UnlMdSMM
EnvfctMiimnttl Protection
AgMtcy
Off id of
PMkidM and Toxic
Washington DC 204M
June 1985
v>EPA
Guidance for the Reregistration
of Pesticide Products
Containing Fluchloralin
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GUIDANCE FOR THE REREGISTRATION
OF PESTICIDE PRODUCTS
CONTAINING FLUCHLORALIN
AS THE ACTIVE INGREDIENT
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
June 1985
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TABLE OF CONTENTS
I n t r o du c t i o ri . . .
I. Regulatory Position and Rationale
II. Requirement for Submission of Generic Data
III. Requirement for Submission of Product—Specific
Data
IV. Submission of Revised Labeling
A. Label Contents . . . . . . .
B. Collateral Information Labeling
V. Instructions for Submission
APPENDICES
Guide to Bibliography . . . . . . . . . . . .
Bibliography. . . . . . . . . . . . . . . . .
FIFRA §3(c)(2)(B) Summary Sheet — EPA Form 8580—1
Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8 58 0— 2 . . . . . . . . . . , , . • •
Product Specific Data Report (End—Use Products)
40 CFR 162.10 Labeling Requirements . . . .
Table of Labeling Requirements
Physical/Chemical Hazards Labeling Statement.
Storage and Disposal Instructions . . . . .
• • . . .1
• I I I 4
• . . . 11
• I I 35
• . . . 38
• . . . 38
• . 44
• . I • 45
h—i
11—2
11—3
11—4
111—1
IV-l
IV-2
IV- 3
IV-4
49
51
57
58
59
60
71
74
75
1
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA sec. 3(g)) directs EPA to reregister all pesticides as
expeditiously as possible.
To carry out this task, EPA has established the Regis-
tration Standards proararn, which will review all pesticide
products containing 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 riot 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 limitations,
or other requirements to assure that proper use of the pesticide
will not result in adverse effects on the environment.
The scientific review, which is not contained in this
Guidance Package but is available upon request, concentrates
on the technical grade of the active ingredient and identifies
missing generic data. However, during the review of these
data we are also looking for potential hazards that may be
associated with the end use (formulated) products that contain
the active ingredient. If we have serious concerns, we will
address end use products as part of the Registration Standards
program and will propose regulatory actions to the extent neces-
sary to protect the public.
EPA has the authority under FIFRA sec. 3(c)(2)(B) to
require registrants to submit data that will answer our
questions regarding the hazard that may result from the
intended use of a pesticide. Although sec. 3(c)(2)(B) provides
that all registrants are responsible for these data, the
Agency generally imposes generic data requirements only on the
registrants of the manufacturing use products (basic suppliers
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of the active ingredient) and other producers who do not
qualify for the formulator’s exemption.*
A producer who wishes to qualify for the formulator’s
exemption may change his source of supply to a registered
source, provided the source does not share ownership in
common with the registrant’s 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 Manager within 90
days of receipt of this Guidance Document. The chart on the
following page shows what is generally required of those who
do and do not qualify for the formulator’s exemption in the
Registration Standards program.
If you decide to request the Agency to cancel the regis-
tration of any of your products subject to the requirements
of this Guidance Document, please notify the Product Manager
named in the cover letter, within 90 days from tne receipt
of this document. If you decide to maintain your product
registration(s), you must provide the information described in
the following pages within the timeframes outlined. EPA will
issue a notice of intent to cancel or suspend the registration
of any currently registered product which does not comply
with the requirements set forth in this Guidance Document.
You are reminded that FIFRA sec. 6(a)(2) requires you to
submit factual information raising concerns of possible
unreasonable adverse effects of a pesticide. You should
notify the Agency of interim results of studies in progress
if those results show possible adverse effects.
*The formulator s exemption applies to a registrant of an
product if the source of his active ingredient(s): (1) is a
registered product and (2) is purchased from a source which
does not have ownership in common with the registrant’s
f i rrn.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
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 reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration 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 be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing use product(s). Such end use products
will be subject to the labeling changes required for products in “II”
above. If there are no manufacturing use products registered by any
company end use products will be required to be reregistered.
NOTE: If all registrants in “I” above fail to meet the requirements in
I—A and B above, then the registrants in “It” 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 Chapter describes the regulatory position and rationale for all
manufacturing—use products (MPs) containing the herbicide fluchioralin
as the sole active ingredient. The Agency bases its position and
rationale on an evaluation of all such products and section 3, 24(c)
and intrastate uses registered for fluchioraliri. End—use products
are reviewed only when there are rip tiPs registered or a label is
changed significantly; mixtures are included only when there is a
significant label change. After briefly describing the chemical and
its uses, this chapter presents the regulatory position and rationale,
the criteria for registration, acceptable ranges and limits, labeling
considerations arid tolerance reassessment.
S. Use Profile
Fluchioralin is a selective herbicide registered for use in controlling
grassy and broadleaf weeds in dry and succulent peas and beans (lima,
navy, kidney, lentils, field, green, pinto, Great Northern, edible
soybeans, field peas, blackeyed peas, cowpeas, and garden peas),
cotton, okra, peanuts, soybeans, arid sunflowers. The most common
use is on soybeans, which represents approximately 85 percent of the
total annual domestic usage. Cotton accounts for most of the rest of
the usage. The only technical fluchioralin product is a 55 percent
liquid concentrate. The only fluchioralin formulation currently on
the market is a 4 lbs ai per gallon emulsifiable concentrate. There
are no registered multiple active fluchioralin products to date, but
two tank mixes (with metribuzin and EPTC) are registered. There are
currently no intrastate registrations or Section 18 registrations,
but there is one 24(c) action which allows the aerial use of Basaliri
on cotton in Arizona.
Fluchioralin is applied in a broadcast manner or a banded spray, using
ground equipment, a few days prior to, or on the day of planting.
Aerial application is not permitted on the federally registered
Basalin label. The herbicide is usually incorporated into the soil
immediately after application. Only one application is allowed per
year.
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C. Background and Description of the Chemical
Fluchloralin is the common name for the herbicide
(N—(2—chloroethy l)—2,6—dinitro—N—prOpyl—4—(trifluOrOmethyl)aflilirle]
which is registered under the trade name Basalin®. The Chemical
Abstracts Service (CAS) number is 33245—39—5 and the EPA chemical
code number (also known as the Shaughrtessy number) is 108701. The
EPA registration number is 7969—46. Fluchioralin was first registered
in 1970 by the B.A.S.F. Wyandotte Corporation, which is currently
the sole manufacturer and formulator.
Technical fluchloralin is an orange—yellow crystalline solid with
a faint, unusual odor and a melting point of 42—43°C. At 20°C,
fluchloralin is highly soluble (>100 g/l00 g) in ethyl acetate,
benzene, ether, acetone, and chloroform, and moderately soluble in
cyclohexane (25.1 g/100 g) and ethanol (17.7 g/l00 g). The solubility
of fluchloralin in water is low (<7 mg/100 g). The vapor pressure of
fluchioralin is 6 x 10—6 mm Hg at 20°C, 2.5 x i0 mm Hg at 30°C.
The empirical formula ts C 12 H 13 ClF 3 3 O 4 , the molecular weight 355.7.
Fluchloralin is sensitive to ultraviolet light, but stable in aqueous
solutions over a range of pH from 5 to 9.
D. Regulatory Position and Rationale
Based on a review and evaluation of all available data and other
relevant information on fluchioralin, the Agency has made the following
determinations:
1. Manufacturing—use pesticide products containing fluchioralin as the
sole active ingredient may be registered for sale, distribution,
and use, subject to the terms and conditions specified in this
Standard. Registrants must provide or agree to develop and provide
additional data, as specified in Tables A and B, in order to maintain
existing registrations or to permit new fluchloralin registrations.
Rationale : Under the FIFRA, the Agency cannot cancel or withhold
registration simply because data are missing or inadequate (see
sections 3(c)(2)(B) and 3(c)(7) of the FIFR.A). Rather, issuance of
this Standard provides a mechanism for inderitifying 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
registrations of fluchioralin.
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2. The Agency will hold such special data requirements as groundwater
monitoring in reserve pending receipt and analysis of the animal
metabolism studies and leaching studies required under the Standard.
Rationale : Although the parent compound does not leach through soil,
a degradate of fluchioralin (2,6_dlnitro_4_trifluoromethylpheflol —
BAS—392—D—4) is highly mobile in Limburgerhof loamy sand soil and
mobile in Bruchfeld sandy clay loam soil. By itself, this mobility
is insufficient to give rise to special data requirmentS, but if
leaching studies indicate potential for exposure, and the animal
metabolism studeis indicate that the degradate may b e of toxicological
concern, then further data requirements may be imposed.
3. Tolerances for significant new food uses will not be granted until
the requested toxicological data have been received and reviewed.
Rationale : There is cause for concern because there is an almost
complete lack of valid toxicological data, and Eluchloralin is
structurally similar to trifluralin. The Agency has received data
which indicate trifluralin causes cancer in animals. Therefore,
registration of significant new food uses could cause oncogenic or
other hazards which cannot be evaluated without the requested
toxicological data.
4. Pending the submission and review of rotational crop data, registrants
will be required to place a statement on the labels of fluchioralin
end—use products, prohibiting planting of crops (other than those for
which fluchloralirt is registered) for a 12—month period after the
last use.
Rationale : Until more is known about the plant metabolism and
environmental fate of fluchioralin, the Agency cannot determine
whether crops planted in fluchioralin—treated fields will contain
fluchloralin residues. If there are such residues, they could add
to the overall dietary exposure.
5. The required Product Chemistry data on contaminants will be reviewed
closely to determine the presence and extent of nitrosamine
contamination. If contamination exists, and is of a type and at a
level high enough to be of toxicological concern, then other data
may be required, as appropriate.
Rationale : Close review of contamination dat _ appropriate because
nitrosamine contamination is known to occur in the technical compound.
At present there is rio evidence of contamination at levels of concern,
and therefore no other regulatory action is called for at this time.
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6. The Agency has identified a concern for endangered species from use
of fluchioralin on soybeans. This concern is supported by a jeopardy
opinion from the U.S. Fish and wildlife Service. Protection of
endangered species will require a modification of the existing end—use
product labels. Specific label language and methods for protecting
endangered species are currently being completed, and the Agency will
implement some form of label restriction prior to the 1986 growing
season.
Rationale : Appropriate labeling for the protection of species
determined to be in jeopardy is being developed in conjunction with
a generic (cluster) approach, rather than under this Standard. This
generic approach, which entails the analysis of the effects of all
pesticides on endangered species on a crop by crop basis, rather
than a chemical by chemical approach, is being developed in
cooperation with Federal and State enforcement agencies, the Office
of Endangered Species (OES), the U.S. Department of Agriculture (USDA),
the National Agricultural Chemical Association (NACA) and both the
state and county extension services. Thus, the labeling developed
under this approach will encompass all endangered species associated
with use of pesticides on that particular crop.
7. No additional label requirements pertaining to toxicity or hazard to
humans (i.e. protective clothing, precautionary statements, etc.)
will be imposed until the toxicological data have been submitted and
reviewed. Statements currently on the label will be maintained.
As noted in Section G, registrants will be required to place certain
statements pertaining to toxicity to fish on labels.
Rationale : There are virtually no valid toxicological data for
fluchioralin, and hence no indication of potential hazards to humans.
Witbout an indication of what hazards would be mitigated, it would be
inappropriate to require new precautions to be added to product
labels. The current label statements will be presumed appropriate,
in the absence of data to the contrary. Valid data on the toxicity
of fluchioralirt to fish are available, and indicate the necessity of
an additional statement.
E. Criteria for Registration Under This Standard
To be covered by this Standard, products must:
o be a manufacturing use product containing fluchioralin as the
sole active ingredient,
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o bear required labeling and conform to the product composition,
acute toxicity limits, and use pattern requirements listed in
Section F of this document.
The applicant for registration or reregistration of products subject
to this Standard must comply with all terms arid 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.
F. Acceptable Ranges and Limits
1. Product Composition Standard
Technical grade products must contain t least 55 percent fluchioralin
as the sole active ingredient. Each manufacturing—use product
formulation proposed for registration must be fully described with an
appropriate certification of limits. In addition, the active ingredient
found in the manufacturing—use fluchioraliri products must be
substantially similar to that in currently registered technical
products. Any manufacturing—use product 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,
manufacturing—use products, and end—use products containing fluchloralin
when the product is supported by acute toxicity data and the labeling
of the product bears the appropriate precautionary statements.
3. Use Patterns
To be registered under this Standard, manufacturing—use products
containing fluchioralin must be labeled for formulation into end—use
products that are to be used only for the control of grassy and/or
broadleaf weeds in beans or peas (kidney, lima, navy, lentils, field,
green, pinto, Great Northern, edible soybeans, blackeyed peas, cowpeas,
field peas and garden peas), cotton, okra, peanuts, soybeans, or
s u nfl owe r s.
G. Required Labeling
All technical grade and manufacturing—use products containing
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fluchloralin must bear appropriate labeling as specified in 40 CFR
162.10. Other portions of the guidance package contain specific
information regarding label requirements. In addition, the following
specific labeling requirements apply to technical and manufacturing—use
products:
1. Use Pattern Statements
“For formulation into end—use herbicide products intended only for
use on kidney, lima, navy, green, pinto, Great Northern or edible soy
beans, blackeyed, cow, field or garden peas, cotton, okra, peanuts,
or sunflowers.”
2. Precautionary Statements
Environmental Hazard Statement
‘This pesticide is toxic to fish. Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries, oceans, or public
waters unless this product is specifically identified and addressed
in a MPDES permit. Do not discharge effluent containing this product
to sewer systems without notifying the sewage treatment plant authority.
For guidance contact your State Water Board or Regional Office of the
EPA .“
The following specific labeling requirements apply to the end—use
products:
“This pesticide is toxic to fish. Do not apply directly to water.
Drift and/or runoff from treated areas may be hazardous to fish in
adjacent aquatic sites. Do not contaminate water by cleaning of
equipment or disposal of wastes.”
“Do not plant food and feed crops in fluchloralin—treated fields for
a period of at least 12 months after the last application of
fluchioralin, unless fluchioralin is authorized for use on those crops.”
The labels of all products must bear the appropriate container disposal
statement. See Appendix IV—5 of this guidance package.
The required statements listed in this Standard must appear on the
labels of all MPs and EPs released for shipment after July 1, 1986.
The labels of all MPs and EPs currently in the channels of trade must
be modified to include all the listed statements by July 1, 1987.
After review of data to be submitted under this Standard, the Agency
may impose additional label requirements.
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H. Tolerance Reassessment
Fluchioralin is currently registered for use on cottonseed, soybeans,
seed and pod vegetables, sunflowers, and peanuts. The PADI is 0.0026
mg/kg/day, based on a 90—day feeding study (dogs) NOEL of 5.250
mg/kg,’day (210 ppm), LEL = 15.75 mg/kg/day (hemisiderosis in the
liver) and using a safety factor of 2000. The portion of the PADI
currently occupied is 2.44, or <3%.
The feeding study on which the PADI was based has been declared
invalid. Therefore, the currently established PADI for fluchioralin
is not supported by the toxicology data base. However, the
portion of the PADI occupied is <3%.
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II. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA sec. 3(c)(2)(B). The
tables following this section list the data required for
maintaining the registrability of each product.
EPA has determined that additional generic data described
in Table A must be submitted to EPA for evaluation in order
to maintain in effect the registration(s) of your product(s)
identified as art 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 DataJ L 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 Y 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 delete 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
1/ 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).
V The Pesticide Assessment Guidelines are available in hard
copy or microfiche from the National Technical Infermation
Service, 5285 Port Royal Road, Springfield, Va. 22161.
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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 “typical formulations” but
not others. Note : “Typical formulation” data should not be
confused with product—specific data (Table B) which are
required on each formulation. Product—specific data are
further explained in Chapter III of this document.
C. Options Available for Complying With 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.
OR
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)*/
*/ 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 terms 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 riot 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 opirilOn, 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 large 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 boria 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)J;
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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TP 1 BLE A
GENERIC EWFA RBAJIREMENTh [ OR FLUQIWRALIN (97% UNRWISTERED TEQ-INICAL)!/
_____________________________________________— L ta Must Be
Giideline Citation and Test (utidelines Are [ ata Footnote Submitted Within
Name of Test Substance Status Rajuired Number Time Frames Listed
Yes No Below . L
§158.120 Product Chemistry
Product Identity :
61—2 — r scription of Beginning Materials TGAI R I ii ____________ 6 t4Jnths
and Manufacturing Process
61—3 — Disa ission of Fornation of TCM R ( I 1) _____________ 6 Wnths
Inpur ities
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis TGAI CR IXI (1 ____________ 12 t tnths
Physical and Ch nical Characteristics
63-2 - Color TGAI R (I IX ] ____________
63—3 — Physical State TGAI R fl lxi ____________
63—4 — Odor TGAI R [ I IX ) _____________
63—5 — Malting Point lGk [ R (I IX ) _____________
63—6 — Boiling Point ¶ftAL / R I i (Xi ____________
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TABLE A
GE ER1C Ei TA R tJIR M NI’S LOR FLLJUILORALIN (97% UNRWIS’F RE D TEcHNICAL)V
Deta must Be
Qiideline Citation and Test Qiidelines Are Data Footnote Submitted Within
Name of Test Substance Status Required Number Time Frames Listed
Yes No Below /_______
§158.120 Product Chemistry (Continued)
Physical and Ch nical Characteristics
(Continued)
63-7 - Density, Bulk Density, or TGAI R (X I (1 __________ 6 rtnths
Specific Gravity
63—8 - Solubility TGAI or PAl R Ii lxi ___________
63-9 - Vapor Pressure PAT R [ I lxi ___________
6 3—10 — Dissociation constant PAT R (X I Ii ___________ 6 k)nths
63—11 — Octanol/ ater partition PAl R (XI Ii ___________ 6 t4nths
coefficient
6 3—12 — pH TGAI R (XI Ii ___________ 6 t’ nths
63—13 — Stability ‘IXAI R IX ) Ii ___________ 6 F bnths
Other Requirc5nents :
64— 1 — Submittal of samples ¶I AI, PAT CR (I (XI ____________
. •....I S ••e•S .S•S•••ISS••S••IS•••
TGAI = Technical Grade of the Active Ingredient; PAl = Pure Active Ingredient; R = Required; CR = Conditionally Required
/ The 97% technical is not a registered manufacturing—use product.
2/ Data nust be submitted within the indicated time frame, based on the date of the (Iiidance L)cument.
o 6 Month Due Date is January 1, 1986 .
o 12 f&nth Due Date is July 1, 1986
Data are not required because the 97% technical is a solid at root t perature.
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TABLE A
GENERIC DATA RF) IJIREMENTS FOR I!LUQILORALIN
L ta Raluireim nts
Cc upositioni/
Ebes EPA Have l ta
To Satisfy This
Ra 1uiren nt? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional [ ta
Be Submitted Under
FIFRA S 3(c)(2)(b)?
Tine Franes for
Data Sutinission . 4L
§158.125 Residue chemistry
171—4 — Nature of Residue (Metabolian)
— Plants
PAIRA
Partially
00052467
00106529
00106530
GS0189—0l
00106531
00106532
00106540
24 Months
171—4 — Residue Analytical Method
00036657
00036665
00036673
00047773
00047905
00047907
00055010
00055011
00055012
00085056
00085058
00106501
00106534
00106540
00106543
GSO 189—02
GSO 189-03
GSO 189—04
- Livestock
— Plant residues
PAIRA and Plant
Me tabol i tes
TGAI and Metabolites
Yes
Yes
00052469
00052479
GSO 189—01
No
No /
— Min l Residues
TGAI and Metabo1it s No
-------
TABLE A
GENERIC DATA RfX UIREMFNFS I OR L’LUQIWRALlN
Data Re uireirents
Cciipositiord/
es EPA Have Data
To Satisfy This
REquirem nt? (Yes,
No, or Partially)
Bibliographic
Citation
Must ldditional Data
Be Submitted Under
FIFRA § 3(c)(2)(b)?
Time Frames for
Data Sutinission /
§158.125 Residue Chemistry (continued)
171—4 — Storage Stability Data PAl
171—4 - Magnituie of the Residue—
Residue Stuiies for Each
Food Use
— Crcp Grcup #1 — (Legume Vegetables Grcup)
o Crcp 1 (Dry Beans)
—- Crcp field trials TEP
o Crop 2 (Lentils)
-- CrqD field trials TEP
o Crop 3 (Lima Beans)
-- Crcp field trials TEP
o Crcp 4 (Peas — dried and succulent)
TEP
Yes 00055013
00106534
00085055 Nc /
00085056
Yes 00085055
00085056
00085055 No?/
00085056
00085055 No1/
00085056
Yes
Yes
Yes
—— Crop field trials
-------
TABLE A
GENERIC IY TA REO(JIREMFNI’S FOR FLUCHWRALIN
Lbes EPA Uave Data
To Satisfy This
Ra uirenent? (Yes,
No or Partially)
Must Additional Data
Be Submitted Under
I?IFRA § 3(c)(2)(b)?
Tine Frames for
Data Subnission L
o Crop 5 (Snap Beans)
- Crop Grcup 2 (Ftliage of Legume Vegetables Gronp)
o Crop 1 (Bean vines and hay)
—- Crop field trials TEP
o Crop 2 (Lentil forage and hay)
00085055
00085056
00047773
00104436
00106534
00085055 No
00085056
00085055 No
00085056
Data Requirement
cctnpositiord!
§158.125 Residue Chemistryl (cor tinued)
171—4 — Magnitude of the Residue—
Residue Studies (cont .nued)
- Crop Grwp 1 (Legume Vegetable Grcup) (continued)
Bibliographic
Citation
—— Crop
field trials
TEP
Yes
o
Crop 6
(Soybeans)
—- Crop
field trials
TEP
Yes
Yes
TEP
Yes
No2/
No
- — Crop field trials
-------
TABLE A
GENERIC [ Y TA RF.X IJIREMENTS FOR L(JC11WKALIN
Eata Re uireni nt Cc ipositionh/
§158.125 Residue Chemistry (continued)
171—4 - Magnitude of the Residue—
Residue Studies (continued)
- Crcp Grcup 2 (Foliage of Legune
o Crcp 3 (Paa vines and straw)
-- Crcp field trials TEP
- Crcp Graip 3 (Hert and 4ices)
—— Dill — crcp field trials TEP
Miscellanecils Ccinnodities
- - Cottonseed - crcp field TEP
trials
00106501
00106543
00085057
00085058
Ekes EPA Have [ ta
To Satisfy This
Re uirenent? (Yes,
Nb or Partially)
Bibliographic
Citation
Vegetables Grcup) (continued)
Yes
Must Additional Eata
Be Submitted Under
FIFRA § 3(c)(2)(b)?
Tine Frames for
Eata Subiussion L
Yes .I 15 Months
No
Yes / 15 Nbnths
No
No
No /
00085055 NoW
00036657
00106534
00106540
No
Yes
No
Yes
Yes
N/A
Okra — crcp field trials TEP
—— Peanits — crcp field TEP
trilas
-- Sunf1o r seeds - crcp TEP
field trials
-- Maat/milk/poultry/eggs TGAI or plant
netabol ites
-------
GENERIC IY TA RI O(JIREMENTS L OR FLUQI [ ORALIN
§158.125 Residue Ch nistry
(continued)
/ Ccuposition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP =
Typical end—use product; EP = End—use product.
2/ Data must be submitted within the indicated time frame, based on the date of the Guidance Doaiment.
o 15 nonth due date is October 1, 1986 .
o 24 im nth due date is July 1, 1987 .
/ Data are required to reflect the distrll*ition and natabo1i n of ring-labeled ‘ 4 C—fluchloralin in nature soybeans
(beans) and nature cottonseed fran plants gr n in soil treated at 2 lb al/A. Exaggerated rates nay be rejuired to
obtain sufficient residues for identification.
/ If the data rejuested under §158.125 — 171—4 (Nature of Residue in Plants) indicate additional metabolites of
toxicological concern, the submission of additional validated netbods for data collection and tolerance enforc nt
will be r uired.
5/ Data are not re uired because metaboli n data shows that residue levels of fluchoralin in animal tlssu result-
ing fran registered uses would be below the detection limit for determining fluchoralin residues.
6/ If the data reauest4 under §158.125 — 171—4 (Nature of Residue in Plants) indicate additional metabolites of
toxicological concern, u$ submission of additional data depicting the storage stability of these metabolites will
be reguired.
/ Establish nt of thiè crop group tolerance is dependent upon the estab1ist nent of a crop group tolerance for foliage
of legume vegetables, because one cannot be established without the other. To establish a crop group tolerance for
foliage of legume vegetables, the registrants must submit residue data ftcin pea straw and the forage, hay, and straw
of soybeans.
8/ To establish a crop group tolerance for the foliage of legume vegetables group, the registrant must submit residue
data fran pea straw and the forage, hay, and straw of soybeans. Since feeding restrictions presently exist for the
foliage of soybeans, the registrant nay elect to propose a crop group tolerance for the foliage of legume vegetables
except soybeans and submit only the reguired data for pea straw.
9/ If a registrant wishes to register a use for fluchloralin on dill, residue data for the justification of an
appropriate tolerance for residues of fluchloralin on dill nust be submitted.
4 / If the petitioner wishes to retain the registered pre-plant—incorporation use for okra, a tolerance for residues in
or on okra mist be proposed, for whid residue data f ran nature okra harvested fran plants grown in coarse soil
pre—plant treated at 1.0 lb al/A, medium soil treated at 1.25 lb al/A, and fine soil treated at 1.5 lb ai/A
will be reguired. These studies should be conducted in Texas and Georgia, because these states represent 25 and
20%, respectively, of the total U.S. ccrnmercial okra production area.
11/ The available data support a Category 3 Isee 40 CFR 180.6(a)J classification for residues of fluchloralin in meat,
milk, poulti.:y, and eggs. No tolerances are reguired, because the available data indicate that ingestion of teed
it bearing up to lox the naximum permissible residues of tluchloralin should not produce finite residues in
-------
TABLE A
GENERIC DATA RIEO(JIREMENTS OR FL(JO-IWRALIN
00052468
00106538—D
Must Mditional Data
Be Submitted Under
FIFRA §3(c)(2)(B)?
Time Frames for
Data Subi ission L
Data Requir nent
Cci os it ion!I
Use
Patterr /
D.Des EPA Have Data
To Satisfy This
Ra uireuent? (Yes,
No or Partially)
bibliographic
Citation
I AI or PAIRA
§158.130 Enviror.mental Fate
DEGRAD1 TION STtJDIES-LAB:
161—1 — Hydrolysis
Photodegradat ion
161—2 — In water
161—3 — c soil
161—4 — In Air
METABOLISM ST(JDI ES-LAB:
162-1 — Aerobic Soil
TGAI
TGAI
TGM
or PAIRA
or PAIRA
or PAIRA
A,B No
A,B Yes
A,13 No
A,B No
A,B Yes
00106520
T AI or PAIRA
162—2
162—3
162—4
— Anaerobic Soil
— Anaerobic A uatic
— Aerobic Pquatic
TGAI
TGAI
or PAIRA
or PAIRA
or PAIRA
Yes 9 Months
No
Yes 9 t bnths
NQ /
No
Yes 27 Wnths
NQ /
NQ /
AB
A,B
A, B
No
No
No
-------
TABLE A
GENERIC tY TA RBJJIREMEZ’1IS fOR FLUQIWRALIN
Ccnbination and
Tank Mixes
164—5 — Soil, Long—term
Yes 12 Months
NQ /
No /
Data Re 4uiranent
Canpos ition /
Use
Pattern /
Ekes EPA Have Data
To Satisfy This
Rajuirenent? (Yes,
No or Partially)
Bibliographic
Ci tat ion
Must 1 dditional I ta
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frames for
Suhaitting Data L
§158.130 Environmental Fate
(continued)
MOBILITY STUDIES:
163—1 — Leaching and
Ac orption/E soi:pt ion
163—2 — Volatility (Lab)
163—3 — Vblatility (Field)
DISSIPATION S JDIES-FIELD:
164—1 — Soil
164—2 — kjuatic (Sediment)
164—3 — Forestry
164—4
A,B No
rGAI or PAIRA
TEP
TEP
TEP
TEP
TEP
A,B
A,B
A,B
A, B
A,B
A,B
No
No
No
No
No
No
Yes 27 Months
No /
No
TEP A,B No
No2/ 50 Months
-------
TABLE A
G ERIC LWFA RE1 UIREM1 1TS WR FLUOJIJDRALIN
Data R& uiranent
Use
Cat ositionV Pattern /
DDes EPA Uave Data
To Satisfy This
Re1uire tent7 (Yes,
No or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frames tor
Sutmitting Data. L
S158.130 Environmental Fate
ACCUMULATION STUDIES :
165-1 - Rotational Crcps
(Confined)
165-2 - Rotational Cr s
(Field)
— Irrigated Crcps
— In Fish
- In Aquatic Non—Target
Organ isn
§158.140 Reentry Protection
165—3
165—4
165—5
PAIRA A,B
TEP
TEP
No
No
No
No
No
TGAI or PAIRA
A,B
A, B
A, B
Yes 39 Months
Yes 50 Months
NQ /
Yes 12 Months
TEP A,B No
NQ /
-------
TABLE A
GENERIC [ W TA RE1 JIREMFNIS FOR FLUCHWRALIN
§158.130 Enviror nental Fate
(continued)
1/ Ccrrposition: TGM = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
/ The use patterns are coded as foll s; A = Terrestrial, Food Crcrp; B = Terrestrial, Nor —Food; C = Pijuatic, Food
Crcp; D = Aluatic, Non—Food; E = Greenhouse, Food Crq; F = Greenhouse, Non—Food; G = Forestry; H = Dcu stic
Outdoor; I = Indoor
3/ Data must be submitted within the indicated time—frame, based on the date of the Guidance Document.
o 9 ttnth Due Date is March 1, 1986 .
o 12 Month Due Date is July 1, 1986 .
o 27 r4nth Due Date is October 1, 1987 .
o 39 Month Due Date is October 1, 1988
o so Nonth Due Date is September 1, 1989 .
4/ No data are rejuired because vapor pressure data indicate that the terrestrial uses are unlikely to have air
inpact s.
No data are r uired because there are ito aquatic uses, forestry uses, or uses likely to have aquatic inpacts.
6/ No data are re uired because the use pattern, vapor pressure, and toxicity data indicate minimel hazard through
inhalation.
2/ Data are not required because the valid aerobic soil iietaboli n studies den nstraLe that >50% of the residues
dissipate prior to recanrrended suts uent application.
/ The practice of soil incorporation is expected to minimize exposure during reentry operations.
-------
TABLE A
GENERIC LY TA RI Z)UIREME1fl’S OR FLUC%IEURALIN
Data RequirQ ent
§158.135 Toxicology
ACUTE TESTING :
81-1 — Oral
81—2 —
81—3 —
81—4 —
81—5 — Prin ry Dern al Irritation
81—6 — Dexm l Sensitization
81-7 — Acute Dalayed
Neurotoxicity — lien
SUBCH} JNIC TESTING :
82—1 — 90—Day Feeding —
Rodent,
Non—rodent
21—Day DenTal
90—Day Dermal
1 I A,B
TGAI A,B
•miu A,B
TGM AB
No
No
No
No
9 Months
9 Monhhs
9 Months
Use
Caiços it ionL Pa tterns /
Ebes EPA Have Data
To Satisfy This
R uir nt? (Yes,
No or Partially)
Bibliographic
Citation
Must Psiditional Data
Be Submitted Under
FIFRA S3(c)(2)(B)?
Time Frames for
Subuitting Data2
,I I
1 3AI
De ml
Inhalation — Rat
Priirary Eye Irritation -
Rabbit
A,B
A, B
A, B
No
No
No
9 Months
9 Months
9 Months
Yes
Yes
Yes
Yes
Yes
Yes
No 4
82—2 —
82—3 —
1X AI
A,B
No
NoW
TGAI
A,B
No
NOW
TGAI
A,B
No
Yes
12
Months
TGAI
A,B
No
NoW
-------
TABLE A
GENERIC IYi TA RFX (JIREMENTS FOR FLUCHLORALIN
Data Requiranent
Use
Cczipositioni/ atternsa/
Does EPA Have Data
To Satisfy This
Raluirenent? (Yes,
No or Partially)
Bibliographic
Citation
ttist Mditional Data
13e Submitted Under
FIFRA §3(c)(2)(B)?
Time Frames tor
Sutinitting Data. L
§158.135 Toxicology
82—4 — 90—Day Inhalation:
— Rat
82—5 — 90-Day Neurotoxicity:
— Hen
—Mainna 1
§158.135 Toxicology — Continued
CHRJNIC TESTING :
83-1 — Chronic Toxicity —
2 species:
— Rodent, and
— Non—rodent (r Dg)
83-2 — Oncogenicity — TGAI
2 species:
— Rat (preferred), and
- Mciise (preferred)
83-3 — Teratogenicity — TGM
2 species:
— Rat
- Rabbit
83—4 — Reproduction — Rat
2—generation
A,B
TGAI A,B
TG kI
N/A
N/A
A,B
No
No
A, B
No
No
No
No
A,B No
Yes 50 Months
Yes 50 £ bnths
Yes 50 Months
Yes 50 f tnths
Yes 15 Months
Yes 15 Nonths
Yes 39 Months
-------
TABLE A
GENERIC DATA R O(JIREMENIS FOR FLUCIILORALIN
DDes EPA Have
Data To Satisey
This Require-
ment? (Yes, No
or Partially)
Must Mditional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame tor Data
Sutxniss ion L .
Data R uir nt
1/
CclTpos it ion
Use 2/
Pattern
Bibliographic
Citation
§158.135 Toxicology — ( ntinued
MUTACENICITY TESTING
84—2 — Gene Mutation (Ames Test)
84—2 — Structural thra saral
Aberral ion
84—4 — Other Genotoxic Effects
SPECIAL TESTING
85—1 General Metabolian
T( AI
A,B
No
Yes
9
Months
TGAI
A,B
No
Yes
12
Months
A,B
No
Yes
12
Months
A,B No
Yes 24 Months
-------
TABLE A
GENERIC DATA RB UIREMENTh FOR FLUQIWRALIN
§ 158.135 Toxicology — Continued
1/ Ca osition: 1 AI = Technical Grade Active Ingredient; PA! = Pure Active Ingredient; PAIRA = Pure Active Ingredient,
Radiolabeled
/ The use patterns are coded as follc s: A = Terrestrial, Food Crcp; B = Terrestrial, Non—Food; C = 1 quatic, Food Crop;
D = A uatic, Non—Food; E = Greenhc*ise, Non-Food; G = Forestry; H = IXxi stic CXitdoor; I = Indoor.
/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
o 9 Nor th Doe Date is March 1, 1986 .
o 12 Month Due Date is July 1, 1986 .
o 15 Nonth Doe Date is October 1, 1986 .
o 24 Month Doe Date is July 1, 1987 .
o 39 Wnth Doe Date is October 1, 1988 .
o so Month Doe Date is Septanber 1, 1989 .
Data are re uired only for or ncphosphates or their in tabolites.
5/ No data are r uired because chronic toxicity data are being re uired.
6/ No data are reuired because use does not involve purposeful exposure to the skin.
No data are r uired because use does not result in repeated inhalation.
Data are rejuired only for organcphospphates or their metabolits that display delayed neurotoxicity in acute testing.
-------
§158.145 Wildlife and
Aquatic Organi s
AVIAN AND MAMMALIAN TESTING
71—1 — Acute Avian Oral Toxicity
71-2 - Avian Subacute Dietary
Toxicity
— Upland Game Bird, dnd
— terfow1
71—3 — Wild Mamnal Toxicity
71-4 — Avian Reproduction
— Upland Game Bird, and
— terfowl
71-5 — Simulated Field Testing
— Marnuals, and
- Birds
O1 3ANISM TESTING
FreslMater Fish Toxicity
— Cold iater Fish Species,
and
— iinwater Fish Species
72—2 — Acute PDxicity to
FrestMa ter Invertebrates
Data R&juira nt
TABLE A
GENERIC DATA RBJJIREMENTS I OR ‘LUCIIWRALIN
Des EPA Have
Data To Satisfy
1/ Use / This Require-
Cciuposition Pattern nent? (Yes, No
or Partially)
Bibliographic
Citation
Must Pilditional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission . /
A,B No
A, B
No
No
A,B No
Yes 9 Months
TGAI
AI
TGAI
AI
T P
TGAI
TGAI
Yes
Yes
Reservect /
9 Months
9 Months
AQUATIC
72—1 —
A,B
A,B
AB
A,B
Partially
00039449
No
Partially
00039450
No
Yes 00039445
Yes 00039445
A,B No
No
No
Yes 9 Months
-------
TABLE A
GENERIC IY TA RhO(JIREMEN1S OR I tUCH [ ORALIN
Data Requir nt
Use
Cciipositionb” Pattern /
L es EPA Have Data
To Satisfy This
Re uire nt? (Yes,
No or Partially)
Bibliographic
Citation
Must Mditional Data
Be Submitted Under
FIFRA §3(c)(2)(B)?
Time Frame for
Data Suhniss ion L
§158.145 Wildlife and lquatic Organisms (continued)
72—3 — A ite Toxicity to Estuarine
and I’1 rine Organisn
a. Shrii p
b. r . rine Fish
c. oyster
72—4 — Fish Early Life
Stage and Ajuatic
Invertebrate Life—Cycle
72—5 — Fish — Life—Cycle
72—6 — Apiatic Organisn
Ac cumu].a t ion
¶L I A,B
TGAI A,B
A,B
TGAI A,B
TG I A,B
TGM, PAl or A,B
Degradation
Proc ict
Partially
No
12 Months
Yes. / 12 Nonths
Yes. / 12 Nonths
72—7 — Simulated or Actual
Field Testing —
kluatic Organi
TEP A,B
Reserved !/
No
No
No
No
Reserved ./
00 1064972/ eservectV
Reserved /
No
-------
TABLE A
GFI4ERIC DATA RBJJIREMENIS OR FLUOIWRALIN
§158.145 Wildlife And 1 quatic Organi s (continued)
/ Ccinposition: ¶LX I = Technical grade of the active ingredient; PAl = Pure active ingredient; TEP = Typical end-use
product.
-2/ The use patterns are coded as fol1 ,s: A = Terrestrial, Food Crcp; 13 = Terrestrial, Non-Food; C = kjuatic, I?ood
Crc ; D = klua tic, Non—Food; E = Greenhwse, Food Crcp; F = Greenhwse, Non-Food; G = Forestry; H = Ek s tic
Outdoor; I = Indoor
3/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
9 Month IXie Date is March 1, 1986 .
° 12 Month IAie Date is July 1, 1986 .
4/ Data may be r u i red, depending on the nature of envi rorE enta 1 data yet to be submi I ted.
5/ Data may be required, depending on the nature of toxicological data yet to be submitted.
6/ Fluchioralin has LC 50 values belc 1 p in for fish. More than 300,000 acres each of cotton and soybeans are grc n
in coastal areas. Therefore, data are required.
-------
TABLE A
GENERIC [ WrA REI UIRFMEN1’S OR LUQILORALIN
Ebes EPA Have Data
To Satisty This
Must Additional
Data Be Submitted
Use
Data Requirar nt CcinpositionV Pattern ./
Ra uireu nt? (Yes,
No, or Partially)
Bibliographic
Citation
Under FIFRA Section
3(c)(2)(B)?. /
§158.155 Nontarget Insect
NONTARGET INSECF TESTING -
Fkilhinators:
141-1 — Honey bee aaite TGM A,B Yes 00106498 No
contact toxicity
141—2 — Honey bee — toxicity of TEP A,B No Na /
residues on foliage
141—3 — Wild bees iirçortant in TEP A,B N/A
alfalfa pollination—
toxicity of residues
on foliage
141-4 — Honey bee subao.ite [ Reserved)W
feeding study
141-5 — Field testing for TEP AB No Na /
pollinators
-------
TABLE A
GENERIC L TA RE JIREME ,flS I OR FLUQIWRALIN
Ibes EPA Have Data
Must Mditional
To Satisfy This
Data Be Submitted
Use
Data Rejuiranent Caiposition / Pattern /
Ra juireii nt? (Yes,
No or Partially)
Bibliographic
Citation
Under FIFRA Section
3(c)(2)(B)? /
§158.155 t4ontarget Insect (continued)
NOt TrAf 3ET INSECT TESTING —
I Q(JATIC INSECTS:
142-1 - Acute toxicity to IReserved 2/
aquatic insects
142-2 — kjuatic insect IReservedli/
1ife—c le study
142—3 — Simulated or actual IReservedl2/
field testing for
aquatic insects
14 3-1— NONTA1 F INSECT TESTING (Reserved]2/
thru PREDA1DRS AND PARASITES
143—3
/ Canpcsltion: TGAI = Technical grade of tthe active ingredient; TEP = Typical end-use product.
/ The use pattern codes are as fo11c is: A = Terrestrial, Food Crcp; B = Terrestrial, Non—Food; C = Aguatic, Food Crop;
D = Pquat i C, Non—Food; E = Greenhouse, Food Crop; F = Greenhouse, Non—Food; G = Forestry; H = Dcu s tic (1 tdoor;
I = Indoor.
3/ Unless otherwise specified, data must be submitted no later than six months after issuance of this Standard .
As data fran the acute contact test indicate low toxicity to bees, no further testing is re uired.
5/ No data are required because fluchioralin is not registered for use on alfalfa.
6/ Reserved pending deuelcVn nt of test n thodo1ogy.
7/ Reserved pending Agency decision as to whether data ra uir nents should be established.
-------
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 111—1) 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 §3(c)(2)(B).”
/ Product specific data pertain to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
—35—
-------
TABLE B
P JDE CT SPECIFIC [ ATA REX)LJIREMENTS FOR MANUFACTURING-USE PE )DUC [ S (X1 !fAIN1NG FLUQILORALIN (55% Fl
L es EPA Have Data
Must Additional
To Satisfy This
Data Be Submitted
R juir nt? (Yes,
Data Re uireuent Canpceition ?./ No or Partially)
Bibliographic
Citation
Under FIFRA Section
3(c)(2)(B)? /
S158.120 Product Chanistry
Product Identity :
61—1 — Identity of Ingredients MP Yes 00036206 No
61—2 — Statement of Cciuposition MP No Yes 6 Nonths
61—3 — Discussion of Formation MP No Yes 6 Months
of Inpurities
Analysis and Certification of Product Ingredients :
62—1 — Preliminary Analysis of MP Yes 12 Months
Product Samples
62—2 — Certification of Ingredient MP No Yes 12 Months
Limits
62—3 — Analytical Methods for MP No Yes 12 MonLhs
Enforcement of Limits
Other Requirements :
64-1 — Submittal of Samples N/A N/A No
1/ The 55% Fl serves as a manufacturing-use product.
2/ Cciupc ition: MP = r ruifacturing—use product.
-------
Data Re uireri nt
Cox ition /
Does EPA have Data
To Satisfy This
R&juir nt? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
§158.135 Toxicology
ACLYFE TESTING:
81—1 - Acute Oral Toxicity — Rat
EC
No
—-
Ye / 9 Months
81—2 — Acute Darnal ltxicity
- Rabbit
EC
No
——
YeS / 9 Months
81—3 — Acute Inhalation lbxicity
- Rat
EC
No
——
Yes / 9 Months
EC
No
--
Yes ./ 9 Months
EC
No
——
Yes / 9 Months
EC
No
——
Yes 9 Months
EC
of fluchioralin
No --
is registered as a manufacturing—use product.
No
81-4 Prinury Eye Irritation
81—5 Primary Dernal Irritation
81—6 Denial Sensitization
81—7 Delayed Neurotoxicity — Hen
7khe fl able intermediate f i (Fl)
EC = ulsifiable concentrate
/ Data to fill these re uir nts has been submitted. Hc ever, the data were generated by Cannon Labs. These data are
considered invalid until audited. The data submitted are stored under the fol1c iing MRID numbers; 00039435,
00039441, 00039437, 00039438, 00039444, 00039443, 00039436, and 00039442. No data were ad uate to fulfill the
denial sensitization study ra uireuent.
/ Data must be sutinitted within the indicated time—frame, based on the date of the Guidance Document.
° 9 Month IX ie Date is March 1, 1986 .
TABLE B
4OD1Cr SPECIFIC LWFA REC(JIREMEI flS FOR MANUFACrURING-USE PRDDUCIS Ctt AINING FLUCHLJJRALIN (55% Fl
-------
IV. SUBMISSION OF REVISED LABELING
Note : This section applies to end use products only to the
extent described in Section I (Regulatory Position and
Rationale). Otherwise, the following information pertains
exclusively to manufacturing use products.
FIFRA 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 CFR 162.10 (see
Appendix tV —i) 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 FIFRA sec. 6(b)(l).
A. Label Contents
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format 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 3. NET CONTENTS — A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., “1 pound 10 ounces” rather than
“26 ounces.” In addition to English units, net contents may
be expressed in metric units. See Appendix IV—l. (40 CFR
162.10(d)]
—38—
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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—l.
(40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase “EPA Est.” is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
See Appendix IV—l. [ 40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT — An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. See Appendix IV—l. (40 CFR
162.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT — For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word “Keep Out of Reach
on Front Panel Minimum Type Size of Children”
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
—39—
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Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
IsKeep Out of Reach of Children” must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. See Appendix IV—l.
[ 40 CFR 162.l0(h)(l)(ii)]
ttem 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 tV—i.
[ 40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD “POISON” - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word “Poison” shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. See Appendix IV—1. [ 40 CFR 162.10(h)(l)(i)1
Item 7D. STATEMENT OF PRACTICAL TREATMENT — A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix IV—l. (40 CFR 162.l0(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—l. (40 CFR 162.lO(h)(1)(iii)1
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—l. [ 40 CFR 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—l. (40 CFR 162.10
(h) (2) (i)]
—40—
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Item 83. 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—l. [ 40 CFR
162.10(h) (2) (ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammability statement . Precautionary statements relating
to flammability of a product are required to appear on the
label if it meets the criteria in Appendix IV—3. The require-
ment is based on the results of the flashpoint determinations
and flame extension tests required to be submitted for all
products. These statements are to be located in the side/back
panel precautionary statements section, precedei by the
heading “Physical/Chemical Hazards.” ote that. no signal
word is used in conjunction with the flammability statements.
2. Criteria for declaration of non—flammability . The
following criteria will be used to determine if a product
is non—flammable:
a. A “non—flammable gas” is a gas (or mixture of gases)
that will not ignite when a lighted match is placed
against the open cylinder valve.
b. A “non—flammable liquid” is one having a flashpoint
greater than 350°F (177°C).
c. A “non—flammable aerosol” is one which meets the
following criteria:
i. The flame extension is zero inches;
ii. There is no flashback; and
iii. The flashpoint of the non—volatile liquid
component is greater than 350°F (177°C).
3. Declaration of non—flammability . Products which
meet the criteria for non—flammability specified
above may bear the notation “non—flammable” or “non—
flammable (gas, liquid, etc.)” on the label. It may
appear as a substatement to the ingredients statement,
or on a back or side panel, but shall not be highlighted
or emphasized (as with an inordinately large type
size) in any way that may detract from precaution.
—41—
-------
4. Other physical/chemical hazard statements . When
chemistry data demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such statements
may address hazards of explosivity, oxidizing or reducing
capability, or mixing with other substances to produce
toxic fumes.
Item 9A . RESTRICTED USE CLASSIFICATION — FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section I
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency’s review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency’s classification decision.
A. Classification Labeling Requirements
If Section I of this Guidance Document indicates that
your product has been classified for restricted use, the
following label requirements apply:
1. Front panel statement of restricted use classification.
a. The statement “Restricted Use Pesticide must
appear at the top of the front panel of the label.
The statement must be set in type of the same
minimum size as required for human hazard signal
word (see table in 40 CFR 162.lO(h)(1)(iv).
—42—
-------
b. Directly below this statement on the front panel,
a sumirtary 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.
B. Compliance Schedules
No product with a use classified for restricted use
under this Standard may be released for shipment by the
registrant or producer after one year from the date of
issuance of -this Standard, unless such product bears the
restricted use classification. All products still in
channels of trade after two years from the date of issuance
of this Standard must be labeled for restricted use.
Item 9B [ There is no Item 9B1
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.
—43—
-------
Item 1OA. 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 lOB (There is no Item lOB]
Item 1OC. STORAGE AND DISPOSAL BLOCK — All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading “Storage and Disposal” in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix
IV—4 to determine the disposal instructions appropriate for
your products.
Item lOD. DIRECTIONS FOR USE — Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix IV—l. [ 40 CFR 162.101
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.
—44—
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V. IMSTRUCTIONS FOR SUBMISSION
A. For Manufacturing Products (MP) containing (name of
pesticide) as an active ingredient .
1. Within 90 days from receipt of this document, you must
submit 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
11—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 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—4
(Appendix 111—1).
c. Two copies of any required product—specific data.
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short—term data, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. The labeling should be either typewritten
text on 8—1/2 x 11 inch paper or a mockup of the labeling
suitable for storage in 8—1/2 x 11 inch files. The draft
label must indicate the intended colors of the final label,
clear indication of the front panel label, and the intended
type sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR 152.80—152.99
(enclosed) for latest requirements.
—45—
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3. Within the times set forth in Table A , you must submit
to the Registration Division all generic data, unless you are
eligible for the formulator’s exemption. If for any reason any
test is delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
B. For Manufacturing Use Products containing (name of pesticide)
in combination with other active ingredients
1. Within 90 days from receipt of this document, you must
submit the “FIFRA Section 3(c)(2)(B) Summary Sheet,” EPA Form
8580—1. Refer to Appendix 11—3 with appropriate attachments.
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.
C. For End Use Products containing (name of pesticide) 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 11—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.)
—46—
-------
2. Within 6 months from receipt of this document you must
submit:
a. Confidential Statement of Formula, EPA Form 8570—4.
b. Product—Specific Data Report, EPA Form 8580—4
(Appendix 111—1).
c. Two copies of any required product—specific data.
(Refer to Table C).
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short—term data, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. 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, clear
indication of the front panel label, and the intended type
sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR 152.80—152.99
(enclosed) for latest requirements.
3. Within the time frames set forth in Table A , submit all
generic data, unless you are eligible for the formulator’s
exemption.
D. For intrastate products containing (name of pesticide)
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 them how to submit an application for
registration.
E. Applications and other required information should be
submitted to the following address:
Robert Taylor
Product Manager
Registration Division (TS—767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW.
Washington, D.C. 20460
Phone No. (703) 557—1800
—47—
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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. 20460
—48—
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Appendix Il—i
Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a lstudy.u 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
nstudiesu generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by “Master Record Identifier,” or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six—digit “Accession Number”
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine—character
temporary identifier. These entries are listed after
all 4RID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards bf the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
—49—
-------
Appendix 11—1 (continued)
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four—digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self—explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
“received.”
(2) Administrative Number. The next element,
immediately following the word “under,” is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase “submitted by.” When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six—digit accession number follows
the symbol “CDL,” standing for “Company Data
Library.” This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456—A; the second, 123456—
B; the 26th, l23456—Z; and the 27th, 123456—AA.
—50—
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APPENDIX 11—2
OFFICE OF PESTICIDE PR X 4MS
R XISTRATION rP Nt RD BIBLIO APHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Fluchioralin Standard
MRID CIT?flON
00036206 BASF Wyandotte Corporation (1973) Stat nt Pr osing Cannon
NaxTe—Fluchloralin. (Unpublished study including letter dated
Mar 29, 1973 fran D.L. Klingiran to Ernald M. Yoder, received on
unknown date under 3G1395; (DL:095435—A)
00036211 BASF Wyandotte Corporation (19??) Confidential Statanent of the
Manufacturing Process of Bas 392—H. (Unpublished study received
on unkncwn date under 3G1395; CDL:095435—F)
00036657 c &ier r, B. (1975) Datecnination of Fluchioralin (Bas 392—H) and
Bas 392—D-4 Residues in Radish (Roots and Leaves), & uash and
Cotton Seed fran Greenville, Miss.: Report No. B—28. (Unpub-
lished study received Apr 14, 1975 under 5F1621; prepared by
Bio/dynaztu.cs, Inc. in cocperation with United States Testing
Co., Inc.; submitted by BASF Wyandotte Corp., Parsippany, N.J.;
L:09441 2—C)
00036665 Drescher, N.; Eschbach, J.C. (1975) Dete nination of Fluchloralin
(Bas 392—H) and Its Phenolic Metabolite, Bas 392—D—4, in Cotton
Foliage, Seed and Soil. Method no. 2A dated Apr 7, 1975. (Un-
published study received Apr 14, 1975 under SF1621; submitted by
BASF Wyandotte Corp., Parsippany, N.J.; CDL:094411—A)
00036673 Horton, W.E. (1975) Statistical Evaluation of the Recovery Data
Generated Using B%C riai1tural Chenicals Methods 2A and 15 for
Cotton, Soybeans, Soil and tationa1 Crcps: Report No. SR—21.
(Unpublished study received Apr 14, 1975 under 5F1621; submitted
by EASF Wyandotte Corp., Pars ippany, N.J.; (J)L: 094411—I)
00039445 Gilnan, M.R.; Sweitzer, T.L. (1972) Report: The Toxic Effects of
Technical Bas 392—H on Bluegill Sunfish and Rainbow Trcut: Lab-
oratory No. E—5338. (Unpublished study received on unknown date
under 3G1395; prepared by Cannon Laboratories, Inc., submitted
by BASF Wyandotte Corp., Parsippany, N.J.; CDL:093727—AD)
—51—
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MRID CIT TI0N
00039449 Gilaan, M.R.; Sweitzer, T. (1972) Report: Reproductive Study of Bas
392—H in B t hite .iai1: Laboratory No. E05109. (Unpublished
study received on unknown date under 3 (31395; prepared by Cannon
Laboratories, Inc., submitted by BASF Wyandotte Corp., Parsip—
pany, N.J.; CDL:093727—Ali)
00039450 Gi1i an, M.R.; S itzer, T. (1972) Report: Reproductive Study of Bas
392—H in Mallard Ducks: Laboratory No. E—5108. (Unpublished
study received on unknown date under 3G1395; prepared by Cannon
Laboratories, Inc., submitted by BPISF Wyandotte Corp., Parsip—
pany, N.J.; c L:093727—AI)
00047773 Aschan, R.E.; D wler, C.; Thui son, J.; et al. (1974) Residue
Study: Fluchioralin (Bas 392—H) in Soybeans: Field Eçerirent
No. tV—C—2—73. (Unpublished study LncludirK field eçerment
nos. iV—C—3—73, VII—A—14—13, VIII—B—25—73..., received Aug 23,
1974 under 5G1543; prepared in coc eration with Brayton Chaiucal
Co. and others, submitted by BASF Wyandotte Corp., Pars ippany,
N.J.; CDL:094201—A)
00047905 B SF Wyandotte Corporation (19??) Sumuery of Fluchioralin
(Bas 392—H) Residues in Soybeans. (Unpublished study received
Aug 23, 1974 under 5(31543; CDL:094203—A)
00047907 Dresdier, N.; Devine, J. (1973) Determination of Bas 392—H...and
Bas 392—D-4. . .Residues in Whole Cotton Plants, Cottonseed,
Cotton Gin Trash, and Soil by Gas ( iraiatogr phy. Method rio. 2
dated pr 30, 1973. (Unpublished study received Aug 23, 1974
under 5G1543; prepared in co eration with BASF, Geni ny and
Lake Ontario Envirorinental Laboratory, submitted by BASF Wyan-
dotte Corp., Parsippany, N.J.; L:094203-C)
00052467 Otto, S. (1974) Investigations on the Metabo1i n of Fluchioralin
(N— ( 2—Chioroethyl ) —2 ,6—dinitro—N-prqyl—4—tri fll.xDrmthyl ani-
line) in Soybeans: Lab Report No. 1215. (Unpublished study re-
ceived Aug 23, 1974 under 5(31543; prepared by B SF, G, submit-
ted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094204—B)
00052468 BASF, Nctiengesellschaft (1974) Investi tions on the Behavior of
N—Pr y1--N—(2—ch1orOethyl)—2 ,6-dinitro-4—trifluorut thy1 aniline
(BAS 392-H) in Soil: Lab Report No. 1214. (Unpublished study
received Aug 23, 1974 under 5G1543; submitted by BASF Wyandotte
Corp., Parsippany, N.J.; (DL:094204—C)
—52--
-------
MRID CITATION
00052469 Gilzian, M.R.; Joseph, T.C. (1973) Report: Determination of Resi-
dues in Milk and Tissues of Lactating C s foll iing the Oral
Administration of Radioactive BAS 392—H: Laboratory No. E—7778.
(Unpublished study received Aug 23, 1974 under 5G1543; pre-
pared by Cannon Laboratories, Inc., submitted by BASF Wyandotte
Corp., Parsippany, N.J.; ( L:094204—D)
00052470 Joseph, T.C. (1974) Report: Determination of Residues in Egg and
Tissues of Laying Hens follcMing the Oral ntthistration of
Radioactive GAS 392—H: Laboratory No.E—7959. (Unpublished study
received Aug 23, 1974 under 5F1543; perpared by Cannon Laboratories,
Inc., sublitted by BASF Wyandotte Cor. CDL:094204—E.)
00055010 Drescher, N.; Eschbach, J.C. (1975) Determination of Fluchioralin
(GAS 392—H) and Its Phenolic Metabolite, BAS 392—D--4, in Soybean
Foliage, Grain and Soil. Method no. 15 dated Mar 24, 1975.
(Unpublished study received Oct 12, 1976 under 7G1876; prepared
in cocperation with BPISF, P , Geruany, submitted by BASF Wyan-
dotte Corp., Parsippany, N.J.; CDL:095300—E)
00055011 Q. Tan, B. (1976) ecificity of B ricultural C nicals Method
No. 15 for the Determination of Fluchloralin in Peanuts (Forage,
Hay, Nuts, Hul is, Nut plus Hull and Process Fractions): Report
No. SR-38. (Unpublished study received Oct 12, 1976 under
7G1876; submitted by B SF Wyandotte Corp., Parsippariy, N.J.;
CDL:095300—F)
00055012 Gu an, B. (1976) Statistical Evaluation of the Recovery Data Gen-
erated Using B% P ricultural Q ica1s Method No. 15 with Ad—
denthn for Peanuts (Forage, Hay, Nuts, Hulls, Nut plus Hull and
Process Fractions): Report No. SR-40. (Unpublished study re-
ceived Oct 12, 1976 under 7G1876; submitted by BASF Wyandotte
Corp., Parsippariy, N.J.; L:095300-G)
00055013 Horton, W. (1976) Freezer Storage Stability of Fluchioralin (B.AS
392—H) and Its Phenolic Metabolite (Bas 392—D—4) in Peanut For-
age: Report No. SR—39. (Unpublished study received Oct 12, 1976
under 7G1876; submitted by BASF Wyandotte Corp., Parsippany,
N.J.; CDL:095300—H)
00085055 BASF Wyandotte Corporation (1980) Basalin (R) Herbicides Full Tol—
erartces and Registration for Use in Seed and Pod Vegetables and
Sunfl er. (Unpublished study received Oct 20, 1981 under 7969—
46; L:0704l9—B)
—53—
-------
MRtD CITATION
00085056 Craven, D.A.; Atwell, S.; Crosbie, S.; et al. (1980) Determination
of Fluchioralin (EAS 392—H) Residues in Seed and Pod Vegetable
(Suc ilent and Dry Form) Seed, Forage, and Hay Samples: Report
Mo. CR—2. (Unpublished study received Oct 20, 1981 under 7969—
46; prepared in cocperation with Craven Laboratories, Inc. and
others, submitted by BASF Wyandotte Corp., Pars ippany, N.J.;
CDL: 070419—D)
00085058 Craven, D.A.; Crosbie, S.; Harden, J.; et al. (1981) Determination
of Fluchioralin (BAS 392—H) Residues in Sunflc r Seed and Head
Samples: Report No. CR-3. (Unpublished study received Oct 20,
1981 under 7969—46; prepared in co eration with Craven Labora-
tories, Inc. and others, submitted by BASF Wyandotte Co.,
Parsippany, N.J.; CDL:070419—F)
00104436 Stauffer Ch ni.ca1 Co. (1978) Residue Studies of Vari is Ch nica1s
on Soybeans. (C roi1ation; unpublished study received Jun 20,
1979 under 476—2155; CDL:238641—C)
00106497 Cannon, G.; Krize, J. (1976) Fluchloralin Egg to Egg Reproduction
Study in Fathead Minn is: Laboratory No. 5E—6011; Report I—i.
(Unpublished study received Oct 12, 1976 under 7G1876; prepared
by Cannon Laboratories, Inc., submitted by B SF Wyandotte Corp.,
Wyandotte, MI; CDL:095302—B)
00106498 Willard, .3.; Atkins, E. (1976) The Toxicity of Basalin to Worker
ney Sees: Report 1—2. (Unpublished study received Oct 12,
1976 under 7G1876; prepared in co eration with Univ. of Cali-
fornia——Rivers ide, Dept. of Entatology, submitted by BASF
Wyandotte Corp., Wyandotte, MI; CDL:095302-C)
00106501 BASF Wyandotte Corp. (1976) Residues of Fluchioralin in Peanuts.
(Caipilation; unpublished study received Oct 12, 1976 under
7G1876; CDL:095304—A)
00106520 Nilles, G.; Zabik, M. (1974) Photoch niscry of bioactive can—
pounds. Multiphase photodegradation of basalin. J. Agr. Food
Chen. 22(4):684—688. (Also in unpublished submission received
Aug 23, 1974 under 5G1543; submitted by BASF Wyandotte Corp.,
Wyandotte, MI; CDL:094199—B)
—54—
-------
MRID CITM’ION
00106529 Otto, S.; Huber, R. (1975) The Metabo1i n of Fluchioralin in Soy-
beans after ot-uptake fran a Nutrient Solution: Report
No. 1259. (Unpublished study received Apr 14, 1975 under
5F1621; prepared by BASF, , W. Ger., submitted by BASF
Wyandotte Corp., Wyandotte, ; CDL:094403—B)
00106530 Huber, R.; Otto, S. (1975) Investigations on the Metabolisn of
Fluchloralin in Cotton (1974 Mississippi Field Metaboli n
Experinent): Report t Io. 1257. (Unpublished study received Apr
14, 1975 under 5F1621; prepared by BASF, AL, W. Ger., submitted
by BASF Wyandotte Corp., Wyandotte, MI; CDL:094403—C)
00106531 BASF Wyandotte Corp. (1975) Fluchloralin Residue Analyses——Soy-
bean. (Capilation; unpublished study received Apr 14, 1975
under 5F1621; CDL:094403—D)
00106532 Norris, F.; Clark, J. (1975) 1974 Michigan Field Metabo1i n Study:
Fluchioralin Soybean Metabolisn——Plots No. 1, 2, 3, 4: Part
I. Soil Incorporation of Fluchioralin 14-C Prior to Seeding with
Soybeans: Part im. Total Residue of Plant Parts &rir the
Gr ing Season. (Unpublished study received Apr 14, 1975 under
5F].621; submitted by B SF Wyandotte Corp., Wyandotte, MI; CDL:
094403—E)
00106534 BASF Wyandotte Corp. (1975) Analytical Data and Residue Methods:
Fluchioralin. (Caipilation; unpublished study received Apr
14, 1975 under SF1621; CDL:094404—A; 094407; 094408)
00106538 BASF Wyandotte Corp. (1975) Environnental th nistry: Fluchioral—
in. (Caxpilation; unpublished study received Apr 14, 1975
under 5F1621; CDL:094406—B; 094410)
00106540 BASF Wyandotte Corp. (1973) Plant Metabo1i n and Residue Analysis:
BAS 392—H. (Caipi].ation; unpublished study received on Un—
kncwn date under 3G1395; CDL:093723—B)
00106543 B?SF Wyandotte Corp. (1976) Residue Reports: Fluchioralin in
Peanuts. (Ca pilation; unpublished study received Oct 12, 1976
under 7G1876; CDL:095305—A)
—55—
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MRID CITATION
GS-0189001 BASP Wyandotte Corp. (1973) An rnal Metabolism Studies. Un-
published study.
GS-0189002 Boodee, W. (1975) Memorandum sent to J. Cummings dated
June 18, 1975 in EPA P 1 drninistrative Record for PP#5F1621:
Method Trial for Fluchioralin on Soybeans (Method No. 15).
1 p.
GS-0189003 Craven, D. (1981) Specificity of BWC Agricultural Chemicals
Method No. 15 as Modified in Addendum Number 2 for the
tennination of Fluchioralin (BAS 392-H) Residues in Seed
and Pod V etable (Succulent and Dry F rm) Seeds, Fbrage
and Hay: Report No. SR-71. Unpublished study. 21 p.
GS—0189004 Rosenthal,H.; Portnoy, C. (1981) Specificity of BWC
Agricultural Chemicals Method No. 15 as Modified in Addendum
Number 3 for the Determination of’ Fluchioralin (BAS—392—H)
Residues in Sunflower Seeds, Heads and Sunflower Seed
Process Fractions (Meal, Hulls, and Crude Oil): Report No.
SR-72. Unpublished study. 16 p.
-56—
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0MB Ao rova/No 2000-0468 A:: ::-
EPA REGISTRATION NO
FIFRA SECTION 3(C)(2)(S) SUMMARY SHEET
PRODUCT NAME
APP LICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With resoect 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:
0 1. I will jbmtt data in a timely manner to setisfy the following requirements. lithe test procedures I will use deviate from (or are not
OECD
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group,
Chemicals Testing Programme. 1 enclose the protøcols that I will use:
0 a. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, end any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
03. I enclose a completed “Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data” with
respect to the following da requirements:
04. I riquest that you amend my registration by deleting the following uses (this option is not availacie to applicants far new products):
O 5. I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
REGISTRANTS AUTHORIZED REPRESENTATIVE SIGNATURE DATE
-------
FE’IDIX II_
0MB Aoorove/ No 2 O-O468 -
CE TjFIC.’T ON OF A T MPT TO ENTER
INTO AN AGREEMENT WiTH OTHER REGISTRANTS
To qualify, Ce r,fy L four items) FOR DEVELOPMENT OF DATA
GUIDANCE DOCUMENT DATE
I. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document ACTIVE ING EDiEN1 ’
to submit data concerning the active ingredient:
NAME OF FIRM EPA COMPANY NUMBER
(This firm or grouc of firms is reierrea to below as ‘mv firm”.)
2. My firm IS willing to develoo 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 snare in the cost of developing, the following required
items or cata.
3. My firm h s offered in writIng to enter into such an agreement. Copies of the offers are attached. That offer was irre ocabIe and included an off er. to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reacned otherwise. This offer was made
to the following firm(s) on the following date(s):
NAME OF FIRM DATE OF OFFER
ii wever, none of those firm(s) accepted my offer
4. My firm requests that EPA not suspend the registration(s) of my firm’s product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does riot apply to applicants for new products.) I give EPA permission to disclose this statement upon request. —
TYPED NAME SIGNATURE DATE
-------
Appendix 111—1
P D(C SPECIFIC A R RT
EPA Registration No. Guidance Doo.m nt for
Late
Registration
Guideline No.
Name of Test
Test not
ra uired
for my
product
listed
above
(ched
bel i)
I am car lying with
data r uir nents by
(For EPA Use Only)
Accession Numbers
Assigned
Citing tIRID*
Subnu. t—
ting
Data
(At—
tached)
§158.20
PRO WCT
H 4ISTRY
61—1 1 Identity of
ingredients
61—2
Stat nt of
ca osition
61—3
Discussion of
fo tion of
ingredients
62—1
Preliminary
analysis
62—2
Certification of
1 mtits
62—3
Analytical nethods
for enforcai nt
limits
63—2
Color
63—3
Physical state
63—4
Odor
63—5
Melting point
63—6
Boiling point
63—7
Density, txilk-
density, or
specific_gravity
63—8
Solubility
63—9
Vapor pressure
63—10
Dissociation
constant
63—11
Octanol/wa ter
partition
coefficient
63—12
pH
—59—
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Chapter 1——Environmental Protection Agency
§162.10 Labeling requirements.
(a) General——(l) 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:
(i) 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 Cc) of this
section;
(iii) The net contents as prescribed in paragraph Cd) 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. Fiowever, 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 appear
on or be securely attached to the immediate container of the
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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
delivery.
(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, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve. - - -
(5) False or misleading statements . Pursuant to section
2(q)(1)(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;
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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 reglstration. 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:
Ci) 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 is a liquid, the net content statement
shall be in terms of liquid measure at 68°F (20°C) and shall be
expressed in conventional American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or 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 stiipment 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 size 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.
(f) 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——(l) 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 uanalysisnl 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.
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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 pesticide
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
required on the front panel of the labeling and those which may
appear 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 cateqories I
I
I I
III iv
Oral LD 0 Up
to and
including
From 50 thru
500 mg/kg
From 500 thru
5000 mg/kg
Greater than
5000 mg/kg
50mg/kg
Inhalation LC 50
Up
to and
including
From .2 thru From 2 thru
2 mg/liter I 20 mg/titer
Greeter than
20 mg/liter
j
.2 mg/I iter I
I
I
Dermal LD 50
Up
to and
including
From 200
thru 2000
From 2,000 thru
20,000
Greater than
20,000
200 mg/kg
Eye effects
Corrosive;
Corneal opacity
No combat opacity;
No Irritation
corneal opacity
reversible
irritation
not reversible
within 7 days;
reversible
I
within 7 days
Irritation
within 7 days
persisting for
I
I
ldays
I
Skin effects
Corrosive
Severe irritation
Moderate irritation
Mild or slight
irritation at
at 72 hours
at 72 hours
I
.
72 hours
I
I
(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 background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word “poison.”
(B) Toxicity Category II .
criteria of Toxicity Category
the signal word “Warning.”
(C) Toxicity Category III .
criteria of Toxicity Category
the signal word “Caution.”
(D) Toxicity Category IV .
criteria of Toxicity Category
the signal word “Caution.”
All pesticide products meeting the
II shall bear on the front panel
All pesticide products meeting the
III shall bear on the front panel
All pesticide products meeting the
IV shall bear on the front panel
—65—
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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 likelihood 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.
(iii) Statement of practical treatment——(A) Toxicity
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, permit
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)(l)(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 panel
in square inches
Points
Required
signal word,
all capitals
“Keep out
of reach of
Children
5 and under . . . . . . . . . . .
Above5tolO. . . . .
Abovel0tol5 ........ .
Above 15 to 30
Over 30 . . . . .
6
10
12
14
18
6
6
8
10
12
—66—
-------
(2) Other required warnings and precautionary statements . The
warnings and precautionary statements as required below shall appear
together on the label 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.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
I Precautionary statements by toxici1’ category
Toxicity
category
Oral, inhalation, or dermal toxicity
Skin and eye local effects
I • • •
(poisonous) if swallowed (Inhaled or
Corrosive, causes eye and skin demage (or
I
absorbed through skin). Do not breathe
skin irritation). Do not got in eyes, on
vapor (dust) or spray mist). Do not get
skin, or on clothing. Wear goggles or face
in eyes, on skin, or on clothing (Front
shield and rubber gloves when handling.
panel statement of practical treatment
Harmful or fatal if swallowed.
required.).
(Appropriate first aid statement required.)
II . . .
May be fatal if swallowed (inhaled or
Causes eye (and skin) irritation. Do not
absorbed through the skin). Do not breathe
get in eyes, on skin, or on clothing.
I vapors (dust or spray mist). Do not get in
Harmful if swallowed. (Appropriate first
I eyes, on skin, or on clothing. (Appropriate
aid statement required.).
first aid statements required.).
Ill . . .
Harmful If swallowed (inhaled or absorbed
Avoid contact with skin, eyes or clothing.
through the skin). Avoid breathing vapors
in case of contact inuned lately flush
(dust or spray mist). Avoid contact with
eyes or skin with plenty of water. Get
skin (eyes or clothing). (Appropriate
medical attention If Irritation persists.
first aid statement required.].
I V •. •
I (No precautionary statements required.].
iNo precautionary 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
—67—
-------
damage. Examples of the hazard statements and the circumstances
under which they are required follow:
(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD 50 of 100 or less, the
statement “This Pesticide is Toxic to Wildlife” is required.
(B) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LC 50 of 1 ppm or less, the statement
“This Pesticide is Toxic to Fish” is recuired.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD 50 of 100 mg/kg or less, or
a subacute dietary LC 50 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 the
flammability or explosive characteristics of the pesticide are
required as follows:
I I
Flesh point Repuired text
(A) PRESSURIZED CONTAINERS
I I
Flash point at or below 20F; If there is a Extremely flammable. Contents under pressure.
flashback at any valve opening. I Keep away from fire, sparks, and heated
surfaces. Do not puncture or incinerate I
container. Exposure to temperatures above
I 130F may cause bursting.
Flash point above 2O F end not over 80F or if I Flammable. Contents under pressure. Keep away
the flame extension is more than 18 in. long J from heat, sparks, and open flame. Do not
at a distance of 6 in. from the flame. puncture or Incinerate container. Exposure to
temperatures above 130’F may cause bursting.
Al I other pressurized containers Contents under pressure. Do not use or store
near heat or open flame. Do not puncture or
Incinerate container. Exposure to tempera-
tures above 130’F may cause bursting.
I (B) NONPRESSURIZ
ED CONTAINERS
At or below 20’F . Extremely flammable. Keep away from fire,
sparks, and heated surfaces.
Above 2O F end not over 80F . . . . . . . . • .j Flammable. Keep away from heat and open flame.
Above 80F and not over 150F . . . . . . . . . Do not use or store near heat or open flame. I
—68—
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(i) Directions for Use——(l) General requirernents——(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.
(iii) 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
(4) 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:
(1) The label clearly states that the product is for use only
by physicians or veterinarians;
(2) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse 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:
(1) There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes;
—69—
-------
(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 § 162.1O(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.lOth)(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]
—70—
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APPENDIX IV—2
LABELING REX)UIREMENTS OF ThE FIFRA, AS AMENDED
IT 4
LABEL EL 24EN
APPLICABI LIlY
OF RJIREMEN
PLAC 4EN ON LABEL
(X14ME2 fl’S
REQUIRED
PREFERRED
1
Product name
All products
Front panel
Center front
panel
2
Canpany name
and address
All products
None
Bottan front
panel or end
of label text
It registrant is not the producer, must
be qualified by “Packed for . . .
uDistribeted by. . .,“ etc.
3
Net contents
All products
None
Bottan front
panel or end
of_label_text
May be in metric units in addition to
U.S. units
4
EPA Reg. No.
All products
None
Front panel
ilust be in sij ilar type size and run
parallel to other type.
5
EPA Est. No.
All products
None
Front panel,
iinrrethately
before or
fo llcx4 i r j
Reg._No.
May appear on the container instead of
the label.
6A
Ingredients
statement
All products
Front panel
Immediately
follcMing
product_name
Text must run parallel with other text
on the panel.
68
PcAJnc /gallon
statement
Liquid products
where dosage
given as lbs.
ai/unit area
Front penel
Directly belc
the ma in
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 ra uirements.
7B
Signal word
All products
Front panel
Immediately
be1a , child
hazard
warning
Note type size requirements.
-------
APPENDIX IV-2 (continued)
ITEM
LABEL ELEMENT
APPLICABI LITY
OF REQUIRE24EN’F
PLACEMENT ON LABEL
—
(Xiit4Etffs
REQUIRED
PREFERRED
7C
Skull & cross—
bones and word
POISON (in red)
All products
which are Cat-
egory I based
on oral, der-
m31, or inhala-
tion_toxicity
Front panel
Both in close
proximity to
signal word
7D
Statanent of
practical
treatment
All products
in Categories
I, II, and III
Category I:
Front panel
unless refer-
ral statanent
is used.
Others;
Graiped with
side panel
precautionary
sta t nents.
Front panel
for all.
7E
Referral
statem nt
All products
where pre-
cautionary
labeling
appears on
other than
front_panel.
Front panel
Must be gtxxiped under the headings in
BA, 8B, and 8C; preferably blocked.
8
Side/back panel
precautionary
stateue nts
All products
None
Top or side
of back panel
preceding
directions
for use
8A
Hazards to
hunans and
daiestic
anima is
All products
in Categories
I, II , and III
None
Same as above
Must be preceded by appropriate signal
word.
RB
Envi rorunental
hazards
All products
None
Same as above
Environmental hazards include bee
caution where applicable.
-------
APPENDIX IV—2 (continued)
ITE 4
LABEL ELFIIENF
APPLICABI LIlY
OF REQUIRE 4ENT
PLACEMENT ON LABEL
CX 4I4ENTS
REQUIRED
PREFERRED
8C
Physical or
cha i c a1
hazarde
All pressurized
products, others
with flash
points under
150°F
None
Same as above
9A
Restricted
blodc
All restricted
products
Tcp center
of front
panel
Preferably
blocked
Includes a stat nt of the terms of
restriction. The words “RESTRICrED USE
PESTICIDE” must be same type size as
signal word.
9C
Misuse
stat nt
All products
Immediately
fo1lo iing
heading of
direct ions
for_use
1OA
1OC
Reentry
state nt
Storage and
disposal blodc
All
cholinesterase
inhibitors
All products
In the
directions
for use
In the
directions
for use
Immediately
after misuse
stat iient
Immediately
before
specific
directions
for use or
at the end of
directions
for_use
Must be set apart and clearly distin—
guishable fran fran other directions
for use.
1OD
Directions
for use
All products
None
None
May be in metric as well as U.S. units
-------
Appendix IV—3
PHYSICAL-CHEMICAL HAZARDS
Criteria
Required Label Statement
I. Pressurized Containers
A. Flashpoirit at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
II. Non—Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
—74—
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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 minimum type size listed below:
Required type size
Size of label for the heading
front panel in STORAGE AND DISPOSAL
square inches (all capitals)
10 and under 6 point
Above 10 to 15 .8 point
Above 15 to 30 . . . . . . 10 point
Ove r 3 0 . . . . . . . . 1 2 0 i n t
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. Storage Instructions :
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
—75—
-------
Appendix IV—4
(continued)
4. tristructions 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 storageinstructions tor 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:
The labels of all products, except domestic use, must
contain the statement, “Do not contaminate water, food,
or feed by storage or disposal.”
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
appearing on the “Acutely Hazardous” Commercial Pesticide
Products List (RCRA “E” List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
“Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or—the Hazardous Waste representative at the
nearest EPA Regional Office for guidance.”
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the “Toxic” Commercial Pesticide Products
List (RCRA “F” List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
—76—
-------
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
s t a t eme n t:
“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—aerosoiproductS
(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.
—77-.
-------
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
1’ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
Metal
containers
(non—aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
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)
—78—
-------
Appendix IV—4
(continued)
Pesticides that are hazardous wastes under 40 CFR 261.33(e) and (f)
when discarded.
“ Acutely Hazardous” Commercial Pesticides (RCRA “E ” List)
Active Ingredients, (no meEts) :
Acrolein
Al di ca rb
Aldr in
Allyl alcohol
Aluminum phosphide
4—Axni nopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p—Chloroanil me
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2—Cyclohexyl-4 , 6—dinitrophenol
Dieldrin
0,0—Diethyl S— [ 2—ethylthio)ethyll phosphorodithioate
(disulfoton, Di—Syston)
0,0—Diethyl 0—pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0—Dimethyl 0—p—nitrophenyl phosphorothioate (methyl parathion)
4,6—Dinitro—o—cresol and salts
4 ,6—Dinitro—o--cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
riethomyl
a lpha—Naphthyl th iourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradart)
Parathion
—79—
-------
Appendix IV-4
(continued)
“ Acutely Hazardous” Commercial Pesticides (RCRA “E” List)
Active Ingredients continued :
Pheriylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
O,O,O,O—Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Th iofanox
Toxaphene
Wa r far i n
Zinc phosphide
—80—
-------
Appendix LV—4
(continued)
“ Toxic” Commercial Pesticide Products (RCRA “F” L ist)
Active Ingredients :
Acetone
Acrylonitrile
Am i t role
Benzene
Bis(2—ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachioride
Chioral (hydrate)
Chiordarie (technical)
Chiorobe nzene
4 —Chloro—m—cresol
Chloroform
o—Chlorophenol
4-Chloro—o—toluidirie hydrochloride
Creosote
Cresylic acid
Cyclohexane
DecachlorooctahydrO—l,3,4—metheflO—2H—CYC1ObUtaIC,d]—Pentalefl2—Ofle
(kepone, chiordecone)
1,2—Dibromo—3-chloropropane (DBCP)
Dibutyl phthalate
S—3,3—(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o—Dichlorobenzene
p—Dichlorobenzene
Dichiorodifluoromethane (Freon 12®)
3,5—Dichloro—N—(l,l-diinethyl—2-propynyl) benzamide (pronamide,Kerb)
Dichioro diphenyl dichioroethane (DDD)
Dichioro diphenyl trichioroethane (DDT)
Dichiorethyl ether
2,4—Dichiorophenoxyacetic, esters and salts (2,4—D)
1 , 2—Dichioropropane
1, 3—Dichioropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,’P—dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichioride
Ethylene oxide
Forma ldehyde
Furfura 1
Rexachlorobenzene
Hexachiorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
—81—
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Appendix IV—4
(continued)
“ Toxic” Commercial Pesticide Products (RCRA “F” List)
Active tngredients :
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2’—Methylenebis (3,4 ,6—trichiorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4—Methyl—2—pentanone (methyl isobutyl ketone)
Naphtha lene
i trobenze ne
p—Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0—diethyl, methyl ester
Propylene dichioride
Pyridine
Resorc inol
Saf role
Selenium disulfide
Silvex
1,2,4, 5—Tetrachlorobenzene
1 , 1 , 2 , 2—Tetrachioroethane
Tetrachloroethylene
2,3,4 , 6—Tetrachiorophenol
Thiram
Toluene
1,1, l—Trichloroethane
Trichloroethy lene
Trichioromonofluoromethane (Freon 11
2,4, 5—Trichlorophenol
2,4, 6—Trichlorophenol
2,4,5—Trichiorophertoxyacetic acid (2,4,5—T)
Xylene
—82—
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Appendix EV—4
(continued)
“ Toxic” Commercial Pesticide Products (RCRA “F” List)
Inert Ingredients :
Acetone
Ace ton i t r i 1 e
Acetophenone
Acrylic acid
Aniline
Be nzene
Ch lorobenzene
Chloroform
Cyc lohexane
Cyclohexanone
Dichiorodifluoromethane (Freon 12 )
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1 , 4—Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketorie
Methyl raethacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1, 1—Trichioroethane
1, 1, 2—Trichloroethane
Trichiorofluoromethane (Freon ll )
Vinyl chloride
Xylene
—83—
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