COMPOSITE
GUIDANCE PACKAGE
FOR SIX REGISTRATION STANDARDS
This package represents Che "boiler-plate" guidance for preparation of
pesticide reregistration submissions, plus detailed information pertaining
to each of the following active ingredients listed below:
Active Ingredient Product Manager
0,0,0,0-Tetrapropyl Dithiopyrophosphate William Miller
(AsponR) 426-9458
4-Aniinopyridine (AvitrolR) William Miller
426-9458
l,4-Dichloro-2,5 Ditnethoxybenzene Henry Jacoby
(Chloroneb) 755-2562
2-Qiloro-H(2-ethyl-6-methylphenyl) Richard Mountfort
-N-(2-methoxy-l-methylethyl) 755-1397
(Metolachlor)
5-Ethoxy-3-trichloromethyl Henry Jacoby
-1,2,4-thiadiazole 755-2562
(Terrazole ^)
3-(alpha-acetonylfurfuryl) William Miller
-4-hydroxycoumarin) 426-9458
Fumarin1 and its Sodium Salt
-------
COMPOSITE
GUIDANCE PACKAGE
FOR SIX REGISTRATION STANDARDS
This package represents Che "boiler-plate" guidance for preparation of
pesticide reregistration submissions, plus detailed information pertaining
to each of the following active ingredients listed below:
Active Ingredient Product Manager
0,0,0,0-Tetrapropyl Dithiopyrophosphate William Miller
(AsponR) 426-9458
4-Aniinopyridine (AvitrolR) William Miller
426-9458
l,4-Dichloro-2,5 Ditnethoxybenzene Henry Jacoby
(Chloroneb) 755-2562
2-Qiloro-H(2-ethyl-6-methylphenyl) Richard Mountfort
-N-(2-methoxy-l-methylethyl) 755-1397
(Metolachlor)
5-Ethoxy-3-trichloromethyl Henry Jacoby
-1,2,4-thiadiazole 755-2562
(Terrazole ^)
3-(alpha-acetonylfurfuryl) William Miller
-4-hydroxycoumarin) 426-9458
Fumarin1 and its Sodium Salt
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460 „
26047
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
Certified Mail
Registrant's Address
SUBJECT: Initiation of Reregistration Process for Pesticide Products
Containing
as the Single Active Ingredient
Dear Registrant:
In accordance with the Federal Insecticide, Fungicide, and Rodenticide
Act, as amended, (FIFRA), the Office of Pesticide Programs, EPA, has
begun the reregistration process for pesticide products containing the
subject ingredient. Significant changes to the statute were made in
1972, 1975 and 1978; thus, current requirements may be substantially
different from those in effect at the time your product(s) was regis-
tered. The first phase of reregistration requires that you (1) make a
commitment to the Agency regarding data development and (2) subsequently,
submit revised product labeling and associated information.
This mailing contains the Registration Standard, a Guidance Package for
preparation of submissions, as well as a listing of your affected products
(Attachment A) and a separate list of registrants with products containing
this active ingredient (Attachment B). The latter list is for the purpose
of cooperative data development. Together they should provide you with
all the information you need to meet the necessary requirements and to
allow you to continue your registration(s) in effect.
The Registration Standard sets out the Agency's evaluation of all avail-
able data pertaining to the subject chemical and its registered uses,
EPA's assessment of the hazards associated with uses of the pesticide, as
best they can be assessed with the data currently available, and its
rationale for the regulatory actions being taken at this time.
The Guidance Package, together with the first and second chapters of the
Standard contain instructions describing what you must do to bring your
product(s) into compliance with the Registration Standard. Products not
brought into compliance with the Registration Standard will be subject to
suspension and/or cancellation.
-------
Specifically, the enclosed guidance package does the following:
1. Introduces the purpose for the guidance package.
2. Explains data compensation.
3. Explains the Agency's policy regarding data submission and
identifies the data, both generic and product specific in
three tables, that must be submitted to complete the Agency's
evaluation of each product.
4. Sets out time frames for submission of labeling, submission
of required data, and compliance with classification and
packaging requirements.
5. Explains how to revise labeling in accordance with the Standard
and provides classification and package instructions.
6. Provides submission instructions.
Additionally, we suggest that you review the first chapter of the Regis-
tration Standard prior to reading the guidance Package, since that chapter
describes the Registration background and Standard concept. Because of
the variety and complexity of the requirements, and the short statutory
time frames available for certain actions, it is essential that you under-
stand the specific requirements and procedures in order that you may
respond in a correct and timely manner. Since a part of these require-
ments is under Section 3(c)(2)(B) of FIFRA, your first response may be
required within 90 days from receipt of this letter. Please note that _vf
you do not respond, or do not comply fully with the requirements, your
application may be rejected or your product registration cancelled or
suspended?
If, after reviewing this material, you do not understand what you must
do, or how or when you must respond, please contact the Product Manager
listed below who will assist you in every reasonable way.
(202)
Registration Division TS-767
Office of Pesticide Programs
Environmental Protection Agency
Washington, D. C. 20460
Douglas D. Campt
Director
Registration Division (TS-767)
-------
Attachment A
PRODUCTS AFFECTED BY THIS
REREGISTRATION PROCESS
Following is a list of your products affected by this reregistration
process. If this list is incomplete or inaccurate in any way, please
notify the Product Manager (PM) identified in the letter.
-------
Attachment B
REGISTRANTS WITH PESTICIDE PRODUCTS CONTAINING
THE ACTIVE INGREDIENT
The information attached will allow registrants with pesticide products
containing the above ingredient to contact one another regarding joint
data development or sharing the cost of data development under section
3(c)(2)(B) of FIFRA. This information includes the following: EPA Reg.
No., company name, company's address, active ingredient, percentage of
active ingrident and type of formulation such as Manufacturing Use
Product (MUP), Technical Product (TP), wettable powder (WP), and
emu 1sifiable concentrate (EC).
-------
GUIDANCE PACKAGE FOR
REREGISTRATION OF PESTICIDE PRODUCTS
IN COMPLIANCE WITH
REGISTRATION STANDARD
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION DIVISION
WASHINGTON, D.C.
SEPTEMBER 30, 1980
-------
Table of Contents
Section Page
I. Introduction 1
II. Data Compensation 1
III. Submission of Generic Data under FIFRA 5
IV. Requirement for Submission of Product-Specific Data Under
FIFRA S (3) (C) (2) (B) 12
V. Submission of Revised Labeling, Classification, and Packaging
Information 13
A. Label Contents 14
1. Product Name 14
2. Company Name and Address 14
3. Net Contents 15
4. Product Registration Number 15
5. Producing Establishment Registration Number 16
6A Ingredient Statement 16
6B Pounds per Gallon Statement 16
7. Front Panel Precautionary Statements 17
7A Child Hazard Warning Statements 17
7B Signal Word 17
7C Skull and Crossbones and Word Poison 18
7D Statement of Practical Treatment 18
7E Referral Statement 18
-------
Table of Contents (cont'd)
8. Side/Back Panel Precautionary Labeling 18
8A Hazard to Humans and Domestic Animals 18
SB Environmental Hazard 19
8C Physical or Chemical Hazard 19
9. Product Classification 21
9B Omitted 28
9C Misuse Statement 28
10A Re-entry Statement 28
IOC Storage and Disposal Block 28
10D Directions for Use 28
B. Collateral Information 29
C. Special (Child Resistant) Labeling Requirements 29
VI. Instructions for Submission 30
VII. Statement on Agency Position Regarding Court Suits Involving
FIFRA S (3) (C) (1) (D) 33
-------
APPENDICES
II-l Data Compensation Statement: Reregistration
II-2 Product Specific Data Report
III-l Generic Data Exemption Report
III-2 FIFRA § 3(c)(2)(B) Summary Sheet
III-3 State of Willingness to Enter Into an Agreement
With Other Registrants For Development of Data
V-l 40 CFR § 162.10 Labeling Requirements
V-2 Table of Labeling Requirements
V-3 Physical-Chemical Hazards Labeling Statement
V-4 40 CFR § 162.11 Use Classification
V-5 Storage and Disposal Statements
V-6 40 CFR § 162.16 Special Packing Requirements
-------
I. INTRODUCTION
This guidance package has been prepared to provide you, the registrant,
with specific information with which you may maintain in effect your
current registration(s) that is subject to this Registration Standard.
(Refer to the cover letter's attachment for a listing of your affected
products.) If for any reason you decide to request that the Agency
discontinue the registration of any of your products subject to the
registration requirement in this standard, please notify the Product
Manager named in the cover letter, within 90 days from the receipt of
this package, that you wish to voluntarily cancel the registration(s).
If you decide to maintain your product registration(s), you must provide
the information described in the following package within the time frames
outlined.
II. DATA COMPENSATION
As part of your application for reregistration, you must comply with the
data requirements of FIFRA Section 3(c)(1)(D) by including with your
application a completed Data Compensation Statement (Appendix II-l).
That form includes:
A. A statement that you offer to pay compensation to other persons with
regard to the application to the extent required by FIFRA Sections
3(c) (1)(D) and 3(c)(2)(D)
-------
B. A statement acknowledging that if EPA approves your application for
reregistration, the approval will be based on BPA's consideration of
the following:
1. All the existing "generic" data* which, according to the table,
"Generic Data Requirements for Manufacturing Use and End Use
Products" (Table A at the end of Section III) , is relevant to
EPA's evaluation of the registrability of your product (taking
into account your product's composition and formulation
category, and the uses of your product which its label will
permit) .
2. The "product-specific" data* which you have listed on the form
entitled "Product-Specific Data Report" (Appendix II-2).
C. A statement that you have furnished an offer to pay compensation to
the person(s) listed below in the manner specified:
1. Persons to whom offers must be made: An offer must be furnished
to each person who, according to the Standard, was the original
submitter of any of the generic or product specific data upon
which approval of your application will be based, except that:
a. You need not furnish an offer with respect to data that
were originally submitted prior to January 1, 1970.
—' For an explanation of the terms "generic" data and "product-specific"
data, see pp. 3-4 of the Registration Stai.dard.
-------
b. FIFRA Section 3(c)(2)(D) provides that you need not furnish
an offer with respect to any "generic" data, _if your
product is an end-use product and ^f its active ingredient
will be present in your product solely because of the
incorporation into your product of another registered
manufacturing-use product which contains that active
ingredient and which you purchase from another producer.
Note: This exemption does not cover "product-
specific" data.
c. Many data submitters have informed EPA that they do not
wish to receive offers under FIFRA Section 3(c)(1)(D). Of
the various persons who submitted data listed in the
Standard's bibliography as supporting the Standard, only
the following firms have not waived their rights to receive
offers:
-------
COMPANIES THAT MAY NEED TO RECEIVE
OFFERS TO PAY FOR § 3(C)(1)(D)
AsponR
Chevron Chemical Company
Ortho Division
940 Hensley Street
Richmond, California 94804
Stauffer Chemical Company
Labeling and Registration Department
1200 South 47th Street
Richmond, California 94804
AvitrolR
Avitrol Corporation
7644 E. 46th Street
P.O. Box 45141
Tulsa, Oklahoma 74145
Chloroneb
E. I. duPont de Nemours Company
Legal Department
Wilmington, Delaware 19898
0. M. Scott & Sons Company
Marysville, Ohio 43040
Metolachlor
Ciba-Geigy Corporation
410 Swing Road
Greensboro, North Carolina 27409
TerrazoleR
Olin Corporation
120 Long Ridge Road
Stamford, Connecticut 06904
Mallinckrodt, Incorporated
Second and Mallinckrodt Streets
St. Louis, Missouri 63147
3 (a)
-------
COMPANIES THAT MAY NEED TO RECEIVE OFFERS
TO PAY FOR § 3(C)(1)(D) (cont'd)
FumarinR
Amchem Products Incorporated
Brookside Avenue
Ambler, PA 19002
3(b)
-------
d. You need not furnish an offer to any person with whom you
have already agreed in writing concerning the amount (if
any) and terms of compensation payable under FIFRA Section
3(c)(1)(D) in connection with the reregistration of your
product.
e. You need not furnish an offer with respect to any data
unless the data were submitted to EPA (or its predecessor
agencies) to support an application for registration,
amended registration, or reregistration; to support or
maintain in effect an existing registration; to support an
application for an experimental use permit; or to support a
petition for a tolerance, food additive regulation, or
other clearance under the Federal Food, Drug and Cosmetic
Act which was a prerequisite to a FIFRA registration action.
2. Form of the offer: You must furnish each person who is entitled
to receive an offer the following information, in writing:
a. A notification of your intent to apply for reregistration
under the Standard, and the name, active ingredient, and
intended uses of your product.
-------
b. An offer to pay the person compensation, with respect to
approval of your application, to the extent required by
FIFRA Sections 3(c)(l)(D) and 3(c)(2)(D), and an offer to
begin negotiations to set the amount and terms of
compensation.
c. Your name, mailing address, and telephone number.
III. REQUIREMENT FOR SUBMISSION OF GENERIC DATA UNDER FIFRA SECTION 3(c)(2)(B)
A. This portion of the Guidance Package is a Notice issued under the
authority of FIFRA Section 3(c)(2)(B). EPA has determined that
additional generic data described in this Notice must be submitted to
EPA for evaluation in order to maintain in effect the registration(s)
of your product(s) identified as an attachment to the cover letter
accompanying this Guidance Package. As required by FIFRA Section
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. Entitlement of Certain End-Use Registrants to An Exemption. Under
the circumstances described in this section III(B), EPA will refrain
from suspending the registration of an end-use product even if its
registrant does not submit data in response to this Notice. EPA's
position is based on the intent of Congress as set forth in FIFRA
Section 3(c)(2)(D). Under that section, if generic data on an active
ingredient had already been submitted to EPA, an applicant for
registration of an end-use product would be excused from the normal
Section 3(c)(1)(D) requirement of submitting or citing, and offering
to pay compensation for, those data as a condition of obtaining
registration. To qualify for that exemption, the active ingredient
must be present in his product solely as a result of his
incorporation into his product (during formulation or packaging) of a
manufacturing-use product containing that active ingredient
registered under FIFRA and purchased from another producer. The
object of this provision is to simplify data compensation by making
compensation for the generic data on the active ingredient an element
of the market cost of registered manufacturing-use products, so that
formulators or other registrants who purchase such products need not
separately offer to pay for data on the active ingredient.
-------
EPA has concluded that these principles should also apply in the
closely analogous situation presented by this Section 3(c)(2)(B)
requirement. However/ principles of fairness to those who incur
expenses of data generation and submission make it necessary to
ensure that a registrant be exempted from this data submission
requirement only if the active ingredient in his product is being
purchased from a firm which is required to submit (or to offer to
share in the cost of obtaining) the generic data required by this
Notice.
If a registrant who is subject to this Section 3(c)(2)(B) Notice
fails to comply with the data submission requirement, the
Administrator may suspend his registration. However, this authority
is discretionary, and the Administrator will not exercise it to
suspend a registration if
1. the registration is for an end-use product, as opposed to a
manufacturing-use product; and
2. the active ingredient in the end-use product is present solely
as the result of the incorporation into that product (during
formulation or packaging) of a manufacturing-use product which
contains that active ingredient, is registered under FIFRA, and
is purchased by the registrant; and
-------
3. the registrant completes and executes a "Generic Data Exemption
Statement" (Appendix III-l) for the end-use products, and
submits it to EPA within 90 days of receipt of this Notice; and
4. one or more registrants actually does undertake to submit, and
does submit, all the data required by this Notice.
C. What Generic Data Must Be Submitted. You may ascertain which generic
data you must submit by consulting Table A at the end of this
section. That table shows all the generic data needed to evaluate
the continued registrability of all products to which the Standard
applies, and the dates by which the data must be submitted . The
required data must be submitted and any necessary studies must be
conducted in accordance with EPA approved protocols, The Pesticide
Registration Guidelines, V or data collected under the approved
protocols of the Organization for Economic Cooperation Development
(OECD) which are yet to be published. If you wish not to develop
data which are necessary to support the continued registration of
certain uses appearing in your current labeling, you may delete those
uses at the time you submit your revised labeling for registration.
V The Pesticide Registration Guidelines were proposed in two separate
publications. On July 1, 1978 EPA issued proposed guidelines for product
chemistry, environmental chemistry, and fish and wildlife hazard testing,
43 FR 29696. The Agency published proposed human hazard guidelines on
August 22, 1978, 43 FR 37336.
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Also for certain kinds of testing (generally Ecological Effects), EPA
requires the test substance to be a "typical formulation," and that in
those cases EPA needs data of that type for each major formulation category
(e.g., emulsifiable concentrates, wettable powders, granulars, etc.).
These are classified as generic-data and when needed are specified in
Table A. EPA may possess data on certain "typical formulations" but not
others. Note: The "typical formulation" data should not be confused with
product-specific data which are required on each formulation, regardless of
type of formulation. Product-specific data are further explained under
Section IV of this document and are specified in Tables B and C at the end
of this Section.
D. Options Available For Complying With Requirements to Submit Data.
You must submit to EPA within 90 days of your receipt of this Notice a com-
pleted copy of the form entitled "FIFRA § 3(c) (2) (B) Summary Sheet" (Appendix
III-2) 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. Attach a completed "Generic Data Exemption Statement" (Appendix III-l)
2. (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 Registration 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.
-------
3. 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 at
the same time notify EPA which registrant(s) are parties to the
agreement. At least one of the parties to the agreement must
respond to this Notice in the manner specified by paragraph III
(0)(1) above.
4. File with EPA a completed "Statement of Willingness to Enter
Into An Agreement With Other Registrants for Development of
Data* (Appendix III-3) ^/.
FIPRA Section 3(c) (2MB) authorizes joint development of data by two or
more registrants, and provides a mechanism by which parties can ootain 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.
In SPA's opinion, joint data development by all registrants who are
subject to the requirements to submit a pertinent item of data, or a
cost-sharing agreement between 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 not to suspend the registration of a
product when a registrant fails to submit data required under F1FBA
Section 3(c)(2)(B). EPA has concluded that it is appropriate to exercise
its discretion not to suspend in ways which will discourage duplicative
testing. Accordingly, if: (1) a registrant has informed us of his
intent to develop and submit data required by this Notice; and (2) a
second registrant informs EPA that it has made a bona fide offer to the
first registrant to share in the expenses of the testing [on terms to be
agreed upon or determined by arbitration under PIPEA Section
3(c)(2)(B)(iii)] and (3) the first registrant has declined to agree to
enter into a cost-sharing agreement, EPA will not suspend the second
firm's registration. While the first firm is not required to agree to
jointly develop data EPA La not required to force the second firm to
engage in economically inefficient duplicative testing in order to
maintain its registration.
10
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5. Request that EPA amend your registration by deleting the uses
for which the data are needed.
6. Bequest voluntary cancellation of the registration(s) of your
products for which the data are needed.
E. Procedures for Requesting Changes In Testing Methodology and
Extensions of Time
EPA recognizes that you may disagree with our conclusions regarding
the appropriate ways to develop the required data or how quickly the
data must be submitted.
If the test procedures you plan to use deviate from (or are not
specified in ) 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 want, or think that you will need, more time to generate the
required data than is allowed by EPA's schedule, you may submit a
request for an extension of time. The extension request must be
submitted in writing to the Product Manager. The extension request
should state the reasons why you conclude that an extension is
appropriate. You must strive to meet the deadline for submitting the
required data while EPA considers your request.
11
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0,0,0,0-TETRAPROPYL DITHIOPYROPHOSPHATE
(ASPONR)
-------
GENERIC DATA REQUIREMENTS FOR MANUFACTURING-USE AND END-USE PRODUCTS NOT EXEMPTED BY FIFRA SECTION 3(c)(2)(D)
TABLE A
GUIDELINES
CITATION
63.62-7(b)
-7(c)
63.62-B(b)
63.62-fl(f)(2)
-B(f)(3)
-8
63.62-9(6)
-9(d)
63.62-lO(b)
63.62-ll(d)
test on Typical f
NAME OP TEST
Hydrolysis
Photodegradation
Aerobic soil metabolism
Effacci of microbes on peaticide
Effects of pesticides on microbe
Activated sludge metabolism
Leaching
Adaorpt ion/desorpt ion
Terrestrial field dissipation*
Fish accumulation
rmulated Product
USE PATTERN
Non-Domes tic /Domes! ic, Out door,
Non-food
it
it
it
ii
ii
ii
ii
ii
ii
MUST APPLICANT
ACKNOWLEDGE RELIANCE
UNDER FIFRA J3(c)(l)(D)
No
ii
ii
n
ii
n
ii
ii
ii
ii
BIBLIOGRAPHIC
CITATION
MUST DATA BE
SUBMITTED UNDER
FIFRA S3(c)(2)(B)
Yes
ii
ii
ii
ii
ii
•i
ii
ii
ii
MONTHS
ALLOWED
IIEFORE
sun -
MISSION
24
24
24
24
24
24
24
24
24
24
0,0,0,0- TETRAPROPYL DITHIOPYROPHOSPHATE (ASPONR!
-------
TABLE A Cont'd.
GENERIC DATA REQUIREMENTS FOR MANUFACTURING-USE AMD EMU-USE PRODUCTS HOT EXEMPTED BY FIFRA SECTION 3(c)(2)(D)
GUIDELINES
CITATION
163. 81-1
-2
-3
-7
163. 83-3
163.71-1
163.72-1
* Required on Techi
NAME OF TEST
Acute oral toxicity
Acute dermal toxicity*
Acute inhalation toxicity
Acute delayed neurotoxicity
Toratogenicity
Avian aingle-doae LDjo*
Acute toxicity to eatuarine and
marine organiame*
ical Product
USE PATTERN
Non-domeat ic/Domest ic .Outdoor ,
Non-food
it
ii
ii
ii
•i
ii
MUST APPLICANT
ACKNOWLEDGE RELIANCE
UNDER FIFRA |3(c)(l)(D)
No
ii
ii
•i
ii
"
BIBLIOGRAPHIC
CITATION
MUST DATA BE
SUDHITTED UNDER
FIFRA !3(c)(2)(B)
Yea
II
II
II
»
•i
•i
MOUTHS
ALLOWED
BEFORE
sun-
Miss ION
6
6
6
24
2
-------
opu
ICTS
i
Table B
Guiuel Ine
Citation
163.61-3
-4
-5
-6
-7
163.61-8(1)
-8(2)
-8(3)
-8(4)
-8(5)
-8(6)
-8(7)
• Any imputti
Name o£ Test
Product Identity and dio-
closure of Ingredients
Description of manufactur-
ing process
Discussion on formation of
unintentional Ingredients .
Declaration and certifica-
tion of ingredient limits
Product analytical methods
and data
Color (Technical)
Odor (Technical)
Melting Point (Technical)
Solubility (Technical)
Stability (Technical)
Octanol/water partition
coefficient (Technical)
Physical State (Manufactur-
ing-use Product and the
Technical)
tlea at O.lt or less-Informa
Composition Characteristics
Any percentage active
ingredient
•
•
•
N
H
H
•
•
H
N
N
.ion need not be submitted unli
Does EPA Have Data
To Satisfy This
Requirement?
NO
H
PI
N
•
H
•
•
N
•
N
•
i 24 mos.
Biblio-
graphic
Citation
Must Data De
Submit Led
Under FIFRA §
3(c) (2} (B) ?
Yes
N
H
N
H
•
M
•
H
H
•
N
Months
Al lowed
Before
Submission
6
14
24
6(24mos.*)
6
6
6
6
6
6
6
6
0,0,0,0-TETRAPROPYL DITHIOPYROPHOSPHATE (ASPON )
-------
PRODUCT-SPECIFIC DATA REQUIREMENTS FOH MANUFACTURING-USE PRODUCTS
fable- B Cont'd
Guideline
Citation
-8(0)
-8(9)
-8(10)
-B(ll)
-B(12)
-8(13)
-8(14)
-8(15)
-8(17)
-8(18)
Name of Test
Density or specific gravity
(Manufacturing-use Product
and the Technical)
Boiling Point (Manufactur-
ing-use Product and the
Technical)
Vapor pressure (Manufsctur-
Ing-uae Product and the
Technical)
pH (Manufacturing-use Pro-
duct and the Technical)
Storage Stability
Flammabillty
Oxidizing or reducing
action
Exploslvenesc
Viscosity
Corrosion characteristics
Composition Characteristics
Any percentage active
ingredient
M
«
II
N
H
N
N
M
•
Does EPA Have Data
To Satisfy This
Requirement?
No
M
•
M
•
M
M
N
•
•
Biblio-
graphic
Citation
riust Data Be
Submitted
Under TIFRA 5
3(0(2)10) ?
Yes
M
N
N
H
H
•
M
M
H
Months
Allowed
Before
Submission
r.
6
6
6
6
6
6
6
6
6
0,0,0,0-TETRAPROPYL DITHIOPYROPHOSFHUTE (ASPONR)
-------
"T
_: _ \
PRODUCT-SPECIFIC PATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
Tcible' B ContM.
Guide)ine
Citation
Name oC Test
Composition Characteristics
noes EPA Cave Data
To Satisfy This
Requirement?
Biblio-
graphic
Citction
llust Data Be
Submitted
Under FITRA 5
3(c)(2)(D) ?
MonLhs
Allowed
Before
Submi ssion
163.C1-1
-2
-3
-4
-5
-6
Acute oral toxicity
Acute dermal toxicity
Acute Inhalation toxicity
Primary eye Irritation
Primary dermal irritation
Dermal oenoltization
Any percentage active
ingredient
No
Yes
0,0,0,0-TETRAPROPYL DITHIOPYfiOPHOSPHATE (ASPON
R,
-------
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS
Table C
Guidel Ine
Citation
163.61-3
-4
-5
-6
-7
163.61-6(1)
^ro —
-8(8)
-8(12)
-8(13)
^inT
-------
C Cont'd.
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS
Guidelines
Citation
; -8(17)
-8(18)
-8(19)
Name of Test
Viscosity
Corrosion characteristics
Dielectric breakdown
voltage
Composition Characteristics
All EC Products
All EC Products
Granular Products
All EC Products
Does EPA Have Data
To Satisfy This
Requirement ?
No
II
n
tl
Biblio-
graphic
Citation
Must Data Be
Submitted Undet
FIFRA 5
3
-------
Tar
Guideline
Citation
163.81-1
163.81-2
163.81-3
163.81-4
163.81-5
i** Ttit on for
Name ot Teat
Acute Oral Toxicity •*•
Acute Dermal Toxicity •••
Acute Inhalation
Toxicity •••
Primary Eye Irritation •••
Primary Dermal
Irritation •••
aultttd product as described on pg^
Composition Characteristics
EC's between 12% and 28% a.i.
EC's between 65% and 68% a.i.
EC's with Aspon and other
active ingredients
3ranulars between 1% and 6%
EC's between 12% and 28% a.i.
EC's between 65% and 68% a.i.
EC's with Aspon and other
active ingredients
Zranulars between 1% and 6%
EC's between 12% and 28% a.i.
EC's between 65% and 68% a.i.
EC's with Aspon and other
active ingredients
Granulars between 1% and 6%
EC's between 12% and 28% a.i.
EC's between 65% and 68% a.i.
EC's with Aspon and other
active ingredients
Granulars between 1% and 6%
EC's between 12% and 28% a.i.
EC 'a between 65% and 68% a.i.
EC's with Aspon and other
active ingredients
Granulars between 1% and 6%
r 20 of tha Registration Standard.
Does EPA Have Data
To Satisfy This
Requirement ?
No
No
No
Yes
Yes
No
No
Yes
No
No
NO
NO
Yea
No
•
No
Yes
Yes
No
No
Yes
Biblio-
graphic
Citation
000004857
000004838
000004B5B
000004833
or 000004836
or 000004835
000004861
000004837
000004859
Hust Data Be
Submitted
Under F1FRA $
3(c)(2)(B) ?
Yes
Yes
Yes
No
No
Yes
Yes
No
Yes
Yes
Yes
Yes
No
Yea
Yes
No
No
Yea
Yea
No
Months
Allowed
Before
Sub-
mission
6
6
6
6
6
6
6
6
6
6 i
6
6 i
i
6
6
6
6
6
6
6
6
0,0,0,0-TETRAPROPYL DITHIOPYROPHOSPHATE (ASPON )
-------
4-aminopyridine
(AvitrolR)
-------
Table A GENERIC DATA REQUIUEMENTS FOR MANUFACTURING-USE AND END-USE PRODUCTS NOT EXEMPTED BY F.I.F.R.A.
Section 3(c)(2)(D).
GUIDELINES SECTION
163.62-8(b)
163.62-9
163.71-1
163.71-2
163.71-4
163.72-1
163.71-5(1)
NAME OP TEST
Environmental
Chemistry
Aerobic Soil
Metabolism
Leaching
Ecological Effects
Avian Single-
Dose LD5Q
Avian Dietary
LC50
Avian Reproduction
Fish Acute LC50
Cage or Pen Field
Test
USG PATTERN OR
COMPOSITION
CHARACTERISTICS
All
All
All
All
All
All
All
Mast Applicant
Acknowledge
Reliance Under
FIFRA S3(c)(l)(D)?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Bibliographic
Citation(s)*
05003185
05003185
00004001
05003186
05003101
05003186
00003998
00004083
05003191
GS -0015-004
05003186
00004083
00003999
00004101
00004083
Must Date
Be Submitted
Reliance Under
S3(c)(2)(B)7
No
NO
NO
No
No
NO
No
Months
Allowed
Before
Submission
*A11 citations must be listed where data must be acknowledged.
AVrTROLr
-------
Table A (Continued)
GO IDG LINES SECTION
163.71-5(2)
Special Test
Requirement
(See 163.70-1)
163.81-1
163.81-2
163.82-1
163.82-4
163.83-3
NAME OF TEST
Pull Scale field
Secondary
Poisoning
Toxicology
Acute Oral
Toxic ity
Acute Dermal
Toxic ity
Subchronlc Oral
Toxic ity
Subchronic
Inhalation
Requirements
Tecatoyenicity
USB PATTERN OR
COMPOSITION
CHARACTERISTICS
All Formulations
All Formulations
All
All
All
Dusts without
Protective Clothing
Requirements
All Other
Formulation a
Duets without
Protective Clothing
Requirements
All Other
Formulations
Must Applicant
Acknowledge
Reliance Under
FIFRA S3{C)(1)
-------
Table A (Continued)
GUIDELINES SECTION
163.83-1,2,3,4
None
None
NAME OF TEST
Mutagencity
Residue Chemistry
Plant Metabolism
Analytical Method
for Determining
Residues in Crops
USB PATTERN OR
COMPOSITION
CHARACTER 1ST ICS
Dusts without
Protective Clothing
Requirements
All Other
Formulations
Non-Crop
Corn
Sunflowers
Corn and
Sunflowers
Sunflowers
(only)
Non-Crop
Must Applicant
Acknowledge
Reliance Under
FIFRA S3(c)(l)(D)?
No
No
No
Yes
Yes
Yes
Yes
No
Bibliographic
Citation(s)*
05003202
00004039
00004088
05003193
00004030
00004016
00004007
00004126
00004011
00004029
00004050
00004048
05003192
Must Date
Be Submitted
Reliance Under
S3(c)(2)(B)?
No
No
No
No
No
NO
NO
No
Months
Al lowed
Before
Submission
24
*A11 citations must be listed where data must be acknowledged.
AVTTROI/
-------
Table A (Continued)
GUIDELINES SECTION
None
NAME OF TEST
Residue Chemistry
(Continued)
Residue Data
USE PATTERN OR
COMPOSITION
CHARACTERISTICS
Corn
Sunflowers
Non-Crop
Must Applicant
Acknowledge
Reliance Under
PIFRA S3(c)(l|(D)?
Yes
Yes
NO
Bibliographic
Citation! s)*
00003993
00004017
00004022
00004089
Must Date
Be Submitted
Reliance Under
S3(c)(2)(Bl?
No
No
No
Months
Allowed
Before
Submission
"All citations must be listed where data Must be acknowledged.
AVTTRQIT
-------
Table B PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS
GUIDELINES
SECTION
163.61-3
163.61-4
163.61-5
163.61-6
163.61-7
NAME OF TEST
Product Chemistry
Product Identity
and Disclosure
of Ingredients
Description oE
Manufacturing
Processes
Formation of
Ingredients
Certification of
Ingredient Limits
Product Analytical
Methods Data
COMPOSITION
CHARACTER 1ST ICS
Technical and
other Manufacturing
Use Formulations
Technical and
other Manufacturing
Use Formulations
Technical and
other Manufacturing
Use Formulations
Techn ical and
other Manufacturing
Use Formulations
Technical
Other Manufacturing
Use Formulations
Does EPA nave
Data to Satisfy
This Requirement?
No
No
NO
NO
No
Yes
Bibliographic
Citation! a)
05010341
05006161
[Active ingredient
only)
00004112
Must Date
Be Submitted
Under FIFRA
S3(c)(2)(B)?
Yes
Yes
Yes
Yes
Yes
NO
Monthf
Allowed
Before
Submission
6
24
24
6 (24)*
6
6
*24 months permitted for submission of information on impurities present as less than 0.14 of total product.
information on impurities present at greater concentrations will be submitted within 6 months.
-------
Table B (Continued)
ill IDE LINKS
SECTION
163.61-8(1 )
163.61-8(2)
163.61-8(3)
163.61-8(4)
163.61-8(5)
163.61-8(6)
NAME OF TEST
Color
Odor
Melting Point
Solubility
Stability
Octa no I/Water
Partition Co-
efficient
COMPOSITION
CHARACTERISTICS
Technical
Other Manufacturing
Use Formulations
Technical
Other Manufacturing
Use Formulations
Technical
Othec Manufacturing
Use Formulations
Technical
Technical
Technical
Does EPA Have
Data to Satisfy
This Requirement?
Yes
No
Yes
No
Yes
Ho
No
Yes
No
Bibl lographic
CUation(a)
00004112
00004019
00004112
00004019
00004112
00004019
00004112
00004019
Must Date
Be Submitted
Under FIFHA
53(c)(2)(B)7
No
Yes
NO
Yes
No
Yes
Yes
Ho
Yes
Month.'.
Allowed
Before
Submission
6
6
6
6
6
6
6
6
6
AVTTROLR
-------
Table B (Continued)
GUIDELINES
SECTION
163.61-8(7)
163.61-8(8)
163.61-8(9)
163.61-8(11)
163.81-1
163.81-2
163.81-4
163.81-5
NAME OF TEST
Physical Sbabe
Density or Specific
Gravity
Boiling Point
pll
Toxicology
Acute Oral
Tox ic 1 ty
Acute Dermal
formulations
Primary Eye
Irritation
Primary Dermal
Irritation
COMPOSITION
CHARACTERISTICS
Technical and other
Manufacturing Use
Formulations
Technical and other
Manufacturing Use
Formulations
Technical
Technical
Non- technical
Formulations
Non- technical
Nan- technical
Non-technical
p
Does EPA Have
Data to Satisfy
This Requirement?
Ves
No
Yes
No
Yes
Yes
Yes
Yea
Bibl iographic
Citation(s)
00004112
00004019
00004019
00004112
00004024
00004024
00004024
00004024
Must Date
Be Submitted
Under FIFRA
53(c)(2)(DJ?
No
Yes
Ho
lea
NO
NO
No
NO
Months
Allowed
Before
Submission
6
6
6
6
6
6
6
6
AVTTRQL
-------
Table C PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS
GUIDELINES SECTION
163.61-3
163.61-4
163.61-5
163.61-6
163.61-7
163.61-8(1)
NAME OP TEST
Product Chemistry
Product Identity
and Disclosure
of Ingredients
Description of
Manufacturing
Processes
Formulation of
Unintentional
Ingredients
Description and
Certification of
Ingredient Limits
Product Analytical
Methods/Data
Color
COMPOSITION
CHARACTERISTICS
All Formulations
All Formulations
All Formulations
All Formulations
All impregnated
grains
Other Formulations
On Technical
On Formulations
Must Applicant
Acknowledge
Reliance Under
FIFRA §3(c)(l)(D)7
No
No
No
No
Yes
No
Yes
No
Ribliographi'c
Citation(s)
00003978 and
00004020
00004019 and
00004112
Must Date
Be Submitted
Reliance Under
S3(c)(2)(B)7
Yes
Yes
Yes
Yes
NO
Yes
No
Yes
Months
Allowed
Before
Submission
6
24
24
6 (24)*
6
6
6
6
*24 months permitted for submission of information on impurities present as less than 0.1% o£ total product.
Information on impurities present at greater concentrations mast be submitted within 6 months.
AVTTROL
R
-------
Table C (Continued)
DEMNES SECTION
3.61-8(2)
.61-8(7)
.61-6(8)
.61-8(9)
.61-8(11)
.61-8(12)
.81-1
NAME OF TEST
Odor
Physical State
Density/Specific
Gravity
Boiling Point
PH
Storage Stability
Toxicology
Acute Oral
Toxic ity
COMPOSITION
CHARACTERISTICS
On Technical
On Formulations
On Technical
On Formulations
On Formulations
On Technical
On Technical
All Formulations
All Formulations
Must Applicant
Acknowledge
Reliance Under
FIFRA S3(c)(l)(D)7
Yes
NO
Yes
NO
NO
No
NO
NO
Yes
Bibliographic
Cltatlon(e)
00004019 and
00004112
00004019 and
004112
00004019 and
00004112
00004024
Husk Date
Be Submitted
Reliance Under
S3(c)(2)(B>?
No
Yes
No
Yes
Yes
No
Yes
Yes
NO
Months
Allowed
Before
Submission
6
6
6
6
6
6
6
6
6
AVTTRQL
R
-------
Table C (Continued)
GUIDELINES SECTION
163.81-3
163.81-5
163.82-4
NAME OF TEST
Acute Inhalation
Primary Dermal
Subch ironic
Inhalation
TOK Ic i ty
COMPOSITION
CHARACTERISTICS
Dust Formulations
Non-Dust Formulations
Granular ( Impregnated
Grain) Formulations
Non-Granular
Formulations
Dusts without
Protective Clothing
Requirements
All Other
Formulations
Must Applicant
Acknowledge
Rel iance Under
FIFRA S3(cHl)(D)?
Yes
No
Yes
No
No
NO
Bibliographic
Citation(s)
00004137 and
00004024
Must Date
Be Submitted
Reliance Under
S3(c)(2)(B)7
Yes
No
NO
No
Yes
No
Months
Allowed
Befoce
Submission
24
6
24
AVITROL'
-------
l,4-Dichloro-2,5 Dimethoxybenzene
(Chloroneb)
-------
TABLB-A
GENERIC DATA REQUIREMENTS FOR MANUFACTURING-USE AND END-USE PRODUCTS NOT EXEMPTED BY FIFHA SECTION 3(c)(2)(D)
Guideline* Section Naae of Test Use Pattern
163.81-1
163.81-2
163.81-3
163.82-1
163.82-2
163.83-1
163.83-2
163.83-3
163.83-4
163.84-1
163.83-1
Acute Oral Toxlclty
Acute Derail Toxlclty
Acute Inhalation
Toxlclty
Subchronlc Orel Dosing
Subchronlc 21-day
Oeraial ToMlclty
Chronic loading
Oncogenlcl ty
Tecetagenlclcy
Reproduction
Mutegenlclty
Metabollaa
food
turf
food
turf
food
turf
food
food
turf
food
food
food
turf
food
turf
food
turf
food
Hust Applicant Bibliographic
Acknowledge Reliance Citation
under P1VRA 3(c)(l)(D)l
ye*
yea
no
no
no
no
yes-
yea
ye*
ye*
ye*
no
no
no
no
no
no
yu*
CS0007-010
00001446 •
00001421 t
00004980
0000144S
00001445
00001422
00001422
U3001D9 6
00001424
Must Data be
SubBltted
under FIFRA
3(c)(2)(B)T
no
ao
ye*
ye*
ye*
ye*
no
no
no
yea
ye*
ye*
ye*
ye*
ye*
ye*
ye*
ye*
Honth* Allowed
Before
Subal s* Ion
6
6
6
24
24
42
42
24
24
24
24
CHLORONEB
-------
Pag* 2 TABLE-A
GENERIC DATA REQUIREMENTS FOR MANUFACTURING-USE AND END-USE PRODUCTS NOT EXEMPTED BY FIFRA SECTION 3(c)(2)(0)
Guidelines Section Name of Teat Uee Pattern
163
163
163
163
163
163
163
163
163
163
.62-7(b)
.62-7
-------
Page 3
TABLB-A
GENERIC DATA REQUIREMENTS FOR MANUFACTURING-USE AND END-USE PRODUCTS NOT EXEMPTED BY FIPRA SECTION 3(c)(2)(D)
Guidelines Section
16J.62-ll(b)
163.62-ll(d)
163.71-1
163.71-2
163.72-1
163.72-2
Name of Teat
Rotational Crop
Flah Accumulation
Avian Single Dose
Oral LD SO ** (•)
Avian Dietary LC 50
Mallard Duck 6
Bobwhlte Quail ** (a)
Flah Acute LC 50
Rainbow Trout 4
Blueglll ** (a)
Acute Toxlclty to
Aquatic Invertebrates
Use Pattern
food
food
turf
food
turf
food
turf
food
turf
food
turf
Muat Applicant
Acknowledge Reliance
under FIFRA 3(c)(l)(D)7
no
no
no
no
no
yes
yea
yea
yea
yea
yea
Bibliographic Must Data be
Citation Subnltted
under FIFRA
3(c)(2)(B)?
yes
yes
yes
yes
yes
CS00007-001 & no
GS00007-002 no
CS0007-003 yes
yes
CS00007-OOS no
no
Months Allowed
Before
Submission
24
24
6
6
6
6
** (a) Required on Technical Product
CHLORONEB
-------
TABLE-B
PRODUCT-SPECIFIC DATA RBQUIHEHENTS FOB MANUPACTURINC-USB PRODUCTS
Months Allowed
Before
Submission
Guidelines Section Name oE Test
163.61-6 *
163.61-7
Composition Does EPA Have Data
Type to Satisfy this
RequlreoentI
Bibliographic Must Data be
Citation Submitted
under FIPRA
3(c)(2)(B)7
163.
163.
163.
61-3
61-4
61-5
Product Identity &
Disclosure of Ingrdl«nta
Description of
Manufacturing Process
Discussion on Forastlon
Hanufaetur- yes
Ing Use
Product
no
no
GS00001428 no 6
yea 24
yes 24
of Unintentional
Ingredients
Declaration *
Certification of
Ingredient Limits
Product Analytical
Methods i Oats
yes
yes
163.61-8(1)
163.61-8(2)
163.61-8(3)
163.61-8(4)
163.61-8(5)
163.61-8(6)
Color Technical
Product
Odor
Melting Point
Solubility
Stability
Octanal/Hater Partition
yes
yea
yea
yea
yes
no
00001444
00001444
00001444
00001444
00001444
no
no
no
no
no
yee
6
6
6
6
6
6
Coefficient
CHLORONEB
-------
Page 2
TABLB-B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
Guidelines Section Name of Teat
163.61-8(7)
163.61-8(8)
163.61-8(9)
163.61-8(10)
163.61-8(11)
163.61-8(12)
163.61-8(13)
163.61-8(14)
163.61-8(15)
163.61-8(18)
Physical State
Density or Specific
Boiling Point
Vapor Pressure
P«
Storage Stability
Flaooablllty
Oxdlclng or
Reducing Action
Exploit Iveneea
Corroalon
Composition Dcea EPA Have Data Bibliographic Must Data be
Type to Satisfy this Citation Submitted
Requirement? under F1FRA
3(c){2)(B)7
Technical yes
& Hanuf acturlng
Use Product
ye.
yes
yes
yee
Manufacturing no
Use Product
" "no
"no
no
no
00001444 so
00001444 no
00001444 no
00001444 no
00001444 no
yee
yes
yes
yea
yea
Hontha Allowed
Before
Submission
6
6
6
6
6
6
6
6
6
6
163.81-1
163.81-2
Characteristics
Acute Oral Toxiclty
Acute Dermal
Toxiclty
Manufacturing yes
Use Product
no
GSO007-010
yes
CHLORONEB
-------
Page
TABLE-B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
Composition Does EPA Have Data Bibliographic HusC Data be Months Allowed
Type to Satisfy this Citation Submitted Before
Requirement? under FIPRA Submission
3(c)(2)(B)7
Guidelines Section Name of Test
163.81-3
163.81-4
163.81-5
Acute Inhalation
Toxlclty
Primary Eye Irritation
Primary Dermal
Manufacturing
Uae Product
-
W N
no
yea
y«a
no 6
GS0007-011 no 6
CS0007-012 no 6
Irritation
163.81-6 Dermal SensltIzatlon " "no
* Any information on ImpurIt lea of leaa that 0.1X need not be submitted for 24 months,
yea
CHLORONEB
-------
TABLB-C
PRODUCT-SPECIFIC DATA REQUIREMENTS FOE END USB PBODUCTS
Guidelines Section Name of Teat
163.61-3
163.61-4
163.61-5
163.61-6 *
163.61-7
163.61-6(1)
Product Identity ft
Disclosure of
Ingredient
Description of
Manufacturing Process
Discussion of
Fornatlon of
Unintentional
Ingredients
Declaration &
Certification of
of Ingredient Llalta
Product Analytical
Methods and Data
Color (a)
Cooposltlon Does EPA Have Data Bibliographic Must Data be Months Allowed
Character- to Satisfy this Citation Submitted Before
Istlca Requirement! under FIFRA Submission
3?
Wettsble no
Vowder
granular "
dust
Wettsble no
Powder
granular "
dust
Uettable no
Powder
granular "
dust
Uettable no
Fonder
granular
dust
Wettable no
Powder
granular
duet
Wettable no
Powder
granular
dust
yes 6
yes 24
yea 24
yes 6
yea 6
yes 6
CHLORONEB
-------
Page 2
TABLB-C
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR END USE PRODUCTS
Guidelines Section Name of Teat Composition Does EPA Have Data Bibliographic Muat Data be Months Allowed
Character- to Satisfy this Citation Submitted Before
latlca Requirement? under PIFRA Submission
3(c)(2)(B)T
163.61-8(2)
163.61-8(7)
163.61-8(8)
163.61-8(9)
163.61-8(10)
163.61-8(1 1)
Odor (a) Wettable no
Powder
granular "
duat
Physical State (a) Wettable yea
Powder
granular "
duat
Density or Specific Wettable no
Gravity (a) Powder
granular
duat
Boiling Point (a) Wettable yea
Powder
granular
duat
Vapor Pressure (a) Wettable yea
Powder
granular "
duat
pH (a) Wettable no
Powder
granular
dust
yea 6
00001444 no 6
yea 6
00001444 no 6
00001444 no 6
yes 6
CHLORONEB
-------
Page 3
TABLB-C
PRODUCT-SPECIFIC DATA REQUIREMENTS FOB MANUFACTURING-USE PRODUCTS
Guidelines Section Name of Teat Compos it ion Doe a EPA Have Data Bibliographic Hunt Data be Months Allowed
Character- to Satisfy thla Citation Submitted Before
latlca Requirement? under FIPBA Subolaalon
3(c)(2)(B)l
163.61-8(12)
163.61-8(13)
163.61-8(14)
163.61-8(15)
163.61-8(16)
163.61-8(17)
Storage Stability Uettable no
Powder
granular
duat
Flaaoablllty Uettable no
Powder
granular
duat
Oxidizing or Reducing Uettable no
Action Powder
granular
duat
Bxploalveneaa Uettable no
Powder
granular
duat
Mlaclblllty Uettable no
Powder
granular
duat
Vlacoalty Uettable no
Powder
granular
duat
yea 6
yea 6
yea 6
yea 6
yea 6
yea 6
CHLORONEB
-------
rage 4
TABLE-C
PRODUCT-SPBCIPIC DATA REQUIREMENTS FOR BHO USE PRODUCTS
Guidelines Section Name of Teat Composition Does EPA Have Data Bibliographic Kust Data be
Character- to Satisfy thin Citation Submitted
latlca Requirement? under FIPRA
3{c)<2)(B)7
163.61-8(18)
163.81-1
163.81-2
163.81-3
163.81-4
Corroalon Wettable
Characterlatlca Powder
granular
duat
Acute Oral Toxlclty 10X duat
6.25-10X
granular
6SZ Wettable
Powder
Acute Dermal Toxlclty 10% duat
6.25-101
granular
65X Wettable
Powder
Acute Inhalation 10X duat
Toxlclty 6.25-10Z
granular
651 Wettable
Powder
Primary Bye Irritation 10X duat
6.25-10Z
granular
65X Hettable
Powder
no
m
m
no
yea
ao
no
no
no
no
no
no
no
no
no
yea
yea
OOOOU9S no
yea
yea
yea
yea
yea
yea
yea
yea
yea
yea
Months Allowed
Before
Submission
6
6
6
6
6
CHLORONEB
-------
Page 5
TABLE-C
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR END USE PRODUCTS
Months Allowed
Before
Submission
Guidelines Section Name of Teat
CompositionDoes EPA Have Data
Character- to Satisfy this
Istlcs Requirement?
Bibliographic Huet Data be
Citation Submitted
under FIFRA
3(c)(2)(B)T
163.81-5
163.81-6
Primary Dermal
Irritation
Dermal
Senslt Izatlon
10Z dust
6.2S-10Z
granular
6SZ Hettable
Powder
10Z dust
6.2S-10Z
granular
6SZ Wectable
Powder
.no
yea
no
no
no
no
yea
00001495 no
yea
yea
yea
yea
6
6
* Any Information on impurities of less than 0.1Z need not be aubmltted for 24 months.
(a) Required of both the formulated and the technical product.
CHLORONEB
-------
2-chloro-N-{2-ethyl-6-methylphenyl)
-N-(2-methoxy-l-methylethyl) acetamide
(Metolachlor)
-------
GCNFRIC DATA REQUIREMENTS mil HANIirAnilRING-IISr AND INI)-Ur.r I'KUUIICIS Ndf CXCMIMCU HY riFKA f.r.f.MON l(r)(Z)(l>)
Table A
Gill del inc
C Hal ion
I63.f»2-7(h)
-7{c)
163.G2-B(b)
-n(c)
!63.62-n(f)(2)
-fl(f)(3)
-0(9)
163.62-9(1))
-9(.l)
lG3.62-IO(b)
163.62-11(1))
-M(d)
Name of Test
Hydrolysis
Photodecjradation
Aerobic soil mnl nbolism
Anaerobic soil metabolism
Effects of microbes on pesticide'
Effects of pesticides on microbe'
Activated sludge metabolism
Leaching
Adsorpl Ion/
-------
GCNCRIC DrtIA REQUIREMENTS I" OR MANIirACIIIRINO-USr AND END-USE PRODI/CIS NO I EXEMI'IEII ItY FIFRA SI'Cl KIN 1(c)(?)(l))
Tabla A
Guide 1 inns
C Hat ion
163.71-1
-2
-4
163.7?-!
-2
-/I
Name of Test
Avion single-dose oral Ll)r,g
Avian dietary (.050 mallard
bobwh i 1 c
qn.ii 1
Avian rpproilucl ion mallard
and
bobwli i 1 e
Fish acute LCjn, rainbow
trout
and
blucgill
Acute tox icily to aquatic
Invertebrates
Embryo! arvae and life cycle
studies/fish and aquatic
vertebrates
Use I'al lorn
Atjr icul tral -corn sor'jhnm peanuts.
soybeans
ii
ii
ti
ii
•I
••
Must Appl iranl
Ai.knowlcdge Reliance
Under FIFRA §3(c)(l)(D)
Cite Data in Standard's
Rlhl inqriipliy
No
YPS
Yes
Yes
Yes
Yes
Yes
Yes
•
Yes
Ilibl ioyr.iphic
Citation
Must Data Bo
Submitter! Under
PIKRA §3(c)(2)(U)
Yci
No
Nn
No
Nil
No
No
No
No
Mori Mis
A! lownd
Urforc
Still -
IIUJLSJQQ
r>
MF.TOLACHOR
-------
GENERIC DATA REQUIREMENTS FOR MAHUFACIIIKING-USr. AMI) END-USE PIIOIHIUS NOF EXEMPTED BY FITRA SECTION 3(c)(?)(fl)
Table A
Guide) ines
Citation
163.81-1
-2
-3
163.02-1
-?.
163.03-1
-2
-3
-1
163.01-1
163.85-1
Name? of Test
Acute oral tox icily
Acute (Irrmal tox Icily
Acute inhalation toxicity
Subclironlc oral dosing
Evalual Ion for rat pathology
study
Suhchronlr 21 -day dermal toxicil}
Chronic feeding
Oncogenlcity, mouse and rat
study completed
2nd study other than mouse
2nd study In mouse in progress
fora togen icily
(1st species completed)
2nd species in progress
Rcprodiicl Inn
Completed study
2nd study in progress
Mutacjenlcity
Metabolism
USP Pattern
Agr icul turn 1 -rorn, sorghum peanuts,
soybeans
••
-
*i
••
II
»
II
II
II
II
»
it
n
n
Must Appl icaul
Acknowledge Rel iance
Under FIFRA r,3(c)(l)(D)
Cite Data in Standard's
Oibl iography
Yes
Yes-
Yes
Yes
No
YPS
No
Yes
No
No
Yes
No
Yes
No
Yes
Yes
libl iograplnc
Citation
Must Data Itr
Submit ted Under
FIFRA ^l(c)(2)(B)
No
No
No
No
YPS
No
Yes
No
Yes
Yes
No
YPS
No
Yes
No
No
Mon His
A 1 1 owpd
Bpfore
Siih-
miss ion
21
9/I/03
12
H/1/II2
1 1 /I/HO
fi/l/n?
METOLACHOR
-------
I'ROUUCT-SPKCIKIC SPKCIKIC DATA HIIOHI KI.MUHTH HW MAIIIirAlTIIK IMC IJ!JK I'llODIIl. TS
Table
GuirleJ i ne
Citation
163.6J-3
-1
-5
-6
-7
163.61-0(1)
-0(4)
-8(5)
-8(6)
-0(7)
Name of Test
Product Identity and dis-
closure of Ingredients
Description of manufactur-
ing process
Discussion on formation of
unintentional ingredients
Declaration and certifica-
tion of ingredient limits
Product analytical methods
and data
Color
Odor
Goliibll ity
StaLill Ity
Octanol/water partition
coefficient
Physical State
Compos) I ion Chai nctor i Rl-ics
Technical
lloos TPA ll.iuo llntn
To Sali sfy This
Requ i romcnt?
Yen
Ilihlio-
qcaphic
CiL.it Ion
NO
Yen
Hull: On I n KG
Submi ttorl
Under 1'ITRA '
3(c) (2) (ID ?
No
Yes
Mo
non11 m
Al lct'C'1
Uofoie
Snb-
fi month5!
METOLACHOR
-------
pnoDHCT-spnciFic: SPECIFIC DATA Rr.omRRnr.HTS FOH MANUFACTURIHG-IIKR PRODUCTS
Table b con I. "d
Gu I del ine
Citation
-0(8)
-0(9)
-8(10)
-0(12)
-JM13)
-0(14)
-0(15)
-0(17)
-0(18)
Name of Ted-
Deris ity or speciCic gravity
Dolling Point
Vapor pressure
Storage Stability
riammabJ 11 ty
Oxidizing or reducing
nc 1 1 on
r.xpVos Iveneos
ViGcosi ty
Corrosion characteristics
Compos i t Ion Chaiacter i it ics
Technical
it
n
-
••
n
ii
n
Does EPA Have Data
To Satisfy This
Requi rement?
Yes
"
11
n
No
II
11
II
II
nibl io-
qtaphicj
Citation
Mint Dntn He
Submi 1- Led
llncloi nrUA a.
No
11
ii
if
Yes
Ii
n
"
fi
rinnl hs
Al Uiwcil
Drforr;
fl RIOS .
6 mor. .
fi raon .
C moi .
6 mo^;.
METOLACHOR
-------
PKODUCT-SPECIMC HPHCII'IC DATA RHQIII RKMMNTS I'DR MANIII-'ACI'dR I tlfi-UHF. IPROMtlCTS
Tahle I) c:onl. 'cl
Gu irloi i no
Ci (.ation
Name of Tp"?t
Composition Ch.irnctor inl ics
Does HPA Have Data
To Satisfy This
Rc<|iii reincnt?
lljbl io-
graphic
C i tat Ion
Hunt
finbmi ttcrl
tlnclor I'lPKA '
3(c)(2)(B) ?
Mont In
AJ lov/Rcl
Before
T.uli-
mj SGI on
163.01-1
-2
-3
-4
-5
-6
Acute oral toxicily *
Acute dermal toxicity *
Acute inhalation toxicity *
Primary eyo irritation *
Primary dermal irritation *
Dermal sensitization *
Toclin ica I
Yoo
No
I
* Test on manuCacturing-use product
METOLACHOR
-------
piioiHirr-sprnric i>/u/\ iir. inns .
-
6 nine, .
METOLACHOR
-------
pRoniici-si'cririr n/\rA R[qiunr.HiNis nm CND-USC PROIKICIS
Table r conlM
Guidelines
Citation
163.. '1-1
-4
-6
W375T^B(r"
-3J2
-0(ii
-819
-0(10
-um
-8(12
-0 13
-8 11
-8 15
-fl Ii
-0 17
-A Ifi
)
)
Name of Test
Product Idcnllly and disclosure
of Inured tents
(Inscription of manufacturing
process
Declaration and certification
oT ingredient limits
Color
Odor
Physical Stale
Dons II v or specific gravity
nni) ing Point
Vapor pressure
pll
Storage stability
F 1 aimiab i 1 1 1 y
Oxidizing or reducing action
Exploslvencss
Miscibilitv
Viscosity
Torrosion characteristics
Compos Ilion Character 1st ic*
CM). C. C.
..
..
ij
II
11
II
11
II
"
ll
*'
"
Dors [PA llavn Halo To
Sal isfy This
Rcqulr onion 1 ?
Yes
•I
it
No
II
Yes
ii
11
li
"
11
Yes
11
ii
miiiio-
graphic
Citnlion
Must Data UP
Submitted Iliulor
riFRA 3
3(c)(2)(H) ?
llo
..
••
Ves
11
No
11
II
No
"
Mnnllis
Al lowi'fl
Bo f HIT
Suh-
mi$s ijm
6 mos
6 mos.
METOLACHOR
-------
ii ir DAiA HnjiiiuiMi.iiis nm CND-IISL
Table C conl'it
Guide 1 IMPS
Citation
163.IU-1
-2
-3
-1
-B
Mninn of Test
Acute oral lax icily
Acute dermal lox icily
Aciitc inhalation tox icily
Primary eye irritation
I'rimnry dermal irritalion
rnmnosil inn ("linractri-islics
0 Ib. E. C.
•'
11
u
Rons F.PA Have D.it,i to
Satisfy This
Requirements ?
Yes
11
No
Yes
'•
Ilibl io-
qraphic
Cil.it ion
Mur.l D.nln llr
Snlimil led llmlor
riniA 5
l(c)(2)(B) ->
No
"
Yes
No
11
Hnnlhs
Al Inwrrl
llr fore
Sub-
& nins.
METOLACHOR
-------
pnnniic.T-SPEC inc. DAI A itrouiucMr.Nrs ion END-IISI. I'
Tal)lc C conl M
Guide) inns
C Ha I ion
163.01-1
-2
-3
-4
-5
N.ime of Test
Acute oral tox icily
Acute dermal tox icily
Acute inhalation toxicHy
I'rimary pye irriCalion
Primary dermal irritation
Compos M ion Character Isl ics
6 Hi. E. C.
"
II
Onus LPA Have Data Tn
Satisfy lliis
Rpc|iiircmenl s ?
Yns
II
"
II
Ilihl io-
(JIMpIl iC
Cital inn
Must Data lln
Suhmi I. lod llndrr
rifRA §
3(c)(?)(B) ?
No
"
Monlh<;
A 1 1 owoil
Uoforn
Suli-
iii is', inn
METOLACHOR
-------
5-Ethoxy-3-trichloromethyl-l,2,4-thiadiazole
(Terrazole)
-------
TABLE A1
GENERIC DATA REQUIREMENTS FOR MANUFACTURING - USB AND END - USB
PRODUCTS NOT EXEMPTED BY FIFRA SECTION 3(c)(2)(D)
GUIDELINES
SECTION
163.81-1
163.81-2
163.81-3
163.82-1
163.82-2
163.83-1
163.83-2
163.83-3
Name of Test
Acute Oral
Toxlclty on
Technical
Acute Dermal
Toxlclty on
Technical
Acute Inhalation
Toxlclty on
Technical
Subchronlc Oral
Dosing
Subchronlc 21-Day
Dermal Toxlclty
Chronic Feeding
Oncogenlcl ty
Teratogenlct ty
Use Pattern
Ornamentals
& Turf
Ornamentals
& Turf
Ornamentals
i Turf
Ornamentals
& Turf
Ornamenta la
& Turf
Ornamenta Is
& Turf
Ornamentals
& Turf
Ornamentals
& Turf
Muat Applicant
Acknowledge
Reliance Under
FIFRA
i 3(c)(l)(D)
Yes
Yes
Yes
Yea
Yes
Yes
Yes
Yea
Bibliographic
Citation
00001SSS and
00001586 and
00001792
00002227
00001591
00001588 and
00001589 and
00001600 and
0000160S and
00001697
00001571
00001600
00001600
GS0009-033
Must Data be
Submitted Months Allowed
FIFRA Before
§ 3(c)(2)(B) Submission
No
No
Yes 6
Yes 24
Yea 24
Yea 42
Yes 42
Yes 24
TERRAZOLE
-------
Page - 2
GUIDELINES
SECTION
163.83-4
163.84-1
163.85-1
163.62-7(b)
163.62-8(c)
l63.62-8(b)
163.62-8(c)
163.62-8(f)(2)
163. -8(g)
163.62-9(b)
Name of Test
Reproduct Ion
Mutagenlcl ty
Metabolism
Hydrolysis
Phofcodegradation
Aerobic Soil
Metabolism
Anaerobic Soil
Metabolism
Effects of
Microbes on
Pesticides
Activated Sludge
Metabolism
Leaching
Use Pattern
Ornamentals
& Turf
Ornamenta Is
& Turf
Ornamenta la
& Turf
Ornamenta la
& Turf
Ornamentals
& Turf
Ornamentals
& Turf
Ornamentals
& Turf
Ornamentals
& Turf
Ornamentals
& Turf
Ornamentals
& Turf
Hust Applicant
Acknowledge
Reliance Under
FIFRA
§ 3(c)(l)(D)
Yea
Yea
Yes
Yea
No
Yes
Yea
Yes
Yes
Yea
Bibliographic
Citation
00001698
CS00009-32
0000097 or
00001S77 or
00001S99 or
00001601 or
05004729
000016SO or
00001652
00001657 or
00001662 or
00001664
00001657
00001567 or
00001664
GS0009-39
00001655 and
05001190
Mua t Data be
Submitted Months Allowed
FIFRA Before
§ 3(c)(2)(B) Submission
Yes 24
Yea
No
No
Yea 24
Yes 24
No
Yes 24
No
Yes 24
TERRAZOLE
-------
Page 3 - Table A
GUIDELINES
SECTION
l63.62-9(c)
163.62-9(d)
163.62-10(b)
163. 62-11(4)
163.71-1
163-72-1
163.72-1
163.72-2
Name of Test
Volatility
Adsorption/
Deaocptlon
Terrestrial Field
Dissipation
Fish Accumulation
Avian Single-dose
LD50
Avian Dietary
LC50
Flah Acute LCjg
Acute To xl city to
Aquatic Inverte-
Uae Pattern
Ornamentals
& Turf
Ornamentals
& Turf
Ornamentals
& Turf
Ornamentals
& Turf
Ornamenta Is
& Turf
Ornamentals
& Turf
Ornamentals
& Turf
Ornamentals
& Turf
Must Applicant
Acknowledge
Reliance Under
FiraA
§ KcHlMD)
Ho
Ho
Yes
Yea
lee
No
Yea
Ho
Bibliographic
Citation
00001659 or
00001660 or
00001661 or
00001763 or
00001663
00002238 and
00003276
00001703
Hue t Data be
Submitted Months Allowed
FIFRA Before
& 3{c)(2HB) Submission
Yes 24
Yea 24
Yes 24
Yes 24
No
Yes 6
No
Yes 6
btate
TERRAZOLE
-------
TABLE Bl
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
GUIDELINES
SECTION Name of Test
Composition
Characteristics
Does EPA Have
Data to
Satisfy tlila
Requirement
Bibliographic
Citation
Must Data be
Submit ted
Under FIFRA
§ 3(c)(2)(B)
Months Allowed
Before
Submission
163.61-3
163.61-4
163.61-5
163.61-6
163.61-7
Product Identity and
Disclosure of
Ingred tents
Description of Manu-
facturing Process
Discussion on Forna-
tlon of
Unintentional
Ingredients
Declaration & Certi-
fication of Ingre-
dients Limits
Product Analytical
Methods & Data
Manufacturing-Use
Product
Manufacturing-Use
Product
Manufacturing-Use
Product
Manufacturing-Use
Product
Manufacturing-Use
Product
Yea
Yes
Yes
Yes
Yes
CS0009-048
CS0009-048
CS0008-03S
CS0009-035
CS0009-04B
No
No
No
No
No
163.61-8(1 )
163.61-8(2)
163.61-8(4)
163.61-8(5)
163.61-8(6)
Color
Odor
Solubility
Stability
Octanol/water Fartl-
Technlcal
Technical
Technics 1
Technical
Technical
Yes
Yea
Yea
Yea
00001S53 and
00001556 and No
00001760
No
No
No
tlon Coefficient
Yea
No
TERRAZOLE
-------
Page 2 - Table
GUIDELINES
SECTION
163.61-8(7)
163.61-8(8)
163.61-8(9)
163.61-8(10)
163.61-8(11)
163.61-8(12)
163.61-8(13)
163.61-8(14)
Does EPA Have
Data to
Composition Satisfy this Bibliographic
Name of Test Characteristics Requirement Citation
Physical State Technical &
f ac taring
Density or Specific Technical &
Gravity fracturing
Boiling Point Technical &
f acturlng
Vapor Pressure Technical &
f acturlng
pH Technical &
f ac tur Ing
Manu-
Use Yes
Hanu-
Use
Yes
Mauu-
Use Yes
Manu-
Uae Yes
Hanu-
Use Yes
Storage Stability Manufacturing-Use
Product
Yes
Plammablllty Manufacturing-Use
Product
Yes
Oxidizing or Reductive Manufacturing-Use
Action Product
Yea
00001553 and
00001SS6 and
00001760
00001553 and
00001SS6 and
00001760
00001553 and
00001SS6 and
00001769
00002232
00001553 and
00001556 and
00001760
00001553 and
00001556 and
00001760
00001553 and
00001556 and
00001760
00001553 and
00001556 and
00001760
Must Data be
Submitted Months Allowed
Under FIFRA Before
S 3(c)(2)(B) Submission
No
No
No
No
No
No
No
No
163.61-8(15) Exploalveness
Manufacturing-Use
Product
No
Yes
TERRAZOLE
-------
Page 3 - Table B
GUIDELINES
SECTION
163.61-8(16)
163.61-8(17)
163.61-8(18)
163.81-1
163.81-2
163.81-3
163.81-4
163.81-5
163.81-6
Name of Test
Hlsclblllty
Viscosity
Corrosion
Characteristics
Acute Oral
Toxlcl ty
Acute Dermal
To it! city
Acute Inhalation
Toxlclty
Primary Eye
Irritation
Primary Dermal
Irritation
Dermal Serialization
Does EPA Have Must Data be
Data to Submitted
Composition Satisfy this Bibliographic Under FIFRA
Characteristics Requirement Citation § 3(c)(2)(B)
Manufacturing-Use
Product No
Manufacturing- Use
Product Yes
Manufacturing- Use
Product Yea
Manufacturing- Use
Product Yea
Manuf ac tur ing-Use
Product Yes
Manufacturing-Use
Product Yes
Manufacturing- Use
Product Yes
Manufacturing-Use
Product Yes
Manufacturing- Use
Product Yes
Yes
00001SS3 and
00001SS6 and No
00001760 and
00001SS3 and
00001SS6 and No
00001760 and
000015SS and
00001S86 and No
00001792
00002227 No
00001591 Yes
00001590 No
00001593 Yes
GS0009-030 Yes
Months Allowed
Before
Submission
6
6
6
6
TERRAZOLE
-------
TABLE C
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS
GUIDELINES
SECTION
163.61-3
163.61-4
163.61-5
163.61-6
163.61-7
163.61-8(1)
163.61-8(2)
163.61-8(7)
163-61-8(8)
Name of Test
Product Identity and
Disclosure of Ingredients
Description of Manufacturing
Process
Discussion on Formation of
Unintentional Ingredients
Declaration and Certifi-
cation of Ingredient
Limits
Product Analytical Methods
and Data
Color of Formulation and
Technical
Odor of Formulation and
Technical
Physical State of Formu-
lation and Technical
Density or Specific Gravity
Composition
Characteristics
All Types
All Types
All Types
All Types with greater
than -It Impurities
All types with less than
.12 Impurities
All Types
All Types
All Types
All Types
Does EPA Have
Data to
Satisfy this Bibliographic
Requirement Citation
No
No
No
No
No
No
No
No
CS0009-036 and
Yes 00001760
Must Dsta be
Submitted
Under FIFRA
§ 3(c)(2)(B)
Yes
Yes
Yea
Yes
Yes
Yes
Yes
Yes
No
Months Allowed
Before
Submission
6
1
24
6
6
24
6
6
6
of Formulation and
Technical
All Types
No
Yes
TERRAZOLE
-------
Page 2 - Table C
GUIDELINES
SECTION
163.61-8(9)
163.61-8(10)
163.61-8(11)
163.61-8(12)
163.61-8(13)
163.61-8(14)
163.61-8(15)
163.61-8(16)
163.61-8(17)
163.61-8(18)
163.81-1
163.81-2
Name of Test
Boiling Point of Formula-
tion and Technical
Vapor Pressure of Formula-
tion and Technical
pll of Formulation and
Technical
Storage Stability
Flarnmablllty
Oxidising or Reducing
Action
Exploslveneas
Mlsclblllty
Viscosity
Corrosion Characteristics
Acute Oral Toxlclty
Acute Dermal Toxlclty
Composition
Characteristics
25Z EC
4 Ib/Callon EC
All Types
All Types
All Types
25Z EC
4 Ib/Callon EC
All Types
All Types
25Z EC
4 Ib/Callon EC
2SZ EC
4 Ib/Gallon EC
All Types
30Z WF/D and 3SZ WP
2SZ EC
4 Ib. /Gallon EC
5Z Granular
30Z WP/D and 3SZ WP
25Z EC
Does EPA Have
Data to
Satisfy this Bibliographic
Requirement Citation
No
No
Yes 00002232
Yes GS0009-035
No
No
No
No
No
No
No
No
No
No
Yes 00001 592
No
Yes 00001828
Yes GS00009-034
Yes 00001593
No
Must Data be
Submitted
Under FIFRA
S 3(c)(2)(B)
Yes
Yea
No
No
Yea
Yes
Yes
Yea
Yes
Yes
Yea
Yes
Yes
Yes
No
Yes
No
No
No
Yes
Months Allowed
Before
Submission
6
6
6
6
6
6
6
6
6
6
6
6
6
6
TERRAZOLE
-------
Page 3 - Table C
GUIDELINES
SECTION Name of Teat
Composition
Characteristics
Does EPA Have Must Data be
Data to Submitted Months Allowed
Satisfy this Bibliographic Under FIFRA Before
Requirement Citation § 3(c)(2)(B) Submission
163.81-2 Acute Dermal Toxiclty
163.81-3 Acute Inhalation Toxiclty
163.81-4 Primary Eye Irritation
4 Ib./Gallon EC
5% Granular
30Z WP/D and 35* UP
25Z EC
4 Ib./Gallon EC
5Z Granular
30Z WP/D and 35Z WP
25Z EC
Yes
Yea
No
No
Yes
Yea
No
Yes
00001831
GS0009-034
00001828
GS0009-03i
GS0009-031
No
No
Yes
Yea
Yes
Yes
Yes
163.81-5 Primary Dermal Irritation
163.81-6 Dermal Sensltlzatlon
30Z WP/D and 35Z WP
25Z EC
4 Ib./Gallon EC
5Z Granular
All Types
No
No
Yes
Yes
No
00001828
CS0009-034
Yes
Yes
No
No
Yes
TERRAZOLE
-------
3-(alpha-acetonylfurfuryl)-4-hydroxycoumarin)
(FumarinR)
-------
iARt.b n
<:KNKKIC DATA NKIJIJ i HKHKNTS FOR MANUKACIUHIHG-IISE AIIH END-USE PRODUCTS NOT EXEMPTED uv PIFRA SECTION 3(c)(2)(n)
CONTAINING FUMAttlN OR THE SODIUM SALT OF FUHAR1N
C II I DELINKS
CITATION
163.81-1
163.81-2
I63.UI-1
163.81-4
I63.AI-S
163.81-6
163.82-2
161. 83-3
163.84-1 ,2.1.4
NAME OP TEST
Acute Oral 1. 1> 5 Q ( 1 )
Acute Derma 1 ( ' )
1.050
Ar.utef l>
Inhalation LCjy
I'rlunry EyeO>
If r 1 Cot Ion
rrlraury Dermall1)
Irr Hat Ion
DC run 1 ( l )
Sen a 1 1 Iza I Ion
Suhrlironlc Denoall^J
Ter.i t a logy ( 1 )
NUL....!...,!.)
USE PATTERN MUST APPLICANT BI Bl. IOCRAPIIIC
ACKNOWLEDGE RELIANCE CITATION
UNDEA FIFHA $3(c)(l)(D)
All UHOB ho
All Useu No
All UUUB No
All Useu No
All Uaea No
All Uaea No
1 All UBCB No
All Uauu No
All Uaua No
MUST DATA B8
SUBMITTED UNDER
riFHA S3(c)(2)(B)
Yaa
Yea
Yea
Yea
Yaa
Yaa
Yea
Yea
Yes
MONTHS
ALLOWED
BEFORE
SUBMISSION
6
6
6
6
6
6
24
24
24
(I) Required on Tur.liu I ca 1 (active Ingredient).
FumarinR
-------
TADLK A - Co ii I I iniftl
UKNKHIC UAVA Hli END-USE PRODUCTS NOT KXEMFTED BY FIKKA SBCTIOH 3(c)(2)(l>)
CUNTAIN1NC KUHAR1N OH THE SODIUM SALT Of FUMARIN
GUIDELINES
CITATION
163.71-1
163.71-2
HAMK UK TKST USK fATTI-UN
Avid 11 Singlet2) All iieua
Uoac LDjo except ilnnpa
Dumps
Siibucute Dletury(Z) All uaca
LC5II Mallard nil U except dumpa
ItUSf APFI.ICANT BIBLIOGRAPIIIC
ACKNOWLEDGE HKI.IANCE CITATION
UNDER FIFHA S3(c)(l)(U)
II 0
No
No
HUST DATA BE
SUBMITTED UNDEH
PIFHA (3(c)(2)
-------
IAUI.E A - i.nul I iwic«l
(iKNI'.KIC DATA RBQUI RI-.MI-NTS FOR MANUFACTUKIHU-IISE AND END-USE I'KOOUCTS NOT EXEMPTED UY FIFRA SECTION 3(c)(2)(D)
CUNTA1NINC PUMAKIN OK THE SODIUM SALT OP FUMARIN
CIIIIIbl.lNES
CITATION
NAIIi: OF TEST
USB PATTERN
MUST APPLICANT
ACKNOWLEOCIi RELIANCE
UNDBIl FIFKA $3(c)(l)(U)
BIDLIOCHAFHIC
CITATION
MUST DATA BE MONTHS
SUBMITTED UNUEK ALLOUKU
FIFRA $3(c)(2)(B) BEFORE
SUBMISSION
163.71-3
163.71-3
163.70-l(c)
Trt r(j i:t Rodent
S|>cc lea
All uses
encept Jump a
Una pa
No
No
Prloi4ry Dietary^2)
I.C5O on Carnlvorun
All it a e a
except dumps
Du op a
No
No
Siiciindary Toxlclty(2> All UBUS
Fucdlng Study on except dumps
Carnivores _ ___
Dumps
No
No
I63.70-l(c) Uci-undury To»lclty<2) All uaea
Fuudlng Study on except dunpa
Hn|ilura _ _
Dumps
No
No
No
Yea
12
No
Yea
12
No
Yea
12
NO
Yea
12
(2) Required un Tecliuloal Fiiunrln and Technical Sodium Salt of Fuiaarln (pureat for™ of Technical).
FuraarinR
-------
TABLE H
I'KODUCT-SPtCIFIC DATA REIJUIREHENTS F()K MANUFACTURING-USE PRODUCTS
fill IDE LINES
CITATION
161.61-3
163.61-4
163.61-5
163.61-6
163.61-7
163.61-8(1 )
NAME OF TEST
I'rudnct Identity
Disclosure of
I n g r e d 1 e n t a
Description of
Ha n u f ac tnr 1 ng
Process
Discussion on
Formation of
Unintentional
I ngred ieiila
liec 1 a rat Inn and
Cert If 1 cat Ion of
Ingredient Limits
Product Analytical
Muthoda and Data
Color(2)
COMPOSITION CHARACTERISTICS
Technical Fuoarln Sodium Salt
Technical Fiimarln
F uma rln (501. IOX. O.SX)
Technical Ftimarln Sodium Salt
Technical Fiimarln
Fiimarln (SOX. IOX. O.SX)
TECHNICAL Fumarln Sodium Salt
Technical Funarln
Funarln (SOX. IOX, 0.5X)
Technical Fumarln Sodium Salt
Technical Funarln
Fuoarln (SOX. IOX, O.SX)
Technical Fiimurln Sodium Salt
Technical Fumarln
Fumarln (SOX, IOX, 0.5*)
Technical Fuiaarln Sodium Salt
Technical Fumarln
Fnmarlu (SOX. IOX, O.SX)
DOES BPA Ml
HAVE DATA TO SI
SATISFY THIS BIBLIOGRAPHIC $
REQUIREMENT CITATION Fl
No
No
No
No
No
No
No
No
No
No
No
No
Yea 00001200
Yea 00001200
No
No
Yea 00001199
No
JST DATA BE
JBHITTED UN
3(c)(2)(B)
IFRA
Yes
Yea
Yea
Yea
Yea
Yea
Yea
Yea
Yea
Yea
Yea
Yea
No
No
Yea
Yea
No
Yea
; MONTHS
DER ALLOWED
BEFORE
SUBMISSION
6
6
6
6
6
6
6
6
6
6(24j)
6(24')
6(241)
_ •
-
6
6
-
6
Any Impurities at O.IX or leaa - Information need not be submitted until 24 laonlha.
Required on both the formulated and the technical (puruat form of active Ingredient) products.
-------
TABLE H - CONTINUED
IMIOIH/CT-SrECIKIC DATA RE«J«J IKEIIENTS FOR HANUFACTUH ING-USE PRODUCTS
Gil 1 1)8 I.I UBS
CITATION
163.61-8(2)
163.61 -8(3)
163.61-11(4)
163.61-8(6)
161.61-8(7)
163.61-8(8)
NAME OF TEST
Odor<2 )
He Id » B Point
Solubl 1 I ty
Octanol/Uater
Part 1 C Ion
Coef f 1 clout
I'byalcnl State
Deusl ty or
Spue If Ic
Gruvlly<2)
DOES EPA
HAVE DATA TO
SATISFY THIS BIBLIOGRAPHIC
COMPOSITION CIIAKACTERISTICS REQUIREMENT CITATION
Technical Fumarln
Technical Fumarln
Fiimarln (501. IDS
Technical Fumarln
Technical Pumarln
Fuiourln (SOX. 10Z
Technical Fumarlii
Technical Fuoarln
Fumarln (501. 10X
Technical Funarlii
Technical Fumarln
Fuaarln (JOS. 10X
Technical Kumar In
Technical Fumarln
Fuoarlii (501. 10X
Technical Funarln
Technical Fumarln
Fuaarln (501, IOZ
Sodium Salt
,0.51)
Sodium Salt
, O.SZ)
Sodium Salt
. O.SZ)
Sodium Salt
. 0.5Z)
Sodium Salt
. 0.5Z)
Sodium Salt
, O.SZ)
No
Yea 00001199
No
No
Yea 00001199
No
No
No
No
No
No
No
No
Yea 00001199
No
No
No
No
MUST DATA BE MONTHS
SUBMITTED UNDER ALLOWED
S 3(c)(2)(B) BEFORE
FIFRA aUBMISSIC
Yes
No
No
Yen
No
No
Yea
Yea
No
Yea
Yea
No
Yea
No
Yea
Yea
Yea
Yce
6
-
~
6
-
~
6
6
"
6
6
™
6
-
6 "
6
6
*
(2) Kuqulriid an botli the formulated and the technical (purest fora of active Ingredient) products.
FumarlnR
-------
TAIII.K U - CONTINUED
t'ROIIUCT-Sl'HClFIC HAfA ht(jll IKEHEHI'S FUR MANUFACTUR I HC-USE PRODUCTS
GUIDELINES
C_l_TAT 10N HAHIi Of TEST
163.61-8(9) Dolling Point
COMPOSITION CHARACTERISTICS
Technical Fumarln Sodium Salt
Technical Fuaarln
DOCS EPA
HAVE UATA TO
SATISFY THIS
REUUIRENRN1
BIBLIOGRAPHIC
CITATION
MOST DATA BE
SUBHIVTBU UNDER
S 3(c)(2)(B)
FIFBA
MONTHS
ALI.OUEU
BEFORE
SUBHISSIOH
Fuaarln (5OZ. 1OZ. O.5I)
163.61-8(10) Vapuc Pressure
Technical Fuaarln SoJIim Salt
Fu_« a r ^n
~"
_
", 0/5X)
Ho
Ho
No
Ho
No
Ho
¥eo
Yea
YOB
Yes
Yea
Yea
6
6
6
6
6
6
163.61-6(11) pll
..Fumartii SoJIua Salt
Technical Fumarln _
Fuuarln~(50X7 IOZ,"0.5X)
Ho
Yes
No
No
Yea
Yea"
163.61-8(12) Storngu Stability Technical Fumarin Sodlua Sott
Technical Fumarln
Fuaarln (501, IOX. 0.51)
No
No
No
Yea
Yea
Yea
6
6
6
161.61-8(13) Flamujibll ley
Technical Fuaarln Sodium Salt
Technical Fuoarln
Funarln (SOX. IOX. 0.51)
Ho
No
No
Yea
Yea
Yea
6
6
6
16J .61-8(14) OMldlzlng or
Meiliicliig Action
_ In Sodium Salt
Technical FuaaMn _
Fuaarln { SO'X ."fol", ~o75X )
No
JNo
Ho"
_
No
Yea
Fumarin^
-------
TABLE II - CUNriNIIKIl
I'ROUUCT-SI'ECIFIC DATA REQUIREMENTS FOR MANUFACTUHINC-USE PRODUCTS
Gill UK LINKS
CITATION
1 61.6I-B(1S)
161.61-8(16)
163.71-1
161.71-2
161.72-1
161.72-2
NAME OF TEST
Explosive n eea
Cor roa toil
Character lat leu
Avluu Slngle-O)
Itoae
Oral LDjQ
AvI u n Die ta ryO
LC50 Hal lard 8
Bub WhUu Quail
Flail Acute LCj0(3)
Rainbow Trout
a it d blueglll
Acute Toxlclty(3)
to Al|lld t 1 C
I uvur t ubrate
DUES EPA
HAVE DATA TO
SATISFY THIS
COMPOSITION CHARACTERISTICS REQUIREMENT
Tecliutcal Fuiaarln Sodium Salt
Technical Fuuarln
Fuaarln (SOZ. 10Z. O.SZ)
Technical Fumarln Sodluo Salt
Technical Fumarln
Fuaarln (501. 10Z. O.SZ)
Technical Fuiaarln or Ita Sodium
Salt
Kumar tn (50Z. 10Z. 0.5X)
Ta clinical Fuuarln or Ita Sodium
Salt
Fumarln (SOZ. 10Z. O.SZ)
Technical Fumarln or Ita Sodium
Salt
Fumarln (SOZ. IOZ, O.SX)
Technical Fumarln or Ita Sodium
Salt
Fumarln (SOZ. IOZ. O.SZ)
No
Ho
No
No
No
No
No
No
No
No
No
No
No
No
HUST DATA BE MONTHS
SUBMITTED UNDER ALLOWED
BIBLIOGRAPHIC $ 3(c)(2)(B) BEFORE
CITATION FIFRA SUBMISSION
No
No
Yea
Yea
Yea
Yea
No
No
No
No
No
No
No
No
_
-
6
6
6
6
6
6
6
6
6
6
6
6
(1) Tlicflu riHh diid wlldllfu atinllea are required on Technical (|iuraat fora active Ingredient) for use of product. Involving dump
a I l u u .
Fumarin
R
-------
TABLE H - OONMNUKU
DATA HEO.IJfHEMENTS FUH HANUPACTURINO-USE PRODUCTS
GUI OKI. INKS
CITATION
161.71-3
163.72-3
1 63.70-l(c)
l»1.7n-l(c)
1 63.61-1
163.81-2
NAME OF TEST
Ulutury I.C,0(3)
Target Koilcnt
!i l> c c lea
PrloMry DletaryO)
I.Csn on
Carat vurea
Secondary toxl-(^)
city Feeding Study
on Carnivores
Secondary toxl-O)
city Feeding study
on Raptors
Acute Oral LU50(4)
Tnxlcl Ly
Ac ii I c Dermal LCjo(4
Tuxl c 1 Ly
COHI'OSITION CHARACTERISTICS
Technical Puraarin or
Salt
Fnunrln (SOI, 10Z, 0
Technical Fuoarln or
Salt
Funrtn (SOX. IOZ. 0.
Technical Fuaartn or
Salt
Fuaarln (SOX, 10X. 0
Technical Fuaarln or
Sodium Salt
Fuoarln (SOX, 101. 0
Technical Kumar In
Fuaarin (SOX. IOZ, 0
) Technical Funarln
Fuioarln (SOX, 10X, 0
Ita Sodium
.51)
Its Sodium
51)
Ita Sotllun
•SX)
Ita
.51)
• 5X)
•SI)
noes EPA MUST DATA BE MONTHS
I1AVK UATA TO SUBMITTED UNDER ALLOUBU
SATISFY TIMS BIBLIOGRAPHIC & 3(c)(2)(B) BEFORE
HEI1UIREHEHT CITATION FIFRA SUBMISSION
No
No
No
No
No
Ho
Ho
No
No
No
No
No
No 12
No 12
No 12
No 12
Yea 12
Yea 12
Yea 12
Yea 12
Yea 6
Yea 6
Yea 6
Yea 6
CD Theae fluli situs.
(4) Thu Auuucy can uau data on Teclintcal Fiinarln to satisfy tbla roq.i I r eoent for tlie SOX and 1OX formulations. The registrant must
either cite or uuhmll these datn.
. R
-------
if a
'tut ' ""•••)
/HO-...,. Sl'bbiriC DAI A HEillllHEHUNl'S FOH MAHIIFACTU« INC-USE PRODUCTS
UU1UK1. IMES
CITATION
163.81-3
1 63.81-4
163. 81-)
1 ft 1 HI A
163.83-2
I63.B3-3
16.1.84-1,
NAME OP TEST
Acute In ha 1 at lout4)
'•C50 Tax lei ty
Primary Eye<*>
Irrl tnt Ion
I'rliaary Uurmal'*)
Ire 1 tat Ion
Send 1 t 1 cation
Snb-Ch runic
Derma I
Te ra tology
Hut » cen Ic 1 Ly
COMPOSITION CHARACTERISTICS
Technical Fuoarln
Fumnrln (SOX. iOX. 0.5Z)
Technical Fiinarln
Funarln (SOX, )OX, O.SX)
Technical Fuoarln
funactn (SOX. IOX. O.SX)
Technical Funarln
Fiiuarln (SOX. tOX, O.SZ)
Technical Fuunrlu
Technical Ftioarlu
Teclmlcal Kunarln
U
-------
PRODUCT-SPECIFIC I)ft'I'A REQUIREMENTS FOR EHD-USE PHODItCTS
TABLE C
GUIDELINES
CITATION
163.61-3
- _j
-6
-oin
-BJ2|
imr-B(D
-BO)
-eiai
-BC9)
-8(10)
163.61-0(11)
-umr •
• -BTHl
-B1H)
ttAHE OS1 TEST
Precinct identify and
disclosure of
Ingredients
Description cf
manuEactur Ing
pioceaa
Ctrl float Ion limits
of Act Ive Ingredient
Color
Odor
Solubility
Physical state
Density or Specific
Gravity
Dolling Point
Vapor Pressure
p»
Storage Stability
PI a mutability
Oxidizing reducing
action
COMPOSITION CHARACTERISTICS
Fumar In
Fl:MAfllM SODIUM SALT
FIIMARIH
FUMAHIH SODIUM SALT
FIIMAPIN
FUMAR IN SODIUM SALT
FUMAItiN hF.ADY
FIJMAIUN BOH 1 UK SALT
FUMAItlH
FUMAR IN SOU HIM SALT
Funicr In
Fi'MAHlN CblllUM SALT
.FUMAIIIN
FUMAUKI SODfUM SALT
FUMAIMN
F( IMA lltri
[•iiMAiiiu souiiiM sM.f
fUMAIilH
FilMAKIH SODIUM SALT
Fumar In
FUMAIilH SODIUM SALT LIQUID BAITS
FUMAItlH
TIIMA1UN SODIUM" SA1T
FUMAItlH
FUMAUIN SODIUM SALT'
FUMARIII
FUMAnill SODltIN SALT
DOES EPA HAVE
DATA TO SATISFY
THIS REQUEST?
No
Ho
No
"No
Ha
do
No
No
Ha
Ha
No
No
- • Ho '
HO
No
No
^~No
No
Ha
No
No
Ho
ho
Ha
No
Ho
Ho
DIBLIO- Must Data DE
GRAPHICS SUBMITTED
CITATION UNDER FIFRA
S 3(c)|2)(D)
Yes
Yes
Yes
res
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
res
•»es
Yes
les
No
Yes
No
Yes
Yes
Ves
Yes
Yes
Ves
Yes
Yes
MONTHS
ALLOWED
BEFORE
SUBMISSION
6
6
6
«
6 or 24 11)
E or 24 (1)
. g. r,
6
6
6
6
6
6
6
6
fi
6
6
6
6
6
6
6
6
(I) Any iiii|>iir 11. ios at O.I* or losu. Information need not he submitted until 24 months.
Fumarin
R
-------
DATA IIEUIIIUKHEMTS run END-USE PRODUCTS
""fiiitifEi.iiiRB"" HAMB bv "TIIST "COMPOSITIOII CHARACTERISTICS DOES EPA HAVE mono- Must Data BE MONTHS
CITATION DATA TO SATISFY GRAPHICS SUBMITTED ALLOWED
THIS REQUEST? CITATION UNDER FIFRA BEFORE
S 3(0 (2MB) SUDMISSION
-6(15) ExploalvenOES FOMAR1H
FUMAHlii SODIUM SM.T
163.61-8(16) Corcoalnu
character latica Funarln
FUMAiUN SODIUM SALT
lf>3.9ft-10 i:f(iccicy ruilARIM
FUMAItIN SODIUM SALT
I63.BI-I Acute Oral 11)50 FUHARIN (0,5%, 0.025%)
Toxlclty (2) rUMARlN SODIUM SALT
163.81-2 Acute Dermal LD50 FUHARIN (0.5%, 0.025*)
Tojtlclly FUHARIN SODIUM SALT
163.81-3 Anile Inhalation FUMAIUN (0.5t. 0.025%)
LC50 Toxlclty (2) FUMARIN SODIUM SALT
63.81-4 Primary Eye FUMARIN (0.52. 0.025t)
Irritation FUHAHIN SODIUM SALT
63.61-5 Primary Dermal FUMARIN (0.5X, 0.025%)
Irritation [2) ;UMARIN SODIUM SALT
63.01-6 Derni.il FUMAiUN (0.5%. 0.0251)
Sensltizdtion (2) FUMARIN SODIUM SALT
No Yes
UnCcr to Appendix VI for
Ihcae requirements
Refer to Appendix VI for
lliese requirements
No Yes
Mo Yes
No Yes <
No Yes :
No Yes
No Yes
No Yes '
to Yes i
No Yes
Fo Yes
No Yes
No Yes
6
6
6
6
6
6
6
6
'.) 6
1 6
6
6
1 6
! 6
6
6
6
6
(2) The Agency can use data on 0.51 Fumarln to satisfy this requirement. The registrant must cite these data or submit his own data.
(3) This study will he required unless a dissociation study under ull conditions comparable to skin epidermis shows that the Salt readily
dissociates Into Fumarin and Sodium Ion. If not required, Footnote 2 would apply.
(4) For 0.5X Fumarln products, one test will be required. For 0.025% granular Fumnrln products, at least one, repre-
sentative formulation shall be tested. Registrants of these products should refer to Attachment D (Registrants with Pesticide Products
Containing tlic Active Ingredient) to determine If their products are considered granular formulations. If serious problems arise,
all formulations must be tested to assure proper labeling and safety to consumers and formulators. (These tests are not required for
products whose fill Is less than 3 or greater than 12.)
-------
IV. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA UNDER FIFRA
S 3(c) (2)(B)
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 to fill "gaps" identified by EPA concerning your
product. Under the authority of FIFRA section 3{c)(2)(B) EPA has
determined that you must submit these data to EPA in order to maintain
the registration of your product(s). All this data must be submitted not
later than 6 months after you receive this Guidance Package.
The tables entitled "Product-Specific Data Requirements for
Manufacturing-Use Products" and "Product-Specific Data Requirements for
End-Use Products," which appear as Tables B and C of this Guidance
Package, permit you to determine which product-specific data you must
submit. This can be done by examining the entries in the column of those
tables entitled "Must Data Be Submitted Under 5 3{c)(2)(B)."
In some cases the Tables may note that EPA already possesses some or all
of the product-specific data needed to evaluate your product; if that is
the case, we encourage you to elect to cite that data in lieu of
generating and submitting new data. (You must comply with FIFRA
Section 3 (c)(1)(D) if you elect to cite existing data; see Section II of
this Guidance Package.)
The Tables also indicate that in some cases, a product-specific data
requirement for a group of similar products can be satisfied by a single
test.
12
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Your application for registration must include a completed copy of the
form entitled "Product-Specific Data Report" (Appendix II-2), stating the
methods you are using to comply with the product-specific data requirements.
V. Submission of Revised Labeling, Classification, and Packaging Information
The Agency has determined to require applicants for registration to amend their
product's labeling order to insure that each label (1) contains accurate,
complete, and sufficient instructions and precautions, reflecting the results
of data concerning the product and its ingredients, and (2) incorporates labeling
format and terminology which are sufficiently standardized to avoid user confusion.
As part of your application for reregistration, you must submit draft labeling
revised to be consistent with: your product-specific data; the precautionary
statements and use directions described in Chapter II* of the Registration
Standard; and the regulations concerning classification [40 CFR § 162.11(c)],
packaging [40 CFR § 162.16], and labeling [40 CFR § 162.10], as indicated by
the following paragraphs of this section of the Guidance Package. The labeling
must be submitted within 6 months of your receipt of this Guidance Package.
If you fail to submit revised labeling and packaging information complying
with this section, EPA will issue a notice of intent to cancel your registration
under FIFRA § 6(b)(1).
* For Fumarin, the use directions are found in Chapter IV of the Registration
Standard.
13
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A. Label Contents
In 40 CFR Section 162.10 (Appendix V-l) it is required that specific
labeling statements must appear at certain locations on the label.
This is referred to as format labeling. Leeway for product
individuality is provided in format labels, but only with the
recognition that the label is a legal document to instruct the user
on use and safety. Items listed below are keyed to Tables D, E, and
F (Appendix V-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. In certain instances, the name of a product may be
considered a claim for the product, and will not be accepted if it
represents claims which may be false or misleading. See Appendix
V-l. [40 CFR §162.10(b)]
Item 2. COMPANY NAME AND ADDRESS - The company name and address of
the producer, and the registrant or person for whom material is
produced is required on the label. It is preferred that the name and
address be located at the bottom of the front panel, or at the end of
the label text. If the registrant is not the producer, the name on
the label must be qualified by "packaged for xxx," "Distributed by
14
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xxx," or similar statements as appropriate. See Appendix V-l. [40
CFR §162. 10(c).]
Item 3. NET CONTENTS - A net content statement is required on all
labels. It is preferred that it be located at the bottom of the
front panel immediately above the company name and address, or at the
end of the label text. The net content must be stated in terms of
weight, expressed as avoirdupois pounds and ounces, and stated in
terms of the largest suitable unit, i.e., "1 pound 10 ounces" rather
than "26 ounces." In addition to the required units specified, net
content may be expressed in metric units. See Appendix V-l. [40 CFR
Sl62.10(d)]
Item 4. PRODUCT REGISTRATION NUMBER - The registration number
assigned to the pesticide product at the time of registration must
appear on the label, preceded by the phrase "EPA Registration No.,"
or the phrase "EPA Reg. No." The registration number must be set in
type of a size and style similar to other print on the 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 V-l.
[40 CFR §162.10(e)]
15
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Item 5. PRODUCING ESTABLISHMENT 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,
but not on the cap or lid of the 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. See Appendix V-l. [40 CFR
Sl62.10(f)]
Item 6A. INGREDIENT STATEMENT - An ingredient statement which
contains the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients are
required on the front panel. It is preferred that it be located
immediately below the product name. 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. See Appendix V-l. [40 CFR
§162.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For agricultural liquid
formulations, the pounds per gallons of active ingredient must be
indicated on the label.
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Item 7. FRONT PANEL PRECAUTIONARY STATEMENTS - All labels are required
to have precautionary statements grouped together on the front panel,
preferably within a block outline. The table below shows the minimum
type size requirements on various sized labels, as set forth in the
Regulations. It should be noted that proposed labeling guidelines
require a minimum 8 point (3mm) type size for all print on a label. When
the Guidelines are finalized, the below list may be modified accordingly.
Size of label on Signal Word as Required "Keep out of Reach
front panel in Minimum Type Size of Children" as
square inches All Capitals Required
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Item 7A. CHILD HAZARD WARNING STATEMENT - All labels are required to
have the statement "Keep Out of Reach of Children" located on the front
panel above the signal word. See Appendix V-l. [40 CFR §162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (Caution, Warning, or Danger) is
required on the front panel, immediately below the child hazard warning
statement. See Appendix V-l. [40 CFR §162.10(h)(1)(i)]
6 point
10 point
12 point
14 point
18 point
6 point
8 point
8 point
10 point
12 point
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Item 7C. SKULL & CROSS BONES AND WORD "POISON" - Refer to the
registration standard to determine if the skull and cross bones and
"poison" designation is required on your product label.
Item 7D. STATEMENT OF PRACTICAL TREATMENT - Refer to the second chapter
of the Registration Standard.
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 V-l. [40 CFR $162.10(h)(1)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The precautionary
statements as listed below must appear togther on the label under the
heading "PRECAUTIONARY STATEMENT." It is preferred that they appear at
the top or side of the back panel, preceding the directions for use, and
that they be surrounded by a block outline. Each of the three hazard
warning statements must be headed by the appropriate hazard title. See
Appendix V-l. [40 CFR $162.10(h)(2)1
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - The following
precautionary statement may be required on certain product labels
containing this active ingredient. Refer to the registration standard to
IS
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determine if your product should contain the statement: "HAZARD TO
HUMANS & DOMESTIC ANIMALS"
Item SB. ENVIRONMENTAL HAZARD - Environmental hazard statements may be
required on certain product labels containing this active ingredient.
Refer to the registration standard to determine whether or not your
product label should bear any such statement and the precise wording of
the statement.
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 V-3. The requirement is based on the
results of the flash point determinations and flame extension tests
required to be submitted for all products. These statements are to
be located in the side/back panel precautionary statements section,
preceded by the heading "Physical/Chemical Hazards." Note that no
signal word is used in conjunction with the flanunability statements.
2. Criteria for declaration of non-flammability. The following criteria
will be used to determine if a product is non-flammable:
19
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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 flash point greater
than 350°F (177°C) as determined by the method specified in
40 CFR §163.61-8(c)(13)(ii) of Subpart D.
c. A "non-flammable aerosol" is one which meets the following
criteria:
i. The flame extension is zero inches, using the method
specified in 40 CFR §163.61-8(c)(13)(ii).
ii. There is no flash back; and
iii. The flash point of the non-volatile liquid component is
greater than 350°P (177°C), determined by the method
specified in 40 CFR §163.61-8(c)(13)(i).
3. Declaration of non-flammability. Products which meet the criteria
for non-flammability specified above may bear the item
"non-flammable" or "nonflammable (gas, liquid, etc.)" on the label.
20
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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) that may detract from
precaution.
4. Other physical/chemical hazard statements, when chemistry data
submitted in accordance with 40 CFR §163.61-10(c) demonstrate hazard
of a physical or chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such statements may address
hazards of explosivity, oxidizing or reducing capability, or mixing
with other substances to produce toxic fumes.
Item 9. PRODUCT CLASSIFICATION: CLASSIFICATION LABELING REQUIREMENTS
AND COMPLIANCE SCHEDULE - Section 3(d) of FIFRA requires that all
pesticide formulations/uses be classified for either general or
restricted use, and that those uses classified as restricted be limited
to use by certified applicators or persons under their direct supervision
(or subject to such other restrictions as may be imposed by regulation).
In Chapter 2 of the registration standard, the Agency has: (1) indicated
certain formulations/uses to be restricted based either on a previous
classification determination made through the optional procedures of 40
CFR §162.30 or based on data already available to the Agency, or
(2) indicated certain formulations/uses to be unrestricted based on data
21
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already available to the Agency, or (3) reserved any classification
decision until appropriate short-term data are submitted. Uses have not
been classified for general use at this time because such a decision
requires an evaluation of chronic data most of which has yet to be
generated.
The product-specific data required by the Standard should be used by each
registrant to make a classification determination following the criteria
of 40 CFR Sl62.11(c) (Appendix V-4). The draft label(s) submitted to the
Agency as part of your application should reflect this determination and
must be consistent with the terms of 40 CFR S162.10 and this guidance
package with respect to label language and format for restricted use
products. (No label changes with respect to classification are required
for products with unrestricted uses.) The rationale supporting a
classification proposal by the registrant that differs from a
classification determination found in the Standard should be submitted
with your application.
During the Agency's review of your application, your proposed
classification determination will be evaluated in accordance with the
provisions of 162.11(c). You will be notified of the Agency's
classification evaluation.
22
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A. Classification Labeling Requirements
1. Unrestricted Uses - No label changes with respect to a
classification statement are necessary for those
formulations/uses that are unrestricted.
2. Restricted Uses - Pesticide products bearing directions for use
for formulations/uses classified restricted shall bear
statements of restricted use classification on the front panel
as described below:
a. Front panel statement of restricted use classification.
i. At the top of the front panel of the label, set in
type of the same minimum sizes as required for human
hazard signal words (see table in 40 CFR
§162.10(h)(1)(iv)), and appearing with sufficient
prominence relative to other text and graphic material
on the front panel to make it unlikely to be
overlooked under customary conditions of purchase and
use, the statement, "Restricted Use Pesticide" shall
appear.
23
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ii. Directly below this statement on the front panel, a
summary statement of the terms of restriction 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.
3. Some But Not All Uses Restricted - If you determine that some
*
uses should be classified RESTRICTED and some uses should be
unrestricted, several courses of action detailed below are
available:
i. You may delete all RESTRICTED uses and submit a draft label
of the registration of your product to reflect only those
uses that are unrestricted.
ii. Unrestricted uses may appear on a RESTRICTED label, but not
vice versa. Therefore, you have the option of using a
24
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RESTRICTED USE label bearing all of your directions for
use. If you choose this option, you may not distinguish
those uses that are not unrestricted from those that are
RESTRICTED.
iii. You may register two separate products with identical
formulations, one containing only unrestricted uses and the
other RESTRICTED uses. To do so, submit two applications
for reregistration, each containing all forms and necessary
labels. Both applications should be submitted
simultaneously. Note that the product names will be
assigned separate registration numbers.
B. Compliance Schedules
1. Unclassified uses - None.
2. Restricted uses - The compliance schedule for restricted use
products begins only after the approved label is returned to
you as follows:
a. No product with a use classified for restricted use under
this first phase of reregistration may be released for
shipment by the registrant or producer after the 120th day
25
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after the date of acceptance of the label submitted in
conjunction with your application, unless such product
bears the new accepted label or has supplemental labeling
affixed or is accompanied by supplemental labeling. For
the purposes of the first phase of reregistration,
supplemental labeling means:
(i) an adhesive sticker containing the restricted use
statement specified in 40 CFR 162.10(j)(2) and also
found in this section;
ii. a separate form containing the product name as it
appears on the restricted use statement specified in
40 CFR §162.10(j)(2) and also found in this section,
and
iii. the approved new label.
b. No product with a use classified for restricted use under
this first phase of reregistration may be distributed or
sold by retailers or other persons after the 270th day
after the acceptance of the label submitted in conjunction
with your application, unless such product bears the new
accepted label or has supplemental labeling affixed or is
accompanied by supplemental labeling.
26
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c. No product with a use classified for restricted use under
this first phase of reregistration may be released for
shipment by the registrant or producer after the 270th day
after the acceptance of the label submitted in conjunction
with your application, unless such product bears the new
accepted label.
d. In cases where a registrant chooses to delete product uses
classified as restricted under the first phase of
reregistration, no such product may be released for
shipment by the registrant or producer after the 180th day
after acceptance of the label submitted in conjunction with
your application, unless such product bears the new
accepted label.
e. No product with a use classified as restricted under this
first phase of reregistration may be advertised without
including the restricted use classification after the 120th
day after the acceptance of the label submitted in
conjunction with your application.
Brochures, technical pamphlets and similar material which
are in final printed form on the date of acceptance of the
27
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new label may be distributed only for 270 days from the
date of acceptance.
Item 9C. MISUSE STATEMENT - The following statement is required on
your label: It is a violation of Federal law to use this product in
a manner inconsistent with its labeling. Appendix V-l. [40 CFR
§162.10(1) (2) (ii)]
Item 10A. RE-ENTRY STATEMENT - If there is a reentry statement for
your product, that statement will be set forth in the second chapter
of the standard.
Item IOC. STORAGE & DISPOSAL BLOCK - All labels are required to bear
storage and disposal statements. These statements are developed for
specific containers, sizes, and chemical content. Make certain that
the statement you use pertains specifically to your product. 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 V-5 of the latest specific storage and disposal product
labels.
Item 10D. DIRECTION FOR USE - Directions for use must be stated in
terms which can be easily read and understood by the average person
28
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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 V-5. [40 CFR §162.10]
B. Collateral Information
Bulletins, leaflets, circulars, brochures, data sheets, flyers and
other graphic printed matter which is referred to on the label or
which is to accompany the product are termed collateral labeling.
Such labeling may not bear claims or representations that differ in
substance from those accepted in connection with registration of the
product. It should be made part of the response to this notice and
submitted for review.
C. Special (Child Resistant) Labeling Requirements
As required in 40 CFR 162.16 (Appendix V-6), any pesticide that is
released for shipment by the registrant after March 9, 1981 must be
in special packaging if:
(1) its labeling permits residential use;
(2) it has not been classified for restricted use and
29
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(3) it meets the toxicity criteria of 40 CFR 162.16(c)(2).
Additional information on child resistant packaging is being developed
and will be mailed to you shortly.
VI. Instruction for Submission
All applications prepared in response to this Notice should be addressed
as follows:
Product Manager
Phone No. (202)
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
For each affected product for which continued registration is desired,
you must:
A. Within 90 days from receipt of this package you must submit the
"FIFRA" Section (3)(c)(2)(B) Summary Sheet (Appendix II1-2) with
appropriate attachments.
30
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B. Within 6 months from receipt of this package you must submit:
1. "Application for Amended Pesticide Registration" (EPA Form
8570-11) .
2. "Confidential Statement of Formula" (EPA Form 8570-4).
3. "Data Compensation Statement: Reregistration" (Appendix II-l).
4. Product Specific Data Report (Appendix I1-2).
5. Two copies of any required product-specific data.
6. Two copies of draft labeling, including the label and associated
brochures. If the current accepted labeling conforms to the
requirements of the guidance package and the results of the
short term data, the registrant can submit such labeling.
Otherwise, the labeling should be in draft form. The draft
labeling should be either type-written text on 8 1/2 x 11 inch
paper or a mock-up of the labeling suitable for storage in 8 1/2
x 11 inch files. The draft label must indicate the intended
31
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colors of the final label, clear indication of the front and
side panels, and the intended type sizes of the text.
7. A progress report on the development of generic mid-term and
long-term data.
C. Within 24 months from the receipt of this package you must submit:
1. All required generic mid-term data (Table A).
2. A progress report on the development of generic long-term data
(Table A).
D. Within 42 months from the receipt of this package you must submit the
generic long-term data as committed (Table A).
Note: If for any reason any required test is delayed or aborted so that
meeting the agreed submission time will be delayed, notify the
Product Manager listed above.
32
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VII. STATEMENT ON AGENCY POSITION REGARDING COURT SUITS
INVOLVING" FIFRA SECTION 3 (c) (1) (D)
Several companies have sued EPA in an attempt to block implementation
of FIFRA Section 3(c)(1) (D), which allows EPA to consider one firm's
data in support of reregistration of another firm's product. EPA
considers all available generic data in preparing a registration
standard. If the companies are successful in the litigation, they
could then use the reregistration process as a means of forcing
competitors off the market. EPA does not intend to allow the reregis-
tration requirement to be distorted in this fashion. If your appli-
cation for reregistration would be affected by this litigation, you
will receive further instructions from EPA before the time your
application must be submitted to EPA.
33
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Appendix II-l
DATA COMPENSATION STATEMENT: REREGISTRATION
EPA Reg. No.:
Product Name:
Applicant's Name & Address:
Date of application for reregistration:
Registration Standard for products containing:.
Date Reregistration Standard Issued:
Date Reregistration Guidance Package Issued:,
In connection with applicant's application for reregistration under the
Registration Standard and Guidance Package identified above:
(A) Applicant offers to pay compensation to other persons to the extent
required by sections 3(c)(1)(D) and 3(c)(2)(D) of the Federal Insecticide,
Fungicide, and Rodenticide Act, as amended.
(B) Applicant understands and acknowledges that if EPA appoves the
application, the approval will be based solely on EPA's consideration of:
(1) All the generic data which, according to the Registration
Standard and Guidance Package identified above, were found relevant to EPA's
evaluation of the registrability of applicant's product (taking into account
the product's composition and formulation category, and the uses its label
will permit); and
(2) The product-specific data listed on the form entitled
"Product-Specific Data Report" which is part of this application.
(3) Applicant states that offers to pay compensation have been
furnished to the persons and in the form specified by the Guidance Package
identified above.
Dated:
Name of registrant's
authorized representative:
(signature)
(typed)
-------
PRODUCT SPECIFIC DATA BBFQRX
Appendix II-J
SPA Registration BO.
Reg.Std for
Data Reg. Std. lasuedi
Guidance Package Datat
Registration
Guideline
No.
163.61-3
-4
-S
-6
7
163.61-8(1)
-8(2)
-9(3)
-8(4)
-8(5)
-8(6)
-8(7)
. -8(81
-8(9)
-8UO>
-8(11)
-8(12)
-8(13)
-8(14)
-8(13)
-8(16)
-8(171
-8(18»
-8(19)
1*3.71-5(1)1
-5(2)
163.72-1
-2
-3
-«la) (1)
-«(a)(2)
1*3.31-1
-2
-3
-4
-5
-6
Name of
Test
Produce identitity and disclosure ingredients
04 script ion of Danufaeturing process
Oiaeucaion on formation of uaintancunal
ingredient
Daclarauon and certification of ingredient
limiM
Product analytical nettioda and data
Color
Odor
Meltue Point
Solubility
SUDility
Occanol/vater partition coefficient
Physical State
Density or specilic gravity
. Boiling Point
Vapor preacure
I*
Stoioge ataaility
Floaaabilicy
Oxidising or reducing action
Exploaivenesa
Hiacioility
Viscosity
Corrosion characteristics
Dielectric breakdom voltage
Cage or pan field test
Full-scale field test
Fiea acute LCjg— raiabov trout and bluegill
Acute toxic icy to aquatic invertebrates
Acute toxicity to estuarine and urine
oraaniflna
Short tern emulated field test
Long term suaulated field tast
Acute otal toxicity
Acute dermal toxicity
Acute LonaLation toxicity
Priaary eye irritation
Primary deroal irritation
Oeraal sensitixation
tee« not
required
for ay
Product
Listed
Above
(check
be lew)
I an comply
Data Requiri
Bv
Citing
MR 10 4
i
j
Lng witti
inents
Submitting
Data
(attached)
(cheek below)
I
L
l_
(For BPA
Das Only)
Accession
Numbers
Assigned
-------
Appendix III-L
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Number:.
Registrant's Name:
As an authorized representative of the registrant of the product identified
.above.,. I_hereby_cer.tify that:
(1) I.have.-read and am familiar with the terms of a Notice in a-Guidance
Package from EPA dated concerning a requirement._fqr submission
of generic data on the active ingredient ,
-under-F-1-FPA- Section 3 (c) (2) (B).
(2) My firm requests that EPA not suspend the registration of our. product,
despite'our lack of intent to submit the data in question^ on the grounds
that-the-product-is an end-use product and it contains the'active
ingredient solely, as the result of the incorporation into-the-product
(during formulation or packaging) of a manufacturing-use product which
contains that active ingredient, which is registered under FIFRA Section
3, and which is purchased by us from another producer.
(3) An accurate confidential formula statement for the above-identified
product, is attached to this statement. That formula statement indicates,
by company name, registration number, and product name, the source of the
active ingredient in my firms's product. My firm will apply-for an
amendment to the registration prior to changing the source, .of the active
ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any
portion of this Statement is no longer true, or if my firm fails to comply
with the undertaking made in this statement, my firm's product's
registration may be suspended in accordance with FIFRA Section 3(c)(2)(B).
Dated:
^Registrant.'"s Authorized
Representative:
(Signature)
(Typed)
-------
Appendix III-2
FIFRA § 3 (C) (2) (B) SUMMARY SHEET
EPA Registration No.:
Product Name:
Applicant's Name:
Registration Standard for Products Containing:
Date Registration Standard Issued:
Date Guidance Package Issued:
With respect to the requirement to submit "generic" data imposed by the FIFRA
section 3(c)(2)(B) notice contained in the referenced Guidance Package, I am
responding in the following manner:
Attached is a completed "Generic Data Exemption Statement."
I will submit data in a timely manner to satisfy the following
requirements. If the test procedures I will use deviate from
(or are not specified in) the Registration Guidelines or the
Protocols contained in the Reports of Expert Groups to the
Chemicals Group, CECD Chemicals Testing Programme, I enclose
the protocols that I will use:
I have entered into an agreement with one or more other registrants
under FIFRA § 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be
submitted to EPA by (name of other registrant} .
I enclose a completed "Statement of Willingness to Enter Into An
Agreement With Other Registrants For Development Of Data" with
respect to the following data requirements:
I request that you amend my registration by deleting the following
uses:
I request voluntary cancellation of the registration of this product.
Dated:
Registrant's Authorized
Representative:
(signature)
(typed)
-------
Appendix III-3
STATEMENT OF WILLINGNESS TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
(1) I am duly authorized to represent the following firm(s) who are subject to
the requirements of a Notice under FIFRA Section 3(c)(2)(B) contained in a
guidance package dated to submit data concerning the
active ingredient 5
Name of Firm EPA Company Number
(This firm or group of firms is referred to below as "my firm".)
(2) My firm is willing to develop and submit the data as required by that
Notice, if necessary. However, my firm would prefer to enter into an
agreement with one or more other registrants to develop jointly, or to
share in the cost of developing, the following required items or data:
(3) My firm has offered in writing to enter into such an agreement, and has
offered to be bound by an arbitration decision under FIFRA Section
3(c)(2)(B)(iii) if agreement on all terms could not be reached otherwise.
This offer was made to the following firms(s) on the following date(s):
Firm Date of offer
However, none of those firm(s) accepted my offer.
(4) My firm requests that EPA not suspend the registration(s) of my firm's
product(s), if any of the firms named in paragraph (3) above have agreed
to submit the data listed in paragraph (2) above in accordance with the
Notice. I understand EPA will promptly inform me whether my firm must
submit the data to avoid suspension of its registration(s) under FIFRA
Section 3(c)(2)(B).
Dated:
(Signature)
(Typed)
-------
Chapter U-environmental Protection Aaancy
APPENDIX V-I
§ 162.10
51*2-10 Labeling rcqairaMMt,
(a) Generrt-U) Contents of tfie
label Every pesticide products shall
bear a label containing the informa-
tion specified by the Act and the regu-
lations in this Put. The contents of a
label must show clearly and promi-
nently the following:
(1) The name, brand, or trademark
under which the product la sold as pre-
scribed in paragraph (b) of this sec-
tion:
(11) The name and address of the
producer, registrant, or person for
whom produced as prescribed in pan-
graph of this section.
(2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions. Appear on a clear contrasting
background: and
(C) Not be obscured or crowded.
(3) Language to te toed. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as Is considered necessary to
protect Che public. When additional
text In another language Is necessary.
all labeling requirements wdl be ap-
plied equally to both the English and
other-language versions of the label-
ing.
327
4O.10I O—V
-------
§162.10
(4) Placement of lodel—d) Generai.
The label shall appear on or be secure-
ly attached to the immediate contain*
er of the pesticide product. For pur-
poses of this Section, and the mis*
branding provisions of the Act. "se-
curely attached" *hali nrHT1 that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions provisions concerning the la-
beling. ""if^Tifl1 anri placarding of haz-
ardous Tpat-jTSaia anrt tjjg 7ehicles car-
rying th"^ define the basic Federal
(11] A false or misleading stateo
concerning thp effectiveness of
the
requirements. In addition, when any
registered pestidde product is trans-
ported in a tan IT ear. tank truck or
other mobile or portable bulk ointaln-
er, a copy of the accepted label must
be attached to the shipping papers.
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are stored In bulk containers.
whether mobile or stationary, which
remain in the custody of the user, a
copy of the label of 1ttha"T'ffi including
all appropriate directions for use. shall
be securely attached to the container
In the iTHTnordnra vicinity of th«> dis-
charge control valve.
(5) False or misleading statements.
Pursuant to section 2(qXlXA) of the
Act. a pesticide or a device declared
subject to the Act pursuant to } 162.15.
is misbranded If Its labeling is false or
jjj any particular
both pestteidal *Tf\ uon-peatieidal
fitt
-------
Chapter U-finvironmontai Protection Agency
§ 162.10
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product Is sold
shall appear on the front panel of the
labeL
(2) No name, brand, or trademark
may appear on the label which:
(1) Is false or misleading, or
(11) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to J 162.6(b)(4).
(c) Name and address of producer,
registrant, or person for whom pro*
duced. An unqualified name anr* ad-
dress given on the label shall be con-
sidered as the name and address of the
producer. If the registrant's name ap-
pears on the label and the registrant is
not the producer, or if the name of the
person for whom the pesticide was
produced appears on the label. It must
be qualified by appropriate wording
such as "Packed for • • V "Distribut-
ed by • • V or "Sold by • • •" to show
that the name Is not that of the pro-
ducer.
(d) Net weight or measure of eon-
tents. (1) The net weight or measure
of content snail fie exclusive of wrap-
pers or other materials and shall be
-the average content unless explicitly
stated is 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 semiso-
lld. viscous or pressurized, or Is a mix-
ture of liquid and solid, the net con-
tent statement shall be in terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be
stated in terms of the largest suitable
units, i.e.. "1 pound 10 ounces" rather
than '"28 ounces."
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(8) Variation above minimum eon-
tent or around an average is permissi-
ble only to the extent that it repre-
sents deviation unavoidable In good
manufacturing practice. Variation
below a stated minimum is not permit-
ted. In no case shall the average con-
tent of the packages in a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the time of
registration shall appear on the label.
preceded by the phrase "EPA Regis-
tration No.." or the phrase "EPA Reg.
No." The registration number shall be
set in type of a size and style similar to
other print on that part of the label
on which it appears and shall run par-
allel to it. The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "SPA Sst.". of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the SPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—
-------
§ 16110
THIe 10 Protection of Environment
the labeL If there Is an outside con*
taincr 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 rrio^eo^ 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.
(ill The text of the ingredient state*
ment must run parallel with other
text on the panel on which it appears.
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement. The name used for each in*
gredient shall be the accepted
common name, if there is one. fol-
lowed by the chemical name. The
common name may be used alone only
if it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or propri-
etary name be permitted ™IP»« such
name has been accepted as a common
name by the Administrator under the
authority of Section 23 yQfjT in (h.0 ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible ***fi»fi$nf good manu-
facturing practice. II there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be pres-
ent.
(6) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
(1) 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 lor sale or use after
Cdatel."
(11) The product must meet all label
claims up to the expiration time indi-
cated on the labeL
(7) Inert ingredients. The Adminis-
trator may require the name of any
men 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 lexicological
hazard Including hazard to children.
environmental hazard, and physical or
fHoTMifoi hazard fall Into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement.
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxtaty Catego-
ry of the pesticide. The category Is as-
signed on the basis of the highest
hazard shown by >ny of the indicators
in the table below:
v
CntUh
ftoni 99 «nt 900 ingAq Aon 900IM* 4000 mgf OMMV Mn 9000 mgr
«» "»
Aon J IM 2 mVMr_ FIOH 2.1M 20 mgmv r,im*m «wu a irq/ltm
200 fto»XX «w
rswnaxooa
330
-------
§ 16X10
IV
(1) /Fumon Aasard Jfenai toont—
-------
§ 16X10
TIN* 40 Protection «V Environment
(2) Other required warning* and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ad*
Hazard" and
"Physical or Chemical Hazard."
(1) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required Indi-
cating' the particular hazard, the.
route(s) of exposure and the precau-
tions to be taken to avoid accident.
injury or damage. The precautionary
paragraph «haii be immediately pre-.
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
i by (Booty ffiMQoiy
Taocrty
Oral. MMBtatton. or donra! (BBCrty
Stan 4nd oyo IOCBI effects.
Ftut (pOBonoui) rf •Mttowttf {minted or toioifead throuBR
Mil. Oo noi Bran* war Cdut or «ray mat]. Oo not
aj> « «y«a. anaun. ar onetoMno,
CFioni pmM stumcnt of
May M «• if
Man). Oo not
•y* and slun dmiQa> Cor siui *n»
tnonl. Oo not got in lyo. on itan. or on dam.
ina» wwr oodjQiiB or fact SIMM ind funoor
ouMft wnon hinQUnQ. Hinnful or fiM if imt-
IOWM. CApprepmM Ant art MUomoni nwurad.]
CWMMd or aneroid mrouqn in* Stuart ay* (and itan] nnuen. Oo not 9*1 n cyM.
pen (dun or may nmj. Oo net on Stan, ar on donna. Harmful
-------
Chapter I—€nvironm«ntal Protection Agency
§162.10
(111) Physical or chemical hazards, ity or explosive characteristics of the
Warning statements oa the flammabil- pesticide are required as follows:
MOMittM. 00 nol ounou* or
(1) Directions for Use— <1) Central
equirements— (I) Adequacy and clar-
ity of direction*. Directions for use
must be stated in terms which can be
easily read and understood by the
average person likely to use or to su-
pervise the use of the pesticide. When
followed, directions must be adequate
to protect the public from fraud and
from personal Injury and to prevent
unreasonable advene effects on the
(ill Placement of direction* for use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided thac
(A3 If required by the Agency, such
printed or graphic matter Is securely
attached to each package of the pesti-
cide. or placed within the outside
wrapper or bag:
(B) The label bears a reference to
the directions for use In accompanying
leaflets or circulars, such as "See di-
rections in the enclosed circular" and
(CD The Arfmfaiimjatffr determines
that it Is not necessary for such direc-
tions to appear on the 1n***l
(111) Exceptions to requirement for
direction for use— (A) Detailed direc-
tions for use may be omitted from la-
beling of pesticides which are intended
for use ""ly by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes,
provided that:
(It The label clearly shows that the
product Is intended for use only in
manufacturing processes and specifies
the typets) of products involved.
(.2) Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product involved and its
proper use in manufacturing process-
es:
(Jl The product will not come into
the hands of the general public except
after incorporation into finished prod-
ucts: and
<4) The- Administrator determines
ty^fj. such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
dde products for which sale Is limited
to physicians, veterinarians, or drug-
gists. provided thac
U) The label clearly states that the
product Is for use m*iy by physicians
(.2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(J) The product is also a drug and
regulated under the provisions of the
Federal Food. Drug and Cosmetic Act.
333
-------
§162.10
TllU 40—Protection of Environment
(Q Detailed directions for use may
be omitted from the labeliri ot pesti-
cide products which are Intended for
use only by formulators in preparing
pesticides for sale- to the public, pro*
Tided that:
U) There Is information readily
available to the formulators on the
composition, toxiaty. methods of use,
applicable restrictions or limitations.
and effectiveness of the product for
pesticide purposes;
(2) The label clearly states that the
product Is intended for use only In
manuf?.£turing. formulating, mixing.
or repacking for use as a pesticide and
specifies the type
-------
Chapter I—Environmental Protection Agency
use<3) classified general shall be la*
beled with the exact word- "General
Classification" Immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained in the Directions for Use will be
considered a false or misleading state-
ment 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 clas-
sification on the front panel as de-
scribed below:
(i) Front panel statement of restrict'
ed use classification. (A) At the top of
the front panel of the label, set in type
of the same *""»<"«"»« sizfs as required
for human hazard signal words (see
table in 9leiKKhXIXiv)). and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to make it unlikely to
be overlooked under customary condi-
tions of purchase and use. the state-
ment "Restricted Use Pesticide" shall
appear.
(B) Directly below this statement on
the front panel, a summary statement
of the terms of restriction imposed as
a precondition to registration shall
appear. If use is restricted to certified
applicators, the following statement is
required: "For retail sale to and use
only by Certified Applicators or per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator's certification." If.
however, other regulatory restrictions
are imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertising [Reserved]
[40 PR 28288, July 3. 1975; 40 PR 38329.
Aug. 1. 1979: 40 PR 38571. Aug. 21. 1979. U
amended *x 43 PR 5788. Peto. 9,1978]
335
-------
TABLE D
LABtSLIHQ WIUUlHISMSHra Of TUB VIVHA. AS AMSHDKP lltofec to the baaple labels following)
ITEH
l
2
1
4
5
6A
6u
7
7A
LABEL KI.KHtJtn
Product Mane
Conpany Wane
and Addreaa
Hat Cootanta
KPA tut. Ho.
EPA Ha*. Uo.
IngreiUcinte
Statement
Pound a/Gal Ion
StaLeaiaikt
hunt Panel
Precautionary
tttataMUte
Kaap Out of Reach
ut Children (Child
tlaiard Naming)
1
lAPPLjCABILiTy
(OP BBQUII1EMEHT
1
1
|A|1 Producte
1
1
1
|All Produote
1
1
1
(All Producte
1
1
1
|A11 Product a
1
1
1
|AH Produuta
1
1
I
1
(All Producta
1
1
1
(Liquid producta
(where daaage glwu
Jan Ibe e I/unit
iarea
(All Producta
1
1
1
1
(All Product*
1
1
1
1
1 PLACEMENT OF LABIS L
1
1
Irront panel
1
1
1
(Hone
1
I
I
1
(Hone
1
1
I
|Hone
1
1
(None
1
1
1
I
(rront panel
(
1
(rront panel
n I
1
1
| Pront Panel
1
1
1
1
Irront Panel
1
1
j
PHErBRItBD
Center front
panel
....
CQHJglffB
Motto* front panel (If reglatrant ie not the producer.
or end of label jaunt be qualified by •Packed Cor**1
teat j'Oletrlbuted by •••*, etc.
ttottOB) front panel JHay be In aw trio unit* to addition
or end of label jto II. 8. unite.
teet I
1
front panel Ittuat be In elallar type elie end run
(parallel to other type.
; I
rront panel, lane- (Hay appear on the container Instead
dlataly before or |of the label.
following Heg. No. j
1
Immediately follow- (Text «uat run parallel wltn other
Ing product nane |te«t on the panel.
1
Directly below the
•tain Ingredient*
etatcnunt
1
1
1
1
1
1
|AI1 front panel precautionary
(atateaittnta aiuet be grouped together,
(preferably blocked.
Above elgnal word Note type else requlrenente.
-------
'-2
TABLE E
ITiJH
7U
1C
7o
111
a
•A
HU
BC
LABKI. BI.UUJHT
ttl|xiara on
otnar than front
panal
All products
All Produuta In
Cate^urteu 1, 11,
and 111
'
All Product u
:
, All pranmirlzcd
|iroductai otliara
with Mduh iiuliita
under ISO tf
PI.ACEMBMT Of LAi
RKQillHBU |
front (laiut)
Front panal
Category Ii Froitt
panal unlaaa rater-
ral utatsaienfe la
uaad.
Other ei Qroupad with
•Ida panel precau-
tionary atatenenta
rront panel •
Nona
None
None
Moiia
ML
PHBrBHHISO
Iiuiadlatcly below
Child llasaid Warning
Both In close
pronlailty to al^nal
word
Front panel Cor all
Top or aide of back
panel preceding
Directions Cor Una
Sana aa above
Bane an above
flame aa above
COMHBHTB
Mote type alee r«(|iilreaienta
Huat be grouped under the
headlnga In aa. 6b, and 0a|
Preferably blocked
Huat be preceded by appropriate
algnal word
Environmental hazards Include
bee caution where applicable
-------
TABLE F
IDl
ITEH
9A
»C
IDA
IOC
10U
u.a.
! I.M1EI, BI.EMBHT
Raatrlctad Block
Hlauua atatcEmnt
Ha-enllry
Skalawot
Bloraija and
Dlu|«iaal Ulock
Ulractloua tat Uaa
KPfLICftBILlTV
Or BEQUliJEHEMf
ALL HEOTRICTBD
producie
All producta
All aholliMiatacaiia
• Inhibitor*
All prtxluctu
All piCMlucta
|H.M:EMEMT QM 1^1
JUJQUIHED
Top c«nter of
Croat panel
iMadlatoltf lollOM-
In9 fltataiaent oC
ClauiilCloation or
head of Dlroatlono
lag Ua«
In tha Olr«otlona
Cur Oa«
In the Dlr«otlona
Cur Una
Nona
1EL.
1 PKBrBHHBD
Prefarably blocked
iBowdlatoly «ft«r
MUuua fltatenant
luwdlately bafora
*4>aolfla dlracllona
for uaa or at tlta
and of dlraatlona
for Una
Nona
| COHHEHTfl
1
1 Inoludaa • atateatant of tho
tar»s of taatr lotion.
Tlta WOrdtt, "IIBSTRICTBD UBE
PBSTICIDB* mat ba fldao typa
alia a* algnal word.
Muat ba groupad togather, aad
|>refarably blockad.
llaadlnfl aoiat ba aaaia cypa alia
«a Oilld Uaaard Warning
Hay ba In Mtrlo untta aa wall
aa U.fi. unit*.
-------
rnccAuiONAnv BIAIEMCNIS
HA/AnOS IO HUMANS
|t OOMESIIC ANMAISI
ENVIIONMENf Al MAlAflDS
F1IVSCAL On CMEMCAL
MAIAHO9
RE-ENTRY STATEMENT
(If applicable)
RESTRICTED USE
PESTICIDE
. for rtlill lilt I* «n
-------
SIATEMtNIS
TO HUMANS
|» DOMESTIC ANIMALS)
CAUTION
ENVIRONMENTAL HAZARDS
PHYSICAL on CHEMCAL
HA2AIIOS
DIRECTIONS FOR USE
II « • v-afeion el f •Jw*i hv to UM .
irtk p>M%xl o • mwuio •Kona.iiini
HE
STORAGE AND
SIOIIACE
DISPOSAL =:
, CROP
PRODUCT
NAME
ACTIVE INGREDIENT
«
It
TOTAL.
10000%
CAUTION
STATEMENT OF
IF SWALLOWED:
IF INHALED =
f ON SKM ==
IF IN EVES ==
Set SIDE PANEL FOR ADOfTlON a PRECAUTIONARY STATEMENTS
/"-^ TOVV
(5VesT>
^-^EPA
MFGttV==
TOWN. STATE :
I
NETCONTfTS:
w
THIS PRODUCT CONTAINS IBS OP PER GALLON «I(6B
KEEP OUT OF REACH OF CHILDREN fi(J^
CROP
CROP.
CROP
'CROP
WARRANTY STATEMENT
-------
APPENDIX V - 3
Physical - Chemical Hazards
Criteria
I. Pressurized Containers
Required label Statement
Flash points at or below
20°F; or if there is a
flashback at any valve opening
B.
Flashpoint above 20° and not over
over BO0?; or if the
flame extension is more
than IB inches long at
a distance of 6 inches
from the valve opening.
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.
C. ALL OTHER PRESSURIZED CONTAINERS
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 13G°F
may cause bursting.
II. Non-Pressurized Containers
A. Flashpoint
at or below 20°F
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flashpoint
above 20°F and over
80°F
Flammable. Keep away away
iron heat and open flame
Flashpoint over 80°F
and not over 150°F.
Do not use or store near
heat and open flame.
D. Above 150°F
None Required
-------
162.11
(c) Ute ciauiflcatlcn—<1) Clauiflca-
lion criteria for new registration*-
Except as provided in paragraph (cX4)
of this section, a specific uaeCs) of a
pesticide product not previously regis-
tered shall be classified tot general use
11 each of the applicable criteria set
forth in paragraph (cXlXlMffl) of this
section is met. Otherwise, the product
use greater
th«m 0.2 mg/liten
(D) Is not corrosive to the eye or
causes cornea! opacity reversible
within 7 days:
(B) Is not corrosive to the skin and
causes no more than severe «*<" irrita-
tion within 72 hours: and
(P) Causes under conditions of label
use. or* widespread and commonly rec-
ognized practice of use, only minor or
no discernible subacute, chronic, or de-
layed toxic effects on "*" or other
nontarget organisms from single or
multiple exposures to the product '
ingredients), their their metabolite^),
or degradation productts).
(ill) Outdoor applications. A pesti-
cide usets) Intended for outdoor appli-
cation will be a candidate for general
use classification if it meets the appli-
cable set of criteria set forth Immedi-
ately above for either domestic or non-
domestic application, as appropriate.
and if the pesticide: -
(A) Occurs as a residue Immediately
following application in or on the feed
of a mammalian' species representative
of the species likely -to be exposed to
such feed in amounts equivalent to the
average dally intake of such repre-
sentative species, at levels less than K
the acute oral LOu, measured In mam-
malian test animals as specified In the
Registration Guidelines.
(B) Occurs as a residue immediately
following application in or on the feed
of an avian species representative of
the species likely to be exposed to
such feed in amounts equivalent to the
339
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§142.11
Tlfto 40—Protection of Environment
average daily intake of such repre-
sentative species, at levels 1-ss than ft
the subacute dietary LG. measured in
avlan test animals as specified In the
Registration Guidelines.
(C) Results In a rnn-rimirfn calculated
itration following direct applica-
tion to a 6-inch layer of water less
than vt« the acute LG, tor aquatic or-
ganisms representative of the organ-
isms likely to be exposed as measured
in test animals as specified in the Reg-
istration Guidelines.
(D) The pesticide causes, under con-
ditions of label use, or widespread and
commonly recognized practice of use.
only minor or no discernible adverse
effects on the physiology, growth.
population levels, or reproduction
rates of nontarget organisms, resulting
from exposure to the product ingredi-
ents, their metabolites, or degradation
products, whether due to direct appli-
cation or otherwise resulting from ap-
plication, such as through volatiliza-
tion, drift, leaching or lateral move-
ment in soil
(2) Classification criteria for previ-
ously registered products. All pesticide
products registered by this Agency
prior to October 21, 1974 have been as-
signed a Toxicity Category '[see
§ 162.10(11X1)]. Unless the applicant
for reregistration submits or has sub-
mitted the toxicity data on the prod-
uct use
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r~~ctiyiroiiiii*fltfll Protection Aflency
§162.11
the subacute dietary LC« measured In
avtaa test animals as spedled In the
Registration Guidelines.
(C) Results in & tmmfrimm calculated
concentration following direct applica-
tion to a 8-inch layer of water less
than Ho the acute LC* for aquatic or-
ganisms representative of the orga-
nisms likely to be escposed as measured
in test **«<™»»« as specified in the Reg-
istration Guidelines.
(O) The pesticide causes, under con-
ditions of label use, or widespread and
MMiimaniy recognized practice of use.
only minor or no discernible advene
effects on the physiology, growth.
population levels, or reproduction
rates of oontarget organisms, resulting
from exposure to the product ingredi-
ents, ttwlr metabolites, or degradation
products, whether due to direct appli-
cation or otherwise resulting from the
*ppllrftt1on, such as through volatiliza-
tion, drift. i«
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Appendix V-5
STORAGE AND DISPOSAL STATEMENTS
Storage and disposal statements are based upon the type of container used, and
upon the pesticide which is or was in the container.
1. All products registered for home and/or garden use are exempted from
requirements for other statements if they bear the following:
DISPOSAL
DO NOT REUSE EMPTY CONTAINER.
WRAP CONTAINER AND PUT IN TRASH COLLECTION.
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CONTAINER: METAL
SIZE: LESS THAN 30 GALLONS
CHEMICAL: ORGANIC
STORAGE AND DISPOSAL
1. PROHIBITIONS
DO NOT CONTAMINATE WATER, POOD, OR PEED BY STORAGE OR DISPOSAL. OPEN
DDMPING IS PROHIBITED.
2. PESTICIDE DISPOSAL
PESTICIDE, SPRAY, MIXTURE, OR RINSATE THAT CANNOT BE USED OR CHEMICALLY
REPROCESSED SHOULD BE DISPOSED OF IN A LANDFILL APPROVED FOR PESTICIDES OR
BURIED IN SAFE PLACE AWAY FROM WATER SUPPLIES .
3. CONTAINER DISPOSAL
TRIPLE RINSE (OR EQUIVALENT) AND
OFFER FOR RECYCLING, RECONDITIONING, OR DISPOSAL IN APPROVED LANDFILL OR
BURY IN A SAFE PLACE.
4. GENERAL
CONSULT FEDERAL, STATE OR LOCAL DISPOSAL AUTHORITIES FOR APPROVED
ALTERNATIVE PROCEDURES.
Note: AT MANUFACTURER'S OPTION. EE MAY INCLUDE A STATFMFWP. "P-RTTTON TVS
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CONTAINER: FIBRE DRUMS
SIZE: ALL SIZES
CHEMICAL: ORGANIC
STORAGE AND DISPOSAL
1. PROHIBITIONS
-DO HOT CONTAMINATE WATER, FOOD, OR FEED BY STORAGE OR DISPOSAL.
-OPEN DUMPING IS PROHIBITED.
-DO NOT REUSE EMPTY CONTAINER.
2. PESTICIDE DISPOSAL
PESTICIDE, SPRAY, MIXTURE, OR RINSATE THAT CANNOT BE USED OR CHEMICALLY
REPROCESSED SHOULD BE DISPOSED OF IN A LANDFILL APPROVED FOR PESTICIDES OR
BURIED IN SAFE PLACE AWAY FROM WATER SUPPLIES.
3. CONTAINER DISPOSAL
DISPOSE OF IN AN INCINERATOR OR LANDFILL APPROVED FOR PESTICIDE
CONTAINERS, OR BURY IN A SAFE PLACE.
4. GENERAL
CONSULT FEDERAL, STATE OR LOCAL DISPOSAL AUTHORITIES FOR APPROVED
ALTERNATIVE PROCEDURES SUCH AS LIMITED OPEN BURNING.
Note: AT MANUFACTURER'S OPTION, HE MAY INCLUDE A STATEMENT: "RETURN TO MftNUFACTURER"
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CONTAINED: GLASS
SIZE: ALL SIZES
CHEMICAL: ORGANIC
STORAGE AND DISPOSAL
1. PROHIBITIONS
DO NOT CONTAMINATE HATER, FOOD, OR FEED BY STORAGE OR DISPOSAL. OPEN
DUMPING IS PROHIBITED. DO NOT REUSE EMPTY CONTAINER.
2. PESTICIDE DISPOSAL
PESTICIDE, SPRAY, MIXTURE, OR RINSATE TEAT CANNOT BE USED OR CHEMICALLY
REPROCESSED SHOULD BE DISPOSED OF IN A LANDFILL APPROVED FOR PESTICIDES OR
BURIED IN SAFE PLACE AWAY FROM WATER SUPPLIES.
3. CONTAINER DISPOSAL
TRIPLE RINSE (OR EQUIVALENT) AND DISPOSE OF IN AN APPROVED LANDFILL OR
BURY IN A SAFE PLACE.
4. GENERAL
CONSULT FEDERAL, STATE OR LOCAL DISPOSAL AUTHORITIES FOR APPROVED
ALTERNATIVE PROCEDURES SUCH AS LIMITED OPEN BURNING.
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CONTAINER: METAL
SIZE: LESS THAN 20 GALLONS
CHEMICAL: METALLO-ORGANIC & INORGANIC
STORAGE AND DISPOSAL
1. PROHIBITIONS
DO NOT CONTAMINATE WATER, FOOD, OR FEED BY STORAGE OR DISPOSAL. OPEN
DUMPING IS PROHIBITED.
2. PESTICIDE DISPOSAL
PESTICIDE, SPRAY, MIXTURE, OR RINSATE THAT CANNOT BE USED OR CHEMICALLY
REPROCESSED SHOULD BE DISPOSED OF ACCORDING TO PROCEDURES APPROVED BY
FEDERAL, STATE OR LOCAL DISPOSAL AUTHORITIES.
3. CONTAINER DISPOSAL
TRIPLE RINSE (OR EQUIVALENT) AND DISPOSE OF IN AN APPROVED LANDFILL OR
BURY IN A SAFE PLACE.
.4. GENERAL
CONSULT FEDERAL, STATE OR LOCAL DISPOSAL AUTHORITIES FOR APPROVED.
ALTERNATIVE PROCEDURES.
Note: AT MANUFACTURER'S OPTION, HE MAY INCLUDE A STATEMENT: "RETURN TO
MANUFACTURER."
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CONTAINER: FIBRE DRUMS
SIZE: ALL SIZES
CHEMICAL: METALLO-ORGANIC & INORGANIC
STORAGE AND DISPOSAL
1. PROHIBITIONS
-00 NOT CONTAMINATE WATER, POOD, OR FEED BY STORAGE OR DISPOSAL.
-OPEN DUMPING IS PROHIBITED.
-DO NOT REUSE EMPTY CONTAINER.
2. PESTICIDE DISPOSAL
PESTICIDE, SPRAY, MIXTURE, OR RINSATE THAT CANNOT BE USED OR CHEMICALLY
REPROCESSED SHOULD BE DISPOSED OF ACCORDING TO PROCEDURES APPROVED BY
FEDERAL, STATE OR LOCAL DISPOSAL AUTHORITIES.
3. CONTAINER DISPOSAL
CONSULT FEDERAL, STATE OR LOCAL DISPOSAL AUTHORITIES FOR APPROVED
ALTERNATIVE PROCEDURES.
Note: AT MANUFACTURER'S OPTION, HE MAY INCLUDE A STATEMENT: "RETURN TO
MANUFACTURER."
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CONTAINER: GLASS
SIZE: ALL SIZES
CHEMICAL: METALLO-ORCANIC & INORGANIC
STORAGE AND DISPOSAL
1. PROHIBITIONS
-DO NOT CONTAMINATE HATER, FOOD, OR FEED BY STORAGE OR DISPOSAL.
-OPEN DCMPING IS PROHIBITED.
-DO NOT REUSE EMPTY CONTAINER.
2. PESTICIDE DISPOSAL
PESTICIDE, SPRAY, MIXTURE, OR RINSATE THAT CANNOT BE USED OR CHEMICALLY
REPROCESSED SHOULD BE DISPOSED OF ACCORDING TO PROCEDURES APPROVED BY
FEDERAL, STATE OR LOCAL DISPOSAL AUTHORITIES.
3. CONTAINER DISPOSAL
TRIPLE RINSE (OR EQUILVALENT) AND DISPOSE OF IN AN APPROVED LANDFILL OR
BURY IN A SAFE PLACE.
4. GENERAL
CONSULT FEDERAL, STATE OR LOCAL DISPOSAL AUTHORITIES FOR APPROVED
ALTERNATIVE PROCEDURES.
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APPENDIX V-6
§162.16
Tifiw
§ 162.18 Peidddea reqnirinc special pack-
(a) General This section Implements
Section 2S(c)<3) of the Act. which au-
thorizes1 the Administrator to establish
standards with respect to the package.
container or Trapping In which a pes-
ticide or device la enclosed In order to
protect children and adults from seri-
ous injury or fflness resulting from ac-
cidental digestion or contact with pea-
Uddea or devices regulated by thia
Act.
(b) Definitions. Terms used In this
section *fral1 have the «"^i* meaning
set forth in the Act and In } 162JJ. In
addition, as used in this section:
(1) The term "package" means the
immediate container or wrapping in
which ar|7 pesticide is contained for
consumption, use or storage. "Pack-
age" does not include:
(1) Any shipping container or wrap-
ping used solely for the transportation
of any pesticide in bulk or in quantity
to manufacturers, packers or proces-
sors, or to wholesale or retail distribu-
tors thereof; or
(ill Any shipping container or other
wrapping used by retailers to ship or
deliver imy pestloflfi to ^^^ff^^ifffff
unless it is the only such container or
wrapping.
<2> The term "residential applica-
tion" means application of a pesticide
(other than application by a commer-
cial applicator) directly to humans or
pets or application of a pesticide in, on
or around all structures, vehicles or
Or BnvwofltiMfl*
i associated with the household or
homellfe or non-commercial areas
where children spend time, including.
but not limited to:
(1) Gardens, non-commercial .reen-
houses, yards, patios, houses, pleasure
marine craft, mobile homes, campers
and recreational vehicles, non-com-
CttfltDfll wCS* AOZB0
pools ••"** kennels
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Protection Agency
§162.16
tissue) or causes cornea! Involvement
or Irritation persisting tor 21 days or
more;
(iv) Is corrosive to the skin (causes
tissue destruction Into the dermis
and/or scarring} or causes severe skin
Irritation (severe erythema or edema;
at 72 hours;
(v) Has an acute oral LD« of 1.5 g/kg
or less; or
*^">TT>|ral
and physical characteristics of the
substance will not compromise or in-
terfere with the proper functioning of
the special packaging and that the
packaging will not be detrimental to
the integrity of the product during
storage and use.
(U) The special packaging must con-
tinue to function with the effective-
ness specified In paragraph (d)(2) of
this section for the reasonably expect-
ed lifetime of the package, taking into
account the number of times the pack-
age is customarily opened and closed.
This requirement may be satisfied by
appropriate technical evaluation based
on physical wear and stress factors,
force required for activation, and
other relevant factcrs.
(2) Effectiveness specifications. The
special packaging, when tested by the
method referred to in paragraph (d)(3)
of this section, shall meet the follow-
ing specifications:
(1) Child-resistant effectiveness of
not less than 85 percent without a
demonstration and not less th?" 80
percent after a demonstration of the
proper means of opening the package.
In the case of unit packaging, child-re-
sistant effectiveness of not less than
80 percent.
(II) Adult-use effectiveness of not
less than 90 percent without a demon-
(3) Effectiveness testing procedures.
Standards for special packaging 5h^U
be evaulated for each size of a design
used pursuant to the Consumer Prod-
uct Safety Commission (CPSC) proto-
cols specified In 16 C7R I700.20(a).
(b), (c) and (d).
(e) Submission. The registrant of a
registered pesticide which requires
special packaging shall submit u ap-
plication for amended registration
under J 162.6(bX3). The application
shall Include a certification by the reg-
istrant that the package meets the
standards of i 162.18(d). An applicant
for a new registration shall submit a
certification statement tfc«t the pack-
age meets the standards of } 163J6
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Tttto <0-Protection of Environment
quest, for Inspection and copying pur-
poses or for submission to EPA.
(1) A full description of the package
Including:
(l) A full description of the container
including:
(A) ItS Hlm«*i«riftHj| and
(B) Its compositions! fftng' HHM»h«nJ«m anH
(C) The explicit directions for
proper use of che closure or special
and the placement of these
directions on the package.
(2) A complete copy of the data re-
sulting from the tests conducted in ac-
cordance with S 162.18(d): and
(3) Data dammmtrnting th«» compati*
bflity of the pesticide formulation
with the entire package to determine
that the gfr«mi<«^*i aa,d physical charac*
teristic of the substances will not In-
terfere with the safety and efficacy of
the pesticide and the functioning of
the special package.
(g) Enforcement. Failure to comply
rule by its
dat? renders a pesticide misbnnded
under Section ftqXIXB) of FIFRA.
and Is a violation of Section
12(axl)(E) of FIFRA. Registrants who
violate these sections will be subject to
ernl smd criminal penalties under Sec-
tion 14 of FIFRA.
(Sea. 3 and 29
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