provide reentry intervals,
modify uses or formulation types, specify certain packaging limita-
tions, or other requirements to assure that proper use of the
pesticide will not result in adverse effects on the environment.
The scientific review, which is not contained in this Guidance
Package but is available from the National Technical Information
Service, concentrates on the technical grade of the active
inqredient and identifies missing generic data. However, during
the review of these data we are also looking for potential hazards
that may be associated with the end-use (formulated) products that
contain the active ingredient*. If we have serious concerns, we
will address end-use products as part of the Registration Standards
program and will propose regulatory actions to the extent necessary
to protect the public.
EPA has the authority, under FIFRA sec. 3(c)(2)(B), to require
registrants to submit data that will answer our questions reqardinq
~•he hazard that may result from the intended use of a pesticide,
although sec. 3(c)(2)(B) provides that all registrants are respon-
sible for these data, the Agency generally imposes generic data
requirements only on the registrants of the manufacturing-use
products (basic suppliers of the active ingredient) and other
producers who do not qualify for the formulator's exemption.*
~The formulator's exemption applies to a registrant of a product
if the source of his active ingredient(s)s 1) is a registered'
product, and 2) is purchased from a source which does not have
ownership in common with the registrant's firm.
1

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A producer who wishes to qualify for the formulator's exempti*
may change his source of supply to a registered source, provided
the source does not share ownership in common with the registrant'!
firm. A registrant may do so by submitting a new Confidential
Statement of Formula, .EPA Form 8570-4, identifying the registered
source of the active ingredient, to the appropriate Product Manage!
within 90 days of receipt of this Guidance Document. The chart on
the following page shows what is generally required of those who d<:
and do not qualify for the formulator*s exemption in the Registrati
Standards program.
If you decide to request the Agency to cancel the reqistratior
of any of your products subject to the requirements of this Guidanc
Document, please notify the Product Manager named in the cover
letter, within 90 days from receipt of this document. If you decid
to maintain your the 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 which does
not comply with the requirements set forth in this Guidance Documen
You are reminded that FIFRA sec. 6(a)(2) requires you to submi
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 possib
adverse effects.
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1
| PRODUCTS SUBJECT TO THE
j REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
1
1
|I. Products That Do Not Qualify
For The Formulator's Exemption
A.	Single Active
Ingredient Products*
B.	Multiple Active
Ingredient Products
These products must be reregis-
tered. To obtain reregistra-
tion, labeling, packaging and
data requirements must be
satisfied in accordance with
the Registration Standards
Guidance Document.
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
II. Products That Do Qualify For
The Formulator's Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, including but not
limited to the Label Improvement
Program and special intent to
cancel notices.
* End-use products of registrants who also produce a manufacturing-
use product will not b -equired to be reregistered provided that
registrant fulfills tl.ss ..oquirements 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) based upon an evaluation of the registered products which
contain fluometuron as an active ingredient. Registrations of
substantially similar products will be covered by the requirements
of this Standard. Dissimilar products must be evaluated in order
to be registered and may necessitate amendments to this Standard.
After briefly describing the chemical and Its uses, this chapter
presents the regulatory position and rationale, the criteria for
registration, acceptable ranges and limits and labeling and
tolerance requirements.
In developing its regulatory position, the Agency
determines whether available data indicate that a pesticide
has met the criteria for potential unreasonable adverse effects
in section 162.11(a) of Title 40 of the U.S. Code of Federal
Regulations (CFR). A pesticide meeting the criteria is a candidate
for a Special Review, an intensive risk/benefit analysis. The
Agency's determination as to whether any of the risk criteria
have been met and its rationale for any regulatory action are
summarized in this document.
B. Description of Chemical
Fluometuron is the accepted common name recognized by
the American National Standard Institute (ANSI) for the compound
1,l-dimethyl-3~(alpha,alpha,alpha-trifluoro-m-toly)urea. Its
empirical formula is C10H11F3N2O. The trade names used for
fluometuron are Cotoran® and Lanex®. The Chemical Abstracts Service
(CAS) Registry Number is 2164-17-2. The Office of Pesticide
Programs Chemical Code Number (EPA Shaughnessy Number) is O35503.
Fluometuron is registers por use as a preemergence
and postemergence herbicide for 8-ie-oive control of certain
annual grasses and broadleaf weeds in cotton and.sugarcane.
Cotton accounts for all of the reported use and 90 percent of
the reported use is in the Delta area, which Includes Mississippi,
Louisiana, Arkansas, and Tennessee.
Fluometuron is surface-applied by hand, broadcast, or
banded treatment with up to three applications per season in
cotton and two in sugarcane. In cotton and sugarcane it can be
applied as a preemergence and a postemergence directed or over-
the-top spray, and in cotton as a preplant soil incorporated
and at layby as a directed spray.

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Fluometuron needs rainfall that is sufficient to
germinate the weed seeds for its activation.
Fluometuron is available as a technical material, at
96 percent active ingredient, and at varying percentages as
end-use products. Pluometuron is available in wettable
powders and flowable liquid concentrate end-use formulations.
C. Regulatory Position and Rationale
Based on a review and evaluation of all available data
and other relevant information on fluometuron, the Agency has
made the following determinations.
1.	Registrants must place pre-harvest intervals
on the labels of end-use products containing fluometuron.
These requirements are 60 days for cotton and 180 days for
sugarcane.
Rationale: These pre-harvest intervals will
insure that tolerance levels are not exceeded by the use of
fluometuron. Therefore residues resulting from the use of
fluometuron will be at or below acceptable levels in the
marketable commodities.
2.	Statements which will reduce the possibility
of water contamination must be placed on manufacturing—use products
and end-use products containing fluometuron. These statements
are in section P.
Rationale ? These requirements are necessary
because we lack valid toxicology studies and lack valid fish and
wildlife studies demonstrating the safety of fluometuron to
fish and wildlife.
3. Registrants must place protective clothing statements
on the labels of manufacturing-use and end-use ->ducts containing
fluometuron. The required precautionary state.->;n-j are given in
Section P of this Standard and include items such as coveralls,
long sleeved shirt, shoes, gloves, and eye protection.
Rationale: The toxicology data base for fluoraeturon
indicates that the chemical has a low acute toxicity to mammals
via the oral and dermal routes. However, it does produce severe
skin irritation and induces corneal opacity. The use of appropriate
protective clothing, as required by this Standard, will sufficiently
reduce this risk and provide adequate protection.
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4. Tolerances for significant new food uses will not
be granted until the requested toxicological and residue data
have been received and reviewed.
Rationale: There is cause for concern regarding
residue levels because of an almost complete lack of valid
toxicological data. Current tolerances are expressed in terms
of the parent compound only. The Agency has determined that the
metabolism in plants and animals is not adequately defined.
Available data indicate a need to further clarify the composition
of the terminal residue of fluometuron in plants and animals so
the tolerance expressions regarding metabolites will be appropriate.
5.	The Agency has required the submittal of ground
water data on an accelerated basis. Once the required environ-
mental chemistry data and ground water data from the Data Call-in
program have been evaluated, an assessment for ground water
contamination will be completed. Ground water data consist
mainly of hydrolysis and leaching studies for determination
of the chemical's mobility in the soil.
Rationale: Preliminary data indicate that
fluometuron is moderately to very mobile in a variety of soils,
but the potential for ground water contamination is not well-
characterized. However, the potential for contamination exists.
Therefore, fluometuron was placed on a list of potential ground
water contaminents and ground water data were requested on an
accelerated basis. These data have been received by the agency;
however, our review is not complete at this time.
6.	The Agency has determined that a reentry interval
is not necessary for fluometuron at this time.
Rationale: Available data are insufficient to
fully assess the exposure to field workers at this time.
The Agency beleives that the exposure from reentry will be
minimal in that the only workers reentering the field would
be coyyon scouts. The use involves a directed spray at the
base of the plants . The Agency lacks data to freely assess
the risk to field workers and therefore is calling in additional
exposure data. There are no Federal or State reentry intervals
currently established for fluometuron.
7.	Available data do not show that any of the risk
criteria listed in § 162.11(a) of Title ^0 of the U.S. Code of
Federal Regulations have been met or exceeded for the uses of
fluometuron addressed in this Standard.

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Rationale: The corneal opacity Induced by fluometuron
places the chemical in Toxicity Category I with regard to this
risk. With regard to skin irritation, fluometuron is in Toxicity
Category II. However, the Agency has determined that revised
labeling, in accordance with that required under Toxicity Category
I in 40 CPR § 162.10 (h), and the use of appropriate precautionary
statements, as required in Position #3 of this Standard for eye
and skin irritation, will sufficiently reduce the risk associated
with fluometuron use.
8.	The current label restrictions will be maintained
with regard to crop rotation and prohibiting the feeding of forage
from treated cotton plants and gin trash to livestock. (Refer to
Section P of this Standard.)
Rationale: No tolerances have been established on
meat, milk, poultry, and eggs. As previously stated, residue and
metabolism data on cotton, ruminants, and chickens are being
required. Necessary crop rotation data are also being required
and will be evaluated. These data are needed to evaluate and
assess current tolerances.
9.	The current active ingredient statements on the
label need to be revised.
Rationale; The Agency has determined that the
Para-isomer must be listed in the ingredient statement as an
active separate from the fluometuron Itself because claims
are made on the activity of the isomer. Data in the Agency
files that have been reviewed for this standard included the
isomer. Therefore, data have not been requested on the isomer
alone.
10.	The recommendation for tank mixing with TOLBAN
must be deleted from product labeling.
Rationale: TOLBAN Is no longer registered.
11.	Manufacturing-use and end-use pesticide products
containing fluometuron as a sole active ingredient may be registered
for sale, distribution, reformulation, and use, subject to the
terms and conditions specified in this Standard. Registrants
must provide or agree to develop additional data, as specified in
the tables, In order to maintain existing registrations or to
permit new fluometuron registrations for existing uses. Section 6
of PIPRA authorizes the administrator to cancel a pesticide
registration if he determines that the pesticide will cause
unreasonable adverse effects on the environment. Based on
7

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available data it does not appear that fluometuron poses such
risks. Therefore, registrations may continue in effect while data
required by this standard are being generated. New uses for
fluometuron will only be considered for registration when all
data requirements have been met or a full data package is submitted
with the application.
Rationale; The Agency's data base on fluometuron
is not complete. The Agency requires the data specified in the
tables to complete its analysis of the risks and benefits associate
with continued registration of fluometuron products. Under FIPRA,
the Agency may choose not to cancel or withhold registration if
data are missing or inadequate. [See sections 3(c)(2)(B) and
3(c)(7) of PIPRA.] Rather, issuance of this Standard provides a
mechanism for identifying data needs. These data will be reviewed
and evaluated when they are received and the Agency will determine
at that time if they will affect the registration s) of fluometuron
D. Criteria for Registration Under This Standard.
To be covered by this Standard, products must:
0 be MPs containing fluometuron as the sole active
ingredient, and
° bear required labeling and conform to the product
composition, acute toxicity limits, and use pattern
requirements listed in Sections P and G of this
document.
The applicant for registration or reregistration of
products subject to this Standard must comply with all terras and
conditions described in it. This includes making a commitment to
fill data gaps on a schedule specified by the Agency. Applicants
for registration under this Standard must follow the instructions
contained in this guidance package and complete and submit the
appropriate forms within the time specified.

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E. Acceptable Ranges and Limits
1.	Product Composition Standard
Technical grade products must contain at least
96 percent fluometuron as the sole active ingredient. Each MP
formulation proposed for registration must be fully described
with appropriate certification of limits. In addition, the active
ingredient found in the fluometuron MPs must be substantially
similar to that in currently registered technical products. Any
MPs not meeting these requirements will be considered a new
product and will not be registered under this Standard.
2.	Acute Toxicity Limits
The Agency will consider registration of technical
grade MPs containing fluometuron provided the products are
supported by toxicity data and the labeling for the products bear
appropriate precautionary statements, consistent with the acute
toxicity categories under § 162.10 of CPR.
3.	Use Patterns
To be registered under this Standard, MPs containing
fluometuron must be labeled for formulation into end-use products
that are to be used for control of certain annual grasses and
broadleaf weeds in cotton and sugarcane.
P. Required Labeling
All technical grade.and MPs containing fluometuron must
bear appropriate labeling as specified in MO CFR 162.10. Other
portions of the guidance package contain specific information
regarding label requirements. In addition, the following specific
labeling requirements apply:
1. Labels of all MPs must bear the statement:
a. Use Pattern Statements
For formulation into end-use
herbicide products intended for
use on cotton and sugarcane.

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Do not discharge effluent containing
this product into lakes, streams,
ponds, estuaries, oceans, or public
waters unless this product is specifi-
cally identified and addressed in an
NPDES permit. Do not discharge
effluent containing this product to
sewer systems without previously
notifying the sewage treatment plant
authority. For guidance contact your
State Water Board or regional office
of EPA.
2• Labels of EPs must bear the statements;
a.	Hazards to Humans statements:
Mixer/loader/applicators must wear
protective clothing, consisting of
coveralls, a long-sleeved shirt, shoes,
impermeable gloves, and eye protection
when handling this product.
b.	Environmental Hazard Statements:
The labels of EP's intended for outdoor
use must bear one of the following state-
ments, depending on the formulation of
the product.
Granular products must bear the statement:
Do not apply directly to water or
wetlands. In case of spills, collect
for use or properly dispose of the
granules. Do not contaminate water
by cleaning of equipment or disposal
of wastes.
Nongranular products must bear the statement:
Do not apply directly to water or wetlands.
Do not contaminate water by cleaning of
equipment or disposal of wastes.

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All products must bear the statements;
Cotton:
"Do not feed foliage from treated
cotton plants or gin trash to
livestock
"Do not apply within 60 days of
cotton harvest."
Sugarcane:
"Do not graze treated field with
livestock
"Do not apply within lRO days of
harvest
Phytotoxicity Warnings:
"Do not plant crops other than
sugarcare or cotton within 1 year
after last application or crop
injury may result."
G. Tolerance Reassessment
Tolerances have been established for residues of
fluometuron on cottonseed and sugarcane as listed in 40 CFR
180.229. The toxicology data considered in support of these
tolerances have been determined to be invalid or not acceptable
according to current data requirements. Therefore, a tolerance
reassessment will be completed when these studies are updated
and/or replaced as required by this document (refer to table A).

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EPA Index to Pesticide Chemicals
035503
FLUQMETURON*
TYPE PESTICIDE; Herbicide
FORMULATIONS;
Tech (9o~*j
WP (3OS)
F1C (1.6 lb/gal)
GENERAL WARNINGS AND LIMITATIONS; A selective herbicide used for pre-
emergen.ce and postemergence control of annual broadleaf weeds and grasses
in cotton and sugarcane. Moisture that is sufficient to germinate seeds
or for growing crops is adequate to activate the chemical. Where dry
weather conditions prevail, herbicidal activity may be delayed or reduced.
Apply in 25 to 40 gallons of water per acre. For band applications, re-
duce dosage in proportion to band area actually treated. When tank mixed
with other chemicals, follow directions and precautions given on the
labeling of tank mix chemicals.
DEFINITION OF TERMS;
a.i. * active ingredient
lb * pounds
A " acre
TIME REQUIRED FOR CONTROL; Not located.
PHYT0T0XICITY TO TARGET WEEDS: Not located.
PHYTQTOXICITY TO CROPS; Not located.
MODE OF ACTION: The primary site ox action is inhibition oi the Hill
reaction.
BROADLEAF WEEDS CONTROLLED:
4AABF
FDQAA
1AEBB
VADBD
DAEAB
jAAAB
IAABI
VAJBF
IAFBB
\AABP
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EPA Index to Pesticide Chemicals
FLUOMETURON
BROADLEAF WEEDS CONTRO r,T,F.T): (continued)
"QBSAA	Sesbania
:QAMBF	Sicklepod
£AAGAD	Smartweed
^AAACG	Tumbleweed
2WAKBI	Wright groundcherry
GRASSES AND OTHER MONOCOTS CONTROLLED:
ZABHBB	Barnyardgrass
IABFAA	Crabgrass
3ABCBA	Crowfootgrass
IACEBD	Fall paaicum
2ACUAA	Foxtail
1ABIBA	Goosegrass
3ABZAA	Ryegrass
1AARAA	Signalgrass
Issued! 2-23-84	X—035503—2
13
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EPA Index to Pesticide Chemicals
FLUOMETURON
28007AA
Site, Dosage
and Formulation.
(lb a.i./A)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Cotton
Tolerance, Use, Limitations
1.6
(802 WP)
1-2
<80% WP)
1-2
<802 WP)
(80% WP)
0.1 ppo (cottonseed)
Sixty day preharvest interval.
Do not feed treated foliage or gin trash to live-
stock. Do not make more than 3 applications to
the same crop or field in same year. Do not plant
any crops other than cotton within 6 months of the
last application.
General Information; Applications may be made in
liquid nitrogen fertilizer. May be tank mixed
with or used sequentially to preplant applications
of profluralin; trifluralin; norflurazon; or pen-
dime thalin.
In west TX:, Do not use on sandy, loamy sand or
fine sandy loam soils. Do not use on cotton
planted in furrows.
In AR, LA, and MS: Use 0.8 lb a.i./A on sandy
loam soils low in organic matter content.
In AZ, CA, and NM: Cotton, com, and grain sor-
ghum can be planted the nest spring. Do not plant
treated areas to other crops for 1 year. Do not
use on sandy or coarse textured soils with less
than 1 percent organic matter.
Use limited to AZ, CA, and NM. Preplant. Soil
incorporation. Apply after the beds for preplant
irrigation have been formed, but before the beds
are dragged off. Furrow irrigate prior to plant-
ing. Plant into untreated soil after drag-off and
return treated soil to beds when furrows are re-
formed. Do not allow furrow irrigation water to
pond over the beds.
Preemergence. Broadcast or band. Apply to soil
surface or lightly incorporate.
Postemergence. Directed or over-the-top spray.
Apply when cotton is 3 to 6 inches tall to layby.
Postemergence. At layby. Apply as a directed
spray if needed.
Issued:
2-23-84
1-035503-3
14
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Site, Dosage
and Formulation
(lb a.i./A)
Cotton (continued)
0.8
(1.6 lb/gal F1C)
1-2
(80% WP)
Sugarcane
(Plant Cane)
2-4
(80% WP)
EPA Index to Pesticide Chemicals
FLUOMETURON
Tolerance, Use, Limitations
Postemergence. Directed spray. Direct spray to
base of cotton plants, avoiding the cotton fol-
iage. Apply when cotton is 3 inches tall to first
bloom.
Formulated with MSMA.
Postemergence. Directed spray. Apply when
cotton is 3 inches tall to first bloom.
Tank mix with DSMA or MSMA.
0.1 ppm
0.2 ppm (bagasse)
Do not apply within 180 days of harvest. Do not
graze treated fields with livestock. Do not
apply more than 8 lb a.i./A to the soil during
any 1 year. Do not plant crops other than cotton
or sugarcane within 1 year after last application.
Preemergence. Broadcast. Apply to the soil
surface after planting but before cane and weeds
emerge.
2-4
(802 WP)
(Ratoon Cane)
2-4
(80% WP)
2-4
(80% WP)
Postemergence. Directed or over-the-top spray.
Apply when cane is 12 to 18 inches high and
preemergence to weeds or to weeds less than 2
inches in height.
Preemergence. Broadcast. Apply after harvest
and before new cane shoots and weeds emerge.
Postemergence. Directed or over-the-top srvray.
Apply when cane is 12 to 18 Inches high s
preemergence to weeds or to weeds less ti.<*n ~
inches in height.
Is sued: 2-23-84
1-035503-4
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EPA index to Pesticide Chemicals
FLUOMETURON
Site, Dosage	Tolerance, Use, Limitations
and Formulation
(lb a.i./A)
AERIAL Al'fD TANK MIX APPLICATIONS
300300 Tank Mis
IAAAAA
Refer to
TERRESTRIAL FOOD CROP
(Agricultural"Cropsj
Cotton
Issued: 2-23-84
1-035503-5
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EPA Index to Pesticide Chemicals
FLOOMETURON
Listing of Registered Pesticide Products by Formulation
96.0001 96% technical chemical
fluometuron (035503)
000100-00561 045639-00083
80.0006 80% wettable powder
fluometuron (035503)
000100-00549 000100-00609 045639-00080
01.6014 1.6 lb/gal flowable concentrate
fluometuron (035503) plus monosodium acid methanearsenate (013803)
000100-00553 019713-00127 045639-00079
Issued: 2—23—84	1—035503—6
17
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EPA Index to Pesticide Chemicals
FLUOMETURON
Appendix A
Listing of Common Chemical Names Used on the Entry
Chemical Common Name	EPA Acceptable
Code	(source)	Common/Chemical Name
013802	DSMA	disodium methanearsonate
013803	MSMA	monosodium acid methanearsonate
Issued: 2-23-8A
1-035503-7
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EPA Index to Pesticide Chemicals
FLUOMETURON
Appendix fi
Listing by Site/Pest and Site/Fora/Reg. No.
BROADLEAF WEEDS CONTROLLED:
AAAABF	Buttonweed
3FDQAA	Cocklebur
EMAEBB	Florida piisley
EWADBD	Jimsonweed
3DAEA2	Laobsquarters
3GAAAB	Moruingglory
\AAABI	Pigweed
5AAJBF	Prickly sida
FMAFBB	Puncturevine
VAAABP	Purslane
3FAEAA	Ragweed
3QBSAA	Sesbania
3QAMBF	Sicklepod
iAAGAD	Smartweed
iAAACG	Tumbleweed
iWAHBI	Wright groundcherry
GRASSES AND OTHER MONOCOTS CONTROLLED:
^ABHBB	Barnyardgrass
'ABFAA	Crabgrass
^ABCBA	Crowfootgrass
:ACEBD	Fall panicum
IACUAA	Foxtail
•ABI2A	Goose gras s
^ABZAA	Ryegrass
:AARAA	Signalgrass
TERRESTRIAL FOOD CROP
(Agricultural Crops)
\A Cotton
Pests (see above)
(80% WP)
000100-00549 000100-00609
(1.6 lb/gal F1C)
000100-00553 019713-00127
045639-00080
045639-00079
Issued: 2-23-84
1-035503-8
19
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EPA Index to Pesticide Ch.em1.cals
FLUOMETURON
Appendix B
Listing by Site/Pest and Site/Form/Reg. No.
5003AA	Sugarcane
(Plant Cane)
Pests (see above)
(80% WP)
000100-00549 000100-00609
(Ratoon Cane)
Pests (see above)
(80% WP)
000100-00549 000100-00609
Issued:
2-23-84
1-035503-9
20
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REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document Is a Notice
issued under the authority of FIFRA sec. 3(c)(2)(B). The
tables following this section list the data required for
maintaining the registrability of each product.
EPA has determined that additional generic data described
In Table A must be submitted to EPA for evaluation in order
to maintain in effect the registrations) of your product(s)
identified as an attachment to the cover letter accompanying
this guidance document. As required by FIFRA 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 DatalZ Must be Submitted. You may deter-
mine which generic data you must submit by consulting Table A
at the end of this chapter. That table lists the generic
data needed to evaluate the continued registrability of all
products, and the dates by which the data must be submitted.
The required studies must be conducted in accordance with
EPA approved protocols (such as those contained In the Pesticide
Assessment Guidelines £/ or data collected under the approved
protocols of the Organization for Economic Cooperation and
Development (OECD). If you do not wish to develop data
in support of certain uses appearing in your labeling, you
may aelete those uses at the time you submit your revised
labeling.
For certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a "typical
formulation," and in those cases EPA needs data of that type
A,/ Generic data pertain to the properties or effects of a
particular Ingredient, and thus are relevant to an evaluation of
the risks of all products containing that Ingredient, regardless
of the product's unique composition or specific use. Product-
specific data relate only to the properties or effects of a
product with a particular composition (or a group of products
with closely similar composition).
y The Pesticide Assessment Guidelines are available In hard
copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va. 22161.
21
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for each major formulation category (e.g., emulsifiable concen-
trates, wettable powders, granulars, etc.) These are classified
as generic data and when needed are specified in Table A.
EPA may possess data on certain 11 typical formulations'1 but
not others. Note: "Typical formulation" data should not be
confused with product-specific data (Table B) which are
required on each formulation. Product-specific data are
further explained in Chapter III of this document.
C. Options Available for Complying With Requirements
to Submit Data'
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "FIFRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
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 Into an Agreement With Other Registrants for Develop-
ment of Data" (EPA Form 8580-6, Appendix II—4)*/
V FIFRA sec. 3(c)(2)(B) authorizes Joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to Jointly develop data but fail to agree on all the terras of
the agreement. The statute does not compel any registrant to
agree to develop data Jointly.
(Footnote continued on next page)
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OR
4.	Request that EPA amend your registration by deleting
the uses for which the data are needed. (This option is
not available to applicants for new products.)
OR
5.	Request voluntary cancellation of the registration(s)
of your products for which the data are needed. (This option
is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required data
or how quickly the data must be submitted. If the test
procedures you plan to use deviate from (or are not specified
in) the registration guidelines or protocols contained in
the reports of the Expert Groups to the Chemical Groups,
Organization for Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must submit the protocol
for Agency review prior to the initiation of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted"in writing to the Product Manager.
(Footnote continued from previous page)
In EPA's opinion, Joint data development by all regis-
trants subject to a data requirement or a cost-sharing agreement
among all such registrants is clearly in the public interest.
Duplication of testing could increase costs, tie up testing
facilities, and subject an unnecessarily 1 %e number of
animals to testing.
As noted earlier, EPA has discretion to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). EPA has concluded that
it should encourage Joint testing rather than duplicative
testing, and that suspension should be withheld in certain cases,
to further this goal. Accordingly, if (1) a registrant has
informed us of his Intent to develop and submit data required
by this Notice; and (2) a second registrant informs EPA that
it has made a bona fide offer to the first registrant to share
in the expenses of the testing [on terms to be agreed upon
or determined by arbitration under FIFRA Section 3(c)(2)(B)(iii)];
and (3) the first registrant has declined to agree to enter
into a cost-sharing agreement, EPA will not suspend the
second firm's registration.
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The extension request should state the reasons why you believe
that an extension is appropriate. While EPA considers your
request, you must strive to meet the deadline for submitting
the required data.
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TABIE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: FLUOMETURON
Guideline Citation and
Name of Test
Test Guidelines
Substance 1/ Status
Are Data
Required
Yes	No
Footnote
Number
Data Must Be
Submitted Within
Timeframe Listed
Below 2/
§158.120 Product Chemistry
Product Identity:
61-1 - Identity of Ingredients	TGAI
61-2 - Description of Beginning Materials TGAI
and Manufacturing Process
61-3	- Discussion of formation of	TGAI
Impurities
Analysis and Certification of Product
Ingredients
62-1	- Preliminary Analysis	TGAI
62-2 - Certification of Limits TGAI
62-3	- Analytical Methods to Verify	TGAI
Certified Limits
Physical and Chemical Characteristics
63-2	- Color	TGAI
63-3 - Physical State	TGAI
63-1 - Odor	TGAI
63-5 ~ Melting Point	TGAI
63-6 - Boiling Point	TGAI
R
R
R
R
R
R
R
R
R
R
R
n
O
n
o
ra
[X]
0
0
O
0
n
[X]
m
m
0
0
[X]
Gp
m
m
m
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: FLUOMETURON
Guideline Citation and
Name of Test
Test	Guidelines
Substance 1/ Status
Are Data
Required
Yes	No
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63—7 - Density, Bulk Density, or
Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-H - Octanol/Wciter Partition
Coefficient
63-12 - pH
63-13 - Stability
Other Requirements:
61!- 1 - Submittal of samples
TGAI	R
TGAI or PAI	R
PAI	R
PAI	R
PAI	R
TGAI	R
TGAI	R
TGAI, PAI	CR
O
O
o
[X]
0
O
O
ra
[X]
[X]
m
[J
[X]
[X]
m
CI
Fbotnote
Number
Data must Be
Submitted Within
Timeframe Listed
Below 2/
7 Months
7 Months
1/ TGAI = Technical Grade of the Active Ingredient; PAI = Pure Active Ingredient; R = Required; CR = Conditionally Requlr
2/ Data must be submitted within the indicated timeframe, based on.the date of the Guidance Document.
0 7-Month Due Date is	 .
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3
TABLE A
GENERIC DATA REQUIREMENTS FOR FLUOMETURON
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
1/	Requirement? (Yes,
Jb, or Partially)
Bibliographic
Citation
Hist Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Timeframe ft>r Data
Submission 2/
§158.125 Residue Chemistry
171-2 - Chemical Identity
171-3 - Directions for Use
171—^ - Nature of Residue (Metabolism)
-	Plants (Cotton, Sugarcane)
-	Livestock
171-4 - Residue Analytical Method
-	Plant Residues
-	Animal Residues
171-4 - Magnitude of the Residue-
Residue Studies for Each
Fbod Use
o Crop 1, Cotton
—	Crop Field Trials
—	Processed Food/Feed
—	Meat/Milk/Poultry/Efegs
TGAI
PAIHA
PAIRA and Plant
Metabolites
TQAI and Metabolites
TGAI and Metabolites
1EP
IBP
TGAI or Plant
Metabolites
Yes
Yes
No
to
Rartlally
Pratially
Rartlally
Partially
No
CSF
label
00019009
00022940
00019160
00019014
00019021
00019099
No
No
Yes
Yes
Yes
Yes
25 Months
13 Months
25 Months
13 Manths
Yes	16 Months
Yes	19 Months
Yes	16 Months

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TABIE A
GENERIC DATA REQUIREMENTS FOR FLUOMETURON
Does EPA Have Data	Must Additional Data
To Satisfy Ms	Be Submitted Under
1/ Requirement? (Yes, Bibliographic	FIFRA § 3(c)(2)(B)?
Data Requirement Composition No or Partially)	Citation Timeframe for Data
		Submission iL
§158.125 Residue Chemistry - Continued
171-4 - Magnitude of the Residue -
Residue Studies (continued)
o Crop 2, Sugarcane
- Crop Field Trials
TEP
No
Yes
16
Months
- Processed Fbod/fleed
TEP.
Nd
Yes
19
Manths
- Meat/Milk/Poultry/Efegs
TCAI or Plant
No
Yes
16
Months
Metabolites
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TABLE A
GENERIC DATA REQUIREMENTS FOR FLUOMETURON
§156.125 Residue Chemistry - Continued
\f Composition: TQAI = Technical grade of the active ingredient; PA IRA = Pure active Ingredient, radiolabeled; TEP =
Typical mi-use product; EP = Bid-use product.
dj Data must be submitted within the indicated timeframe, based on the date of the Guidance Document.
0 7-ttfith Due Date is	.
0 13-Month Due E&te is	.
0 16-Month Due Date is	.
0 19-Month Due Date is	.
0 25-Month Due Date is	.
v0
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TABLE A
GENERIC DATA REQUIREMENTS FOR FLUOMETURON
Does EPA Have Data	Must Additional
To Satisfy Hiis	Data Be Submitted
1/ Use 2/ Requirement? (Yes,	Bibliographic Under FIFRA Section
Data Requirement	Composition Pattern	No or Partially)	Citation	3(c)(2)(B) 3/	
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:





l6l-l - Hydrolysis
TGAI or PAIRA
A
Jb
Yes
6 months
Photodqgradat ion





161-2 - In Water
THAI or PAIRA
A
No
Yes
6 months
161-3 - On Soil
TGAI or PAIRA
A
No
Yes
6 months
161-4 - In Air
TGAI or PAIRA
A
No
Waived1'
METABOLISM STUDIES-LAB:





162-1 - Aerobic Soil
TGAI or PAIRA
A
No
Yes
2 years
162-2 - Anaerobic Soil
TGAI or PAIRA
A
No
Yes
2 years
162-3 - Anaerobic Aquatic
TGAI or PAIRA
None
No
No

162-4 - Aerobic Aquatic
TGAI or PAIRA
None
No
No

MOBILITY STUDIES:





163-1 - Leaching and
Adsorptlon/Desorption
TGAI or PAIRA
A
I&rtially
00044017,05012167 Yes9
6 months
163-2 - Volatility (Lab)
TCP
A
No
Waived*1
16V3 - Volatility (.Fields
TEP
A.
No
Waived1'
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TABLE A
GENERIC DATA REQUIREMENTS FOR FLUQMETURON
Data Requirement
Composition
1/
Use 2/
Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Re Submitted
Under PIFRA Section
3(c)(2)(B)?3/
§158.130 Environmental Fate
(continued)
DISSIPATION STUDIES-FIELD:.
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination arri
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 Nontarget
Organisms
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
TEP
Subpart K Reentry
Foliar Dissipation
Soil Dissipation
Inhalation Exposure
Dermal Exposure
A
None
None
A
None
A
A
A
A
A
A
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes 2 years
No
No
Reserved5
Reserved^1
Yes 2.5 years
Reserved7
No
Yes 6 months
No
Nob
No8
N08
N08
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(continued)
1/ Composition: TGAI = Technical grade of the active Ingredient; PA IRA = Pure active Ingredient, radiolabeled,
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Pood Crop; B = Terrestrial, Nonfood; C = Aquatic, Pood Crop;
D = Aquatic, Nonfood; E = Greenhouse, Food Crop; P = Greenhouse, Nonfood; G = forestry; H = Domestic Outdoor; I = Indoor.
3/ Data must be submitted no later than the date indicated in the ground water data call-in letter sent previously, since
the Agency has a concern about the leaching potential of flucmeturon and has requested hydrolysis, photodegradatlon,
metabolism, mobility, and field dissipation data on an accelerated basis. Ground water data call-in notice sent on
June 19, 1984, for hydrolysis, photodegradatlon in water and soil, aerobic and anerobic soil metabolism, mobility, and
field dissipation. Existing data submitted for the above studies In September 1984. Hard copies are being assessed
for comparison with the studies reviewed for the Registration Standard. Any studies not reviewed will be reviewed and
evaluated. An addendum will bt ^epared, if necessary, to report additional data.
V TMs data requirement is waiver* ;cause flucmeturon has a low vapor pressure.
5/ Not required at this time because this Standard deals only with single active ingredient products.
5/ May be required, depending on results of 161-1, Tterrestrlal Pleld Dissipation.
7/ May be required, depending on results of 165-1, Confined Rotational Crop Study.
8/ This requirement is not being imposed at this time because it is assumed the only exposed workers reentering the
field after flucmeturon application are cotton scouts, and since the usage involves a directed spray at the
cotton stalk base, exposure is assuned to be minimal.
9/ Ihese two studies partially fulfill data requirements by giving the mobility of fluometuron In silty clay loam.
Additional studies are required to establish the mobility in three additional soils and the mobility of fluometuron
degradates (fluometuron aged residues) in a sandy loam soil. Adsorption/desorption (batch equlllbriun) studies
are preferred.
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TABLE A
GENERIC DATA REQUIREMENTS FOR FLUOMETURON
Data Requirement
1/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Fata Be Submitted
Under FIFRA Section
3(c)(2)(B) 3/
§1^8.135 Toxicology
ACWE TESTING:
81-1 - Oral LD$o - Rat	TCAI
81-2 - Dermal LD^q	TCAI
81-3 - Inhalation IC50 - Rat TCAI
81-7	- Acute Delayed
Neurotoxicity - Hen	TCAI
SUBCHRONIC TESTING:
82-1	- 90-Day Feeding -
Rodent, Non-rodent	TGAI
82-2 - 21-Day Dermal	TCAI
82-3 - 90-Day Dermal	TGAI
82-4 - 90-Day Inhalation -	TGAI
82-5 - 90-Day Neurotoxicity -
Hen or Manmal	TGAI
A
A
A
A
A
A
A
Yes
Yes
Yes
Yes
Yes
hb
No
No
No
00019028
00019206
00019207
00019207
00019031*
00019035
No
No
No
No
No
Yes 6 months
Reserved V
Reserved V
Reserved V
1/ Composition: TGAI = Technical grade of the active Ingredient.
2/ The use patterns are coded as follows: A = Terrestrial, Fbod Crop; B = Terrestrial, Nonfood; C = Aquatic, Food Crop;
~ D = Aquatic, Nonfood; E = Greenhouse, Fbod Crop; F = Greenhouse, Nonfood; G = Fbrestry; H = Domestic Outdoor;
I = Indoor.
3/ Data must be submitted no later than	.
£4 Data not required at the present.
O*
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TABLE A
GENERIC DATA REQUIREHEWTS FOR FLUOMETURON
Data Requirement
1/ Use 2/
Composition 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)
§158.135 Toxicology
(Continued)
CHRONIC
ONCOGENICITY TESTING: 3/
83-1 Chronic Toxicity -
2 species: Rodent
annd Non-Rodent
83-2 Oncogenicity Study -
2 species: Rat and
Mouse preferred
83-3 Teratogenicity -
2 species
83-4	Reproduction,
2 generation
MUTAGENICITY TESTING:
8*4-2 Gene Mutation
84-2	Chranosal Aberration
84-2 Other Mechanlans of
Mutagenicity
TGAI
TGAI
TGAI
TCAI
TGAI
TGAI
TGAI
A
A
No
No
Fcirtlally
No
No
No
No
Yes	4 years i!/
Yes	4 years V
Yes	9 months
Yes	2.5 years
Yes	6 months
Yes	6 months
Yes	6 months
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TABLE A
GENERIC DATA REQUIREMENTS FOR FLUOMETURON
Data Requirement
Composition"
1/
Use 2/
Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under PIPRA Section
3(c)(2)(B) V
§158.135 Toxicology
(Continued)
SPECIAL TESTING:
85-1 - General Metabolism
85-2 - Domestic Animal Safety
A
A
No
tto
Yes 1 year
No
1/ Composition: TGAI = Technical grade of the active ingredient.
2/ Hie use patterns are coded as follows: A = Terrestrial, Fbod Crop; B = Terrestrial, Nonfood; C = Aquatic,
Pood Crop; D = Aquatic, Nonfood; E = Greenhouse, Fbod Crop; P = Greenhouse, Nonfood; G = Forestry;
H = Domestic Outdoor; I = Indoor.
3/ Data must submitted no later than
Tlie^fe^^on^lhas performed carcinogenicity studies that may meet Agency requirements for
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TABLE A
GENERIC DATA REQUIREMENTS FOR FLUOMETURON
Does EPA Have Data Must Additional
To Satisfy Hiis Data Be Submitted
1/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement	Composition Pattern	No or Partially)	Citation	3(c)(2)(B)?3/
143—1 - NONTARGET INSECT TESTING-
thru ffiEDATORS AND PARASITES
143-3	[Reserved]!/
1/ Canposition: TQAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic, Food Crop;
D = Aquatic, Nonfood; E = Greenhouse, Food Crop; *F = Greenhouse, Nonfood; G = Forestry; H = Domestic (Xitdoor;
I = Indoor.
3/ Data must be submitted no later than	.
T\/ As data from acute contact test indicate low toxicity, data on residual toxicity are not required.
5/ Requirement reserved pending development of test methodology.
t/ Requirement applied on a case-by-case basis. Data reviewed to date do not indicate the need for a field study.
7/ Reserved pendlr£ Agency decision as to whether the data requirement should be established.
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TABLE A
GENERIC DATA REQUIREMENTS FOR FLUCMETURON
Does EPA Have Data	Must Additional
To Satisfy Ihis	Data Be Submitted
1/ Use 3/ Requirement? (Yes,	Biblicgpaphic	Under PIPRA Section
Data Requirement	Composition Pattern	No or Partially)	Citation	3(c)(2)(B) 3/	
§158.145 Wildlife and
Aquatic Oceanians
Avian and Mammalian Testing
71-1 - Avian Oral LDfcjQ
71-2 - Avian Dietary LCcn
71-3 - Wild Maranal "toxicity
71-1 - Avian Reproduction
71-5 - Simulated and Actual
Field Testing - Manmals
& Birds
Tech	A	Yes	00019221 No
Tech	A	Yes	00019222 No
N/A
N/A
N/A
Aquatic Organisms Testing
72-1 - Freshwater Fish LCcq
72-2 - Acute IJC50 Freshwater
Invertebrates
72-3 - Acute LCcfl Estuarlne
and ferine Organisms
72-1 - Fish Early Life-stage
and Aquatic Invertebrate
Life Cycle
Fish Life Cycle
Aquatic Organisms
Accumulation
72-7 - Simulated or Actual Field
	Testing - Aquatic organisms
72-5
72-6
Tech
Tech
Tech
N/A
N/A
N/A
N/A
A
A
Yes
Yes
No
2139-110
00024180
Yes3/ 6 months
No
Reserved
V

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1/ Composition of the material to be tested Is technical grade unless otherwise specified In footnotes.
2/ The use patterns are coded as follows: A = Terrestrial, Pood Crop; B = Terrestrial, Nonfood; C = Aquatic, Food Crop
Nonfood; E = Greenhouse, Food Crop; P = Greenhouse, Nonfood; G = Forestry; H = Domestic Outdoor; I = Indoor.
3/ Due to present registration of only one end-use product the cold water fish requirement is satisfied with the 80% WP;
however, warm water requirements must be fulfilled. If additional products are registered, another cold water fish
study Mi the technical may be required.
V Cotton and Sugarcane are grown In coastal counties in excess of 300,000 acres. Pending the results of the warm water
fish studies and envlrormental fate data these studies could be required.
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TABLE A
GENERIC DATA REQUIREMENTS FOR FLUOMETURON
Data Requirement
§158.110 Reentry Protection
132-1 - Foliar Dissipation
132-1	- Soil Dissipation
133-3	- Dermal Exposure
133-4 - Inhalation Exposure
§158.142 Spray Drift
201-1 - Droplet Size Spectrin
201-1 - Drift Field Evaluation
1/ Use 2/
.^position Pattern
TEP
TEP
TEP
TEP
TEP
TEP
A
A
A
A
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Noil/
Noi!/
Noi!/
No4/
No
Nd
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
No
No
No
No
No
No
1/ Composition: TEP = Typical end-u3e product.
2/ The use patterns are coded as follows: A = Terrestrial, Rood Crop; B = Terrestrial, Nonfood; C = Aquatic,
Fbod Crop; D = Aquatic, Nonfood; E = Greenhouse, Pood Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic
Outdoor; I = Indoor.
3/ Data must be submitted within the indicated timeframe, based on the date of the Guidance Document.
0 25-Month Due Date Is	.
V This requirement Is not being Imposed at this time, because it is assimed the only exposed workers reentering
the field after fluaneturon application are cotton scouts, and since the usage Involves a directed spray at the
cotton stalk base, exposure is assimed to be minimal.
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III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: Unless stated otherwise in Section I, Regulatory
Position and Rationale, this Section applies only to manufac-
turing use products, not to end use products.
A necessary first step in determining which statements
must appear on your product's label is the completion and
submission to EPA of product-specific data* listed on the
form entitled "Product Specific Data Report" (EPA Form
8580-4, Appendix III-l) to fill gaps identified by EPA
concerning your product. Under the authority of FIFRA sec.
3(c)(2)(B), EPA has determined that you must submit these
data to EPA in order to reregister your product(s). All of
these data must be submitted not later than six months after
you receive this guidance document.
Table B—Product-Specific Data Requirements for Manufacturing
Use Products—lists the product specific data you must submit.
Data that are required to be submitted are identified in the
column of those tables entitled "Must Data By Submitted
Under S3(c)(2)(B)."
Product specific data pertain to data that support the
formulation which is marketed? it usually includes product
chemistry data and-acute t^icity data.
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING: FLUCMETURON
Guideline Citation and
Name of Test
Ttest Guidelines
Substance 1/ Status 2/
Are Data
Required
Yes No
Footnote
Ntmber
Data Must Be
Submitted Within
Timeframe Listed
Below 3/
§158.120 Product Chemistry
Product Identity:
61-1 - Product Identity and Disclosure MP
of Ingredients
61-2 - Description of Beginning Materials MP
and Manufacturing Process
61-3	- Discussion of formation of	MP
Impurities
Analysis and Certification of i iuct
Ingredients
62-1	- Preliminary Analysis	MP
62-2 - Certification of Limits MP
62-3	- Analytical Methods to Verify	MP
Certified Limit
Physical and Chemical Characteristics
63-2	- Color	MP
63-3 - Physical State	MP
63-4 - Odor	MP
R
R
R
CR
R
R
R
R
R
O
O
n
n
O
m
o
o
[ ]
m
W
[X]
ra
m
n
np
m
[X]
13 Months
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING: FLUCMETURON
EPA REGISTRATION NUMBER 100-561 (95% T) V,5/
Guideline Citation and
Name of Teat
Test Guidelines
Substance 1/ Status 2/
Are Data
Required
Yes No
Footnote
Number
Data must Be
Submitted Within
Timeframe Listed
Below 3/
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or	MP
Spec if ic Gravity
63-12 - pH	MP
Other Requirements;
6*1—1 - Submittal of samples	MP
R
CR
CR
O
O
®
m
[X]
n
7 Months
1/ MP = Manufacturing-use Prudi
2/ R= Required; CR = Conditions Required.
3/ Data must be submitted within the indicated timeframe, based on the date of the Guidance- Document.
0 7-Month Due Date is
0 13-Month Due Date is	.
V Hie 96% technical (T) also serves as an MP.
S/ This technical is sold to Nor-Am as an MP. The registration number for ttie MP is 15639-83.
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TABUS B
FRODUCT-SPECIPIC DATA REQUIREMENTS FOR MANUPACTURING-USE PRODUCTS CONTAINING FLUOMETURON
Data Requirement
Composition
1/
Rxjs 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)?3/
§158.27 Toxicology
ACUTE TESTING:
81-1 - Oral LEfcjo - Rat	MP
81-2 - Dermal LE^q	MP
81-3 - Inhalation LC^ - Rat	MP
81—i| - Primary Eye
Irritation - Rabbit	MP
81-5 - Primary Dermal	MP
Irritation
8l-6 - Dermal Sensitization
and Photosensltlzatlon MP
Yes
Yes
Yes
Yes
Yes
Rartlally
00019028
00019206
00019207
00068038
00068040
00019218
No
No
No
No
No
Yes 6 months
1/ Composition: MP = Manufacturing-use product.
2/ Data must be submitted no later than	
-t*.
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IV. SUBMISSION OF REVISED LABELING
Note: This section applies to all products.
PIFRA 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 IV-1) and are summarized for products containing
this active ingredient as part of this Guidance Document
(See Appendix IV-2). Applications submitted in response to
this notice must include draft labeling for Agency review.
If you fail to submit revised labeling information
complying with this section (supplemented by requirements
described In Section I, Regulatory Position and Rationale),
EPA may issue a notice of intent to cancel the registration
under PIPRA sec. 6(b)(1).
A. Label Contents
40 CPR 162.10 requires that certain specific labeling
statements appear at certain locations on the label . This
is referred to as format labeling. Specific label items
listed below are keyed to Appendix IV-2.
Item- 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item NET CONTENTS - A net contents statement is
required on all labels or!on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. See Appendix IV-1. [40 CPR
162.10(d)]
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Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix -IV-1.
[40 CPR 162.10(e)]
Item 5• EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
See Appendix IV-1. [40 CPR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert Ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. See Appendix IV-1. [40 CPR
162.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label
on Front Panel
In Square Inches
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Signal Word
Minimum Type Size
All Capitals
6 point
10 point
12 point
14 point
18 point
"Keep Out of Reach
of Children"
Minimum Type Size
6 point
6 point
8 point
10 point
12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. See Appendix IV-1.
[40 CFR 162.10(h)(1)(ii)]
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Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. See Appendix IV-1.
[40 CPR 162.10 (h)(1)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. See Appendix IV-1. [40 CPR 162.10(h)(1)(i)]
Item 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 I,
II, and III. See Appendix IV-1. [40 CPR 162.10(h)(1)(iii) ]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
See Appendix IV-1. [40 CPR 162.10(h)(1)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix IV-1. [40 CPR 162.10
(h)(2)].
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. See Appendix IV-1. [40 CPR 162.10
(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix IV-1. [40 CPR
162.10(h)(2)(ii)]
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Item 8C. PHYSICAL OR CHEMICAL HAZARD
I. Flammability statement. Precautionary statements relating
to flammability of a product are required to appear on the
label if it meets the criteria in Appendix IY-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.
d. 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:
i.	The flame extension is zero inches;
ii.	There is no flashback; and
iii.	The flashpoint of the non-volatile liquid
component is greater than 350°P (177°C).
3. Declaration of non-flammability. Products which
meet the criteria for non-flammability specified
above may bear the notation "non-flammable" or "non-
flammable (gas, liquid, etc.)" on the label. It may
appear as a substatement to the ingredients statement,
or on a back or side panel, but shall not be highlighted
or emphasized (as with an inordinately large type
size) in any way that may detract from precaution.
i|. Other physlcal/chemfcal 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.
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Item 9A. RESTRICTED USE CLASSIFICATION - PIPRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by: certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) Indicated
certain formulations/uses are to be restricted (Section I
indicates why the product has been c-lassifled for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162 .11(c) . You will be notified of
the Agency's classification decision.
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1.	Front panel statement of restricted use classification.
a.	The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label.
The statement must be set in type of the same
minimum size as required for human hazard signal
• -rd (see table in 40 CFR 162.10(h)(1)(iv)
b.	Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if
specified in Section I). If use is restricted to
certified applicators, the following statement is
required: "For retail sale to and use only by
Certified Applicators or persons under their direct
supervision and only for those uses covered by the
Certified Applicator's Certification."
2.	Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
-------
a.	You may label the product for Restricted use.
If you do so, you may Include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b.	You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c.	You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B [There is no Item 9B].
Item 9C. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29. 1983-
Item 10B [There is no Item 10B].
Item IOC. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These Instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child sard warning. Refer to Appendix
IV-4, IV-5, and IV-6 t, u ^ermine the storage and disposal
instructions appropriate for your products.
Item 10D. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix IV-1. [40 CFR 162.10]
49
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B. Collateral Labeling
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to 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.
V. INSTRUCTIONS FOR SUBMISSION
A. For Manufacturing Products (MP) containing Fluometuron
as sole active ingredient.
1.	Within 90 days from receipt of this document, you must
submit to the Product Manager in the Registration Division at
the address given at the end of this section the "FIFRA Section
3(c)(2)(B) Summary Sheet" EPA Form 8580-1. Refer to Appendix
II-3 with appropriate attachments.
If on. the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit "protocols or modifie<3
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This information should be submitted
to the Office of Compliance Monitoring at the address given at .
the end of this section. (Actual studies are not to be submitted •'
2.	Within 6 months from receipt of this document you must
submit to the Product Manager, on the Registration Division:
a.	Confidential Statement of Formula, EPA Form 8570-4.
b.	Product Specific Data Report, EPA Form 8580-^
(Appendix III-l).
c.	Two copies of any re Ired product-specific data
(See Tables B).
d.	Two copies of draft labeling, Including the label an*3
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, you may submit such labeling. End use .
product labeling must comply specifically with the instruction
in Section I (Regulatory Position and Rationale) of this
guidance document. The labeling should be either typewritten
-------
text on 8-1/2 x 11 inch	paper or a mockup of the labeling
suitable for storage in	8-1/2 x 11 inch files. The draft
label must indicate the	intended colors of the final label,
clear indication of the	front panel label, and the intended
type sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(1)(D). Refer to 40 CFR 152.80-152.99
for latest requirements.
3. Within the times set forth in Table A, you must submit
to the Registration Division all generic data, unless you are
eligible for the formulator's exemption. If for any reason any
test is delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
B. For Manufacturing Use Products containing Fluometuron
in combination with other active ingredients
1.	Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet," EPA Form
8580-1. Refer to Appendix II-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a data
requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
2.	Within the times set forth in Table A, you must submit
to the Registration Division all generic data, unless you are
eligible for the formulator's exemption. If for any reason any
test is delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
51
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C. For End Use Products containing Fluometuron alone
or In combination with other active Ingredients:
1.	Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet," EPA Form
8580-1. Refer to Appendix II-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit protocols or modlfi®d
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.'
2.	Within 6 months from receipt of this document you must
submit:
a.	Confidential Statement of Formula, EPA Form 8570-4.
b.	Product-Specific Data Report, EPA Form 8580-4
(Appendix III-l), if applicable (if Table C lists required
product-specific data).
c.	Two copies of any required product-specific data,
if applicable (if Table C lists required product-specific
data).
d.	Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, you may submit such- labeling. End use
product labeling must comply specifically with the instruction9
in Section I (Regulatory Position and Rationale) of this
guidance document. Labeling should be either typewritten
text on 8 1/2 x 11 inch paper or a mockup of the labeling
suitable for storage in 8 1/2 inch files. The draft label
must Indicate the intended colors of the final label, c ar
indication of the front panel label, and the intended -yi.-
sizes of the text.
3. Within the time frames set forth in Table A, submit all
generic data, unless you are eligible for the formulator's
exemption.
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D. For intrastate products containing Fluometuron
either as the sole active Ingredient or in combination
with other active Ingredients
These products are being called in for full Federal
registration. Producers of these products are being sent
a letter instructing thera how to submit an application for
registration.
E. Addresses
Applications and other required information should be
submitted to the following address:
Product Manager 25
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW.
Washington, D.C. 20460
Phone No. (703) 557-1800
The address for submission to the Office of Compliance Monitoring
is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW.
Washington, D.C. 20M60
53
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Appendix II-1
Guide to Use of This Bibliography
1.	CONTENT OP BIBLIOGRAPHY- This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2.	UNITS OF ENIRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3.	IDENTIFICATION OP ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit'"Accession Number"
which has been used to identify volumes of sutmitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4.	FCRM CP EMERY. In addition to the Master Record Identifier
(MFJD), each entry consists of a citation containing
standard elements followed, in the case of material
sutmitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
-------
Appendix H-l (continued)
a.	Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b.	Docunent Date. When the date appears as four digits
with no question marks, the Agency took it directly
frcm 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 docunent.
c.	Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial Insertions are contained
between square brackets.
d.	Trailing Parentheses. Fbr studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1)	Submission Date. The date of the earliest known
submission appears Inmedlately following the word
"received."
(2)	Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3)	Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4)	Volume Identification (Accession Numbers). The
final element In the trailing parentheses
identifies the EPA accession number of the volune
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is In turn
followed by an alphabetic suffix which shows the
relative position of the study within the volune.
For example, within accession number 123^56, the
first study would be 123^56-A; the second, 123^56-
B; the 26th, 123^56-Z; and the 27th, 123^56-AA.
55
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OFFICE OP FESTICIEE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard For Flucmeturon
MRIL)	Citation
00006653 Atkins, E.L., Jr.; Anderson, L.D.; Nakakihara, H.; Greywood, E.A.
(1970) Toxicity of Pesticides and Other Agricultural Chemicals
to Honey Bees; Laboratory Studies. Rev. By Univ. of Califor-
nia, Dept. of Ehtcraology. Riverside, Calif.: U.C. (Agricul-
tural Extension M-16; also in unpublished submission received
Nov 17, 1975 under 359-620; submitted by Rhone-Poulenc, Inc.,
Mormouth Junction, N.J.; CEL.-223344-B)
00019009 Baunok, I.; Geissbuehler, H. (1968) Specific determination of urea
herbicide residues by EC gas chromatography after hydrolysis and
Iodine derivative formation. Bulletin of Envirormental Contam-
ination & Toxicology 3(1):11-21. (Also in unpublished submis-
sion received Sep 11, 1978 under 241-243; submitted by American
Cyanamid Co., Princeton, N.J.; ClX:235084~O)
00019014 Dure, P. (1964) Residue Analysis of C-2059, N'-G-Trifluorcmethyl)-
phenyl-N1,N-dimethylurea, with Special Reference to Cottonseed.
Method dated Sep 12, 1964. (Unpublished study received Sep 12,
1964	under unknown admin, no.; prepared by Wisconsin Alunni
Research Foundation, submitted by Ciba Agrochemical Co., Sunmit,
N.J,; CCL:124540-A)
00019021 Wisconsin Alunni Research Foundation (19??) Storage Study with
Cotoran Treated Cottonseed. (Unpublished study received Sep 23,
1965	under 8192-5; submitted by Ciba Agrochemical Co., Sunmit,
N.J.; CDL:007075-C)
00019028 Fogleman, R.W. (1964) Compound C-2059 Technical—Acute Oral Toxici-
ty on Male and Female Rats: Project # 20-042. (Unpublished
study received May 11, 1965 under 8192-5; prepared by AME Asso-
ciates, submitted by Ciba Agrochemical Co., Sunmit, N.J.; CDL:
007071-G)
00019034	Fogleman, R.W. (1965) Cotoran—90-Day Feeding—Rats: Project # 20-
042. (Unpublished study received May 11, 1965 under 8192-5;
submitted by Ciba Agrochemical Co., Sunmit, N.J.; CEL:007071-N)
00019035	Fogleman, R.W. (1965) Subacute Toxicity—90 Day Administration—
Dcgs: Project # 20-042. (Unpublished study received May 11,
1965 under 8192-5; prepared by AME Associates, submitted by Ciba
Agrochemical Co., Summit, N.J.; CEL:007071-0)
00019099 Thompson, J.T.; Hardcastle, W.S.; Frans, R.E.; et al. (1965) Re-
sults of Tests on the Amount of Residues Remaining, Including a
Description of the Analytical Methods Used: [Cotoran]. (Unpub-
lished study received Jun 15, 1967 under 6F05O5; submitted by
Ciba Agrochemical Co., Summit, N.J.; CDL:090591-T)
-------
CEFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard For Flucmeturon
MRID	Citation
00019160 Geissbuhler, H.; Haselbach, C.; Jacot-Guillannod, A. (1964) Residue
Analysis of Preparation C-2059, N1-(3-Trif1uorcroethyl)-pheny1-
NN-dimethylurea, in Soils and Plant Tissues. Includes method
dated Jan 15» 1964. (Unpublished study received Oct 8, 1964 un-
der 100-549; prepared by Battelle Memorial Institute for Ciba-
Gelgy, AG, submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
007070-P)
00019206	Paa, H. (1977) Report to Ciba-Geigy Corporation; Acute Dermal Tox-
icity Study with Cotoran (R) 80WP in Albino Rabbits: IBT
No. 8530-10433. (Unpublished study received Jun 22, 1978 under
100-549; prepared by Industrial Bio-Test Laboratories,. Inc.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CEL:234l72-C)
00019207	Qgorzaby, C. (1977) Report to Ciba-Geigy Corporation: Acute Dust
Inhalation Toxicity Study in Rats: IBT No. 8562-10432. (Unpub-
lished study received Jun 22, 1978 under 100-549; prepared by
Industrial Bio-Test Laboratories, Inc., submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:234172-D)
0CT019218 Brett, B. (1975) Report to Ciba-Geigy Corporation: Skin Sensitiza-
tion Test with Cotoran (R) Technical in Albino Guinea Pigs: IBT
No. 601-06460. (Unpublished study received Jun 22, 1978 under
100-561; prepared by Industrial Bio-Test Laboratories, Inc.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:234175-M)
00019221	Beavers, J.B.; Brown, R.; Pink, R. (1977) Pinal Report: Acute Oral
LD50—Mallard Duck: Project No. 8-133• (Unpublished study re-
ceived Jun 22, 1978 under IOO-56T; prepared by Wildlife Interna-
tional, Ltd. in cooperation with Washington College, submitted
by Ciba-<3e!gy Corp., Greensboro, N.C.; CDL:234176-C)
00019222	Robinson, D.; Shillam, K.W.G. (1970) Acute Toxicity of Fluometuron
to the Japanese Quail, Ring-Necked Pheasant and Mallard Duck.
(Unpublished study received Jun 22, 1968 under 100-561; prepared
by Huntingdon Research Centre, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CEL: 234176-D)
00022940 Ciba-Geigy Corporation (1971) Flucmeturon, 1,1-Dimethy1-3-(alpha,
alpha,alpha-trifluoro-m-tolyl)urea, Spectrophotometric Resi-
due Assay Method. Method no. CF-R5 dated Nov 5, 1971. (Unpub-
lished study received Apr 17, 1975 under 1624-104; submitted by
Uhited States Borax & Chemical Corp., Los Angeles, Calif.; CDL:
221088-D)
-------
CFFICE CF PESTICIDE PRO©AMS
REGISTRATION STANDARD bibliography
Citations Considered to be Part of the Data Ease Supporting
Registration Under the Standard For Flucmeturon
MRID	Citation
00024180 Vilkas, A.G. (1977) The Acute Tbxicity of Technical Flucmeturon
to the Water Flea, Daphnia magna Straus: UCES Proj. # 11506-
01-07. (Unpublished study received Jun 22, 1978 under 100-561;
prepared by Union Carbide Environmental Services, submitted by
Clba-Geigy Corp., Greensboro, N.C.; CEL:234176-E)
00044017 Helling, C.S. (1971) Pesticide mobility in soils: II. Applications
of soil thin-layer chromatography. Soil Science Society of
America Proceedings 35:737-748. (Also in unpublished submission
received May 5, 1975 under 464-323; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:221997-S)
00068038 Ciba-Geigy Corporation (1979) Reports of Primary Skin Irritation
and Eye Irritation Studies Made To Support the Appropriate
Signal Words, Warnings, and Precautionary Statements for the
Herbicide Formulation Cotoran (R) 80WP. Sunmary of studies
245045-B and 245045-C. (Unpublished study received May 7, 1981
urder 100-549; CDL.-245045-A)
.00068040.Siglin, J.C.; Becci, P.J.; Parent, R.A. (1981) Primary Skin Irrita-
tion in Rabbits (EPA-FIFRA): FEHL Study No. 6817A. (Unpublished
study received May 7, 1981 under 100-549; prepared by Food and
Drug Research Laboratories, Inc., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:245045-C)
05012167 Helling, C.S.; Kauftaan, D.D.; Dieter, C.T. (1971) Algae bloassay
detection of pesticide mobility in soils. Weed Science
19(6):685-690.
GS0049-001 McCann, J. (1977) Static Jar Test: Lanex 80WP [toxicity to]
Rainbow Trout: Sample No. 123420. Unpublished report prepared
by US EPA, Chemical and Biological Investigations Branch, 1 p.
-------
¦ \ I V
^Eiir ire." '¦>
a - .. . / — Uw J /
r>' /ft)

E PA FtE C I5-TR ATION NO.
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET

'RODUCT NAME
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:
I	|1. I will submit data in a timely manner to satisfy the following requirements. If tne 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:
I 12. I have entered into an agreement with one or mors 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
G 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
~ 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
~ 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 (10-82)
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OMB Approval 2070-0057 (expires 5/31/S6)
(To qualify, certify ALL four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
T. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
1 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 t'
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 mad*
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER

However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) aboV
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inforf
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This stateme"'
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATUBE
DATE
EPA Form BS8&6 (10-821
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Appendix HI-1
PRODUCT SPECIFIC DATA REPORT
EPA Registration No.	Guidance Document for	
Date
Registration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
(For EPA Use CHly)
Accession Numbers
Assigned
Citing MRID#
Submit-
ting
Data
(At-
tached)
§158.20
PRODUCT
CHEMISTRY





61-1
Identity of
ingredients




61-2
Statement of
composition




61-3
Discussion of
formation of
ingredients




62-1
Preliminary
analysis




62-2
Certification of
limits




62-3
Analytical methods
for enforcement
limits




63-2
Color




63-3
Physical state




63-4
Odor




63-5
Melting point




63-6
Boiling point




63-t
Density, bulk-
density, or
specific gravity




63-b
Solubility




63-9
Vapor pressure




63-10
Dissociation
constant




63-11
Octanol/water
partition
coefficient




63-12
EH




1
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Chapter 1—Environmental Protection Agency
§162.10 Labeling requirements.
(a) General--(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations in this Part. The contents of a
label must show clearly and prominently the following:
(1)	The name, brand, or trademark under which the product is
sold as prescribed in paragraph (b) of this section?
(ii)	The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph (c) of this
section;
(iii)	The net contents as prescribed in paragraph (d) of this
section?
(iv)	The product registration number as prescribed in paragraph
(e) of this section;
(v)	The producing establishment number as prescribed in para-
graph (f) of this section;
(vi)	An ingredient statement as prescribed in paragraph (g) of
this section;
(vii)	Warning or precautionary statements as prescribed in
paragraph (h) of this section;
(viii)	The directions for use as prescribed in paragraph (i)
of this section; and
(ix)	The use classification(s) as prescribed in paragraph (j)
of this section.
(2)	Prominence and legibility. (i) All words, statements,
graphic representations, designs or other information required 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, state-
ments, 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 customary 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 applied equally to both the English and
other-language versions of the labeling.
(4)	Placement of Label—(i) General. The label shall appeac
on or be securely attached to the immediate container of the
62
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pesticide product. For purposes of this Section, and the mis-
branding provisions of the Act, "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container
through which the label cannot be clearly read, the label must
also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
(ii) Tank cars and other bulk containers—(A) Transportation.
While a pesticide product is in transit, the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
de i ive ry .
(B) Storage. When pesticide products are stored in bulk
containers, whether¦mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, ihcluding
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
va 1 ve.
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to S 162.15, is misbranded if its labeling is
false or misleading in any particular including both pesticidal
and non-pesticidal claims. Examples of statements or representations
in the labeling which constitute misbranding include:
(i)	A false or misleading statement concerning the composition
of the product;
(ii)	A false or misleading statement concerning the effectiveness
of the product as a pesticide or device;
(iii)	A false or misleading statement about the value of the
product for purposes other than as a pesticide or device;
(iv)	A false or misleading comparison with other pesticides or
devices;
(v)	Any statement directly or indirectly implying that the
pesticide or device is recommended or endorsed by any agency of
the Federal Government;
(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 impression to the purchaser;
(viii)	Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
63
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(ix)	Claims as to the safety of the pesticide or its ingredients,
including statements such as "safe," "nonpoisonous," "noninjurious,"
"harmless" or "nontoxic to humans and pets" with or without such
a qualifying phrase as "when used as directed"; and
(x)	Non-numerical and/or comparative statements on the safety
of the product, including but not limited to:
(A)	"Contains all natural ingredients";
(B)	"Among the least toxic chemicals known"
(C)	"Pollution approved"
(6) Final printed labeling. (i) Except as provided in
paragraph (a)(6)(ii) of this section, final printed labeling must
be submitted and accepted prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally accepted by the Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onto glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b)	Name, brand, or trademark. (1) The name, brand, or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(1)	Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to § 162.6(b)(4).
(c)	Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be qualified
by appropriate wording such as'"Packed for ***," "Distributed by
***," or "Sold by ***¦ to show that the name is not that of the
producer.
(d)	Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2)	If the pesticide isy a liquid, the net content statement
shall be in terms of liquid measure at 68®F (20°C) and shall be
expressed in conventional American units of fluid ounces, pints,
quarts, and gallons,
(3)	If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4)	In all cases, net content shall be stated in terms of the
largest suitable units, i.e., "1 pound 10 ounces" rather than
"26 ounces."
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(5)	In addition to the required units specified, net content
may be expressed in metric units.
(6)	Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a si2e and style similar to other print on that
part of the label on which it appears and shall run parallel 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.
(£) Producing establishments registration number. The producing
establishment registration number preceded by the phrase "EPA
Est.", of the final establishment at which the product was produced
may appear in any suitable location on the label or immediate
container. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) Ingredient statement—(1) General. The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term "active
ingredients" and the inert ingredients by the term "inert
ingredients," or the singular forms of these terms when appropriate.
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 contain 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 normally required on the front panel of the label.
If there is an outside container 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 statement 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.
65
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(3)	Names to be used in ingredient statement. The name used
for each ingredient shall be the accepted common name, if there
is one, followed 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 proprietary 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 per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%." If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticicje
formulation shall also appear in the ingredient statement.
(5)	Accuracy of stated percentages. The percentages given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6)	Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements :
(i)	In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement in a prominent position on the label: "Not
for sale or use after [date]."
(ii)	The product must meet all label claims up to the expiration
time indicated on the label.
(7)	Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be 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
requi' ] on the front panel of the labeling and those which may
appea elsewhere. Specific requirements 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 required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
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| Hazard Indicators

Toxicity
cateqorles


1
i t
I Ill
I iv I
Oral U3
50
Up to and
1 nc (u
reversIble
within 7 days;
Irrftatlon
persisting for
7 days
I
| No corneal opacity;
| Irritation
] reversible
j within 7 days
I
I
I
I |
j No Irritation |
I I
I I
! I
I I
i I
i i
j Sk!n effects
Corrosive
Severe Irritation
at 72 hours
I
| Moderate Irritation
| at 72 hours
I
I
i i
| M1Id or siIght |
j Irritation atj
| 72 hours |
1 1
(i) Human hazard signal word.—(A) Toxicity Category I. All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
addition if the product was assigned to Toxicity Category I on
the basis of its oral, inhalation or dermal toxicity (as distinct
from skin and eye local effects) the word "Poison" shall appear
in red on a backgr ""3 of distinctly contrasting color and the
skull and crossboi.es shall appear in immediate proximity to the
word "poison."
(B)	Toxicity Category II. All pesticide products meeting the
criteria of Toxicity Category II shall bear on the front panel
the signal word "Warning."
(C)	Toxicity Category III. All pesticide products meeting the
criteria of Toxicity Category III shall bear on the front panel
the signal word "Caution."
(D)	Toxicity Category IV. All pesticide products meeting the
criteria of Toxicity Category IV shall bear on the front panel
the signal word "Caution."
67
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(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of a label.
(ii) Child hazard warning. Every pesticide product label shall
bear on the front panel the statement "keep out of reach of
children." Only in cases where the livelihood of contact with
children during distribution, marketing, storage or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
(i ii) Statement of practical treatment--(A) Toxicitv
Category I. A statement of practical treatment (first aid or
other) shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permic
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See statement of
practical treatment on back panel" appears on the front panel
near the word "Poison" and the skull and crossbones.
(B) Other toxicity categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(1){iii)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required elsewhere
on the label in accord with paragraph (h)(2) of this section if
they do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked under customary conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front pane
in square inches
Points
Required
signal word,
all capitals
"Keep out
of reach of
Children"
5 and under 	

6
6
Above 5 to 10 	

10
6
Above 10 to 15 	

12
8
Above 15 to 30 	

14
10
Over 30 	

18
12
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(2)	Other required warnings and precautionary statements. The
warnings and precautionary statements as required below shall appear
together on the laDel under the general heading "Precautionary
Statements" and under appropriate subheadings of "Hazard to Humans
and Domestic Animals," "Environmental Hazard" and "Physical or
Chemical Hazard."
(i) Hazard to humans and domestic animals. (A) Where a hazard
exists to humans or domestic animals, precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident, injury
or damage. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(3)	The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
Pracaut lanary statements by Toxicity category
ToxIcIty
category
Oral, Inhal at'on, or dermal toxicity
Skin and eve local atfacts
Fatal (poisonous) If swallowed I Inhaled or
absorbed through sklnl. Oo not breathe
vapor Idustl or spray mlstl. Oo not get
In eyes, on skin, or on c/othlng [Front
pane/ statement of practical treatment
required.].
II . . .I May be fatal If swallowed I Inhaled or
absorbed through the skin], Oo not breathe
vapors (dust or spray mist!. Oo not get In
•yes, on skin, or on clothing. [Appropriate
tlPst aid statements required.!.
Ill . . .] Harmful If swallowed [Inhaled or absorbed
through the skint. Avoid breathing vapors
(dust or spray mlstl. Avoid contact with
skin {eyes or clothing] lApproprlate
first aid statement required.!
IV . . . | [No precautionary statements required.1.
Corrosive, causes eye and skin damage lor
skin Irrftattonl, Oo not get In eyes, on
skin, or on clothing. Wear goggles or face
shield and rubber gloves when handling.
Harmful or fatal If swallowed.
I Appropriate first aid statement required. I
Causes eye [and skin] Irritation. Oo not
get In eyes, on skin, or on clothing.
Harmful If swallowed. (Appropriate first
aid statement required.!.
Avoid contact with skin, eyes or clothing.
In case of contact Immediately flush
eyes or skin with plenty of water. Get
medical attention If Irritation persists.
(No pi ecautlonary statements required.!.
(ii) Environmental hazards. 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
65
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damage. Examples of the hazard statements and the circumstance*
under which they are required follow:
(A)	If a pesticide intended for outdoor use contains an acti^
ingredient with a mammalian acute oral LD50 of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B)	If a pesticide intended for outdoor use contains an acti^
ingredient with a fish acute LC50 of 1 ppm or less, the statemen
"This Pesticide is Toxic to Fish" is required.
(C)	If a pesticide intended for outdoor use contains an acti^'
ingredient with an avian acute oral LD50 of 100 mg/kg or less, 0
a subacute dietary LC50 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 application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate 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 disposal of
wastes."
(iii)' Physical or chemical hazards. Warning statements on thi
flanunability or explosive characteristics of the pesticide are
required as follows:
Flash point
Required te*t
(A) PRESSURIZED CONTAINERS
Flash point at or below 20*F; If there Is a
flashback at any valve opening.
Flash point above 20*F and not over 80*F or If
the fIame extension Is mora than 18 In. long
at a distance of 6 In. from the flame.
All other pressurized containers .......
Extremely flammable. Contents under pressure.
Keep away from fire, sparks, and heated
surfaces. Do not puncture or Incinerate
centalner. Exposure to temperatures above
J30*F nay cause bursting.
Flammable. Contents under pr-«sure. Keep away
from heat, sparks, and op' ' me. Oo not
puncture or Incinerate container. Exposure to
tee*>eratures above 130*F may cause bursting.
Contents under pressure. Oo not use or store
near heat or open flame. Do not puncture or
Incinerate container. Exposure to ten©ere»
tures above 130*F may cause bursting.
 NONPRESSUR1 ZED CONTAINERS
At or below 20*F 				I Extremely flammable. Keep away from fire,
| sparks, and heated surfaces.
Above 20*F and not over 80*F	| Flammable. Keep away from heat and open flame.
Above 80 *F and not over I50*F	.1 Do not use or store near heat or open flame.
7 ^
( U
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(i)	Directions for Use--(l) General requirements--(i) Adequacy
and clarity 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 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.
(ii)	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
accompanies the pesticide provided that:
(A)	If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B)	The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "See directions in
the enclosed circular." and
(C)	The Administrator determines that it is not necessary for
such directions to appear on the label.
(i ii) Exceptions to requirement for direction for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
<1_) The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s) of
products involved.
{2) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its proper use in manufacturing processes;
(_3) The product will not come into the hands of the general
public except after incorporation into finished products; and
(£) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B)	Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
U) 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 effects on man or the
environment; and
(3)	The product is also a drug and regulated under the provisions
of the Federal Food, Drug and Cosmetic Act.
(C)	Detailed directions for use may be omitted from the labeling
of pesticide products which are intended for use only by formulators
in preparing pesticides for sale to the public, provided that:
Q) 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;
71
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(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general 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 directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of § 162.10(j)(2).
(1)	General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use." And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement under the statutory definitions of misbranding.
(2)	Restricted Use Classification. Pesticide products bearing
direction for use(s) classified restricted shall bear statements
of restricted use classification on the front panel as described
below:
(i) Front panel statement of restricted use classification.
(A) 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 § 162.10(h)(1) ( iv) ) , and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted Use
Pesticide" shall appear.
(B) Directly below this statement on the'front panel, a summary
statement of the terms of restriction imposed as a precondition
to registration shall appear. If use is restricted to certified
applicators, the following statement is required: "For retail
sale to and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator's certification." If, however, other
regulatory restrictions are imposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation.
(k) Advertising. [Reserved]
[40 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975; 40 FR
38571, Aug. 21, 1975, as amended at 43 FR 5786, Feb. 9, 1978]
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APPENDIX IV-2
LABELING REQUIREMENTS OP THE FIFRA, AS AMENDED


APPLICABILITY
PLACEMENT ON LABEL

ITEM
LABEL ELEMENT
OP REQUIREMENT
REQUIRED
PREFERRED
COMMENTS
1
Product name
All products
Front panel
Center front
panel

2
Company name
and address
All products
None
Bottom front
panel or end
of label text
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . etc.
3
Net contents
All products
None
Bottom front
panel or end
of label text
May be in.metric units in addition to
U.S. units
H
EPA Reg. No.
All products
None
Front panel
Mist be in similar type size and run
parallel to .other type.
5
EPA Est. No.
All products
None
Front panel,
inmed lately
before or
following
Reg. No.
May appear on the container instead of
the label.
6A
Ingredients
statement
All products
Front panel
Iimied lately
following
product name
Text must run parallel with other text
on the panel.
6B
Pounds/gallon
statement
Liquid products
where dosage
given as lbs
ai/unlt area
Front panel
Directly below
the main
ingredients
statement

7
Front panel
precautionary
statements
All products
Front panel

All front panel precautionary statements
must be grouped together, preferably
blocked.
7A
Keep Out of Reach
of Children
(Child hazard
warning)
All products
Front panel
Above signal
word
Note type size requirements.
7B
Signal word
All products
Front panel
Inmed lately
below child
hazard
warning
Note type size requlranents.
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APPENDIX IV-2 (continued)
TffiM
LABEL ELEMENT
APPLICABILITY
OP REQUIREMENT
PLACEMENT
REQUIRED
ON LABEL
PREFERRED
COMMENTS
?c
Skull & croaa-
bones and word
POISON (In red)
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
Front panel
Both in close
proximity to
signal word

7D
Statement of
practical
treatment
All products
in Categories
I, II, and III
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
for all.

7E
Referral
statement
All products
where pre-
cautionary
labeling
appears on
other than
front panel
Front' panel


«
Side/back panel
precautionary
statements
All products
None
Ibp or side
of back panel
preceding
directions
for use
Must be grouped under the headings in
8A, 8b, and 8C; preferably blocked.
«A
Hazards to
hunans and
domestic
animals
All products
in Categories
I, II, and III
None
Same as above
Nkjst be preceded by appropriate signal
word.
0B
Envlr^ormental
hazards
All products
None
Same as above
Environmental hazards include bee
caution where applicable.
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APPENDIX IV-2 (continued)
HEM
LABEL ELEMENT
APF TOABILITY
OP b -.UIREMEM1
PLACEMENT ON LABEL
COMMENTS
REQUIRED
PREFERRED
8C
fhysical or
chemical
hazards
All pressurized
products, others
with flash
points under
150 °P
None
Same as above

9A
Restricted
block
All restricted
products
Tbp center
of front
panel
Preferably
blocked
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
9C
Misuse
statement
All products
Inmed lately
following-
heading of
directions
for use


10A
Reentry
statement
All
chol inesterase
inhibitors
In the
directions
for use
lamed lately
after misuse
statement

IOC
Storage and
disposal block
All products
In the
directions
for use
Inmed lately
before
specific
directions
for use or
at the end of
directions
for use
Must be set apart and clearly distin-
guishable from from other directions
for use.
10D
Directions
for use
All products
None
None
May be In metric as well as U.S. units
i n
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Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
Required Label Statement
I. Pressurized Containers
A.
Flashpoint at or below
20 °F; or if there is a
flashback at any valve
opening.
B.
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.
ALL OTHER PRESSURIZED
CONTAINERS
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.
Flaiimable. 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.
II. Non-Pressurized Containers
A. Flashpoint at or below
20 °F.
Extremely flanmable. Keep
away fran fire, sparks, arid
heated surfaces.
B.	Flashpoint above 20 °F
and not over 80°F.
C.	Flashpoint ov<;r oG°F
and not over 150°F.
D.	Flashpoint above
150 °F.
Flanmable. Keep away fran
heat and open flame.
Do not use or store near
heat and open flame.
None required.
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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 minimun type size listed below:
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 subs -es or media.
2.	Fhysical 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
opened containers), and measures to minimize exposure
while opening or closing container.
Size of label
front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)	
10 and under .
Above 10 to 15
Above 15 to 30
Over 30. . . .
.6 point
.8 point
10 point
12 point
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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 reprer itatlve at the
nearest EPA Regio'nal Office for gui^
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:
-------
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, jars)
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Non-aerosol products
(bags)
Do not' reuse bag. Discard bag in trash.
Aerosol products
Replace cap and discard containers in
trash. Do not incinerate or puncture.
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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.
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused!., dispose of in the same manner.
Paper and
plastic bags
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Compressed gas
cylinders
Return-empty cylinder for reuse (or
similar wording)
2/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
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Appendix IV-4
(continued)
Pesticides that are hazardous wastes under ^0 CFR 261.33(e) and
when discarded .
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients, (no inerts):
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-AminopyridIne
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chioroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
5-Cyclohexyl-^,6-dinItrophenol
DIeldrIn
0,0-DIethyl S-[2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-DIethyl 0-pyrazInyl phosphorothioate (Zinophos)
Dimethoate
O,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-DInitro-o-cresol and salts
4,6-DinItro-o-eyelohexylphenol
2,4 Dinitrophenol
DInoseb
Endosulfan
Endothall
Endrin
Famphur
Fluo ro ace tarn id e
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octajnethylpyrophosphoramide (OMPA, schradan)
Parathion
-------
Appendix IV-iJ
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued:
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azlde
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
Ami trole
Benzene
BIs(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
A-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine	hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3,^-metheno-2H-cyclobuta[c,d]-pentalen-2-one
(kepone, chlordecone)
1,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
5-3,3-(DIchloroallyl	diisopropylthlocarbamate (diallate, Avadex)
Q-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Preon 12®)
3,5-Dlchloro-N-(1,l-dimethyl-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (DDD)
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
Hexachlorocyclopentadlene
Hexachloroethane
Hydrofluoric acid

-------
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'-Methylenebls (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Ni trophenol
Pentachioroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodlthioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4,5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachioroethylene
2,3,,6-Tetrachlorophenol
Thlram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Preon 11 )
2.4.5-Triehiorophenol
2.4.6-TrIchlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
-------
Appendix IV—4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Inert Ingredients:
Acetone
Acetonltrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodlfluoromethane (Freon 12®)
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Melelc anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1.1.1-Trichio	roethane
1.1.2-Trichloroethane
Trichlorofluoromethane (Freon 11 )
Vinyl chloride
Xylene
85
-------