GUIDANCE PACKAGE FOR
REBEGISTRATION OF PESTICIDE PRODUCTS
IN COMPLIANCE WITH
2rEthyl-"l,3:he«inedI6l
REGISTRATION STANDARD
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION DIVISION
WASHINGTON, D.C.
SEPTEMBER 30 r 1980
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GUIDANCE PACKAGE FOR
REBEGISTRATION OF PESTICIDE PRODUCTS
IN COMPLIANCE WITH
2rEthyl-"l,3:he«inedI6l
REGISTRATION STANDARD
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION DIVISION
WASHINGTON, D.C.
SEPTEMBER 30 r 1980
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Table of Contents
Section Page
I. Introduction 1
II. Data Compensation 1
III. Submission of Generic Data under FIFBA 5
IV. Requirement for Submission.-of Product-Specific Data Under
PI?BA 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 Dumber 15
5. Producing Establishment Registration Number 16
6A Ingredient Statement 16
63 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 IS
70 Statement of Practical Treatment 18
7E Referral Statement 13
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Table of Contents (cont'J)
8. Side/Back Panel Precautionary Labeling IS
8A Hazard to Humans and Domestic Animals 18
SB Environmental Hazard 19
3C Physical or Chemical Hazard 19
9. Product Classification 21
9B Omitted 28
9C Misuse Statement 28
IDA Re-entry Statement 28
IOC storage and Disposal Block 28
100 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
PIFSA S (3) (C) (1) (D) 33
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APPENDICES
11-1 Data Compensation Statement: Reregistration
11-2 Product Specific Data Report
III-l Generic Data Exemption Beport
III-2 FIFRA s 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 s 162.10 Labeling Requirements
V-2 Table of Labeling Requirements
7-3 Physical-Chemical Hazards Labeling Statement
V-4 40 CPR § 162.11 Ose Classification
V-5 Storage and Disposal Statements
V-€ 40 CFR S 162.16 Special Packing Requirements
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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 PIFRA Section 3(c)(1)(0) 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 PIFRA Sections
3(0 (1) (D) and 3(c)(2)(0)
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B. A statement acknowledging that if SPA approves your application foe
reregistration, the approval will be based on EPA's consideration of
the following:
1. All the existing "generic" data* which, according to the table,
"Generic Data Requirements for Manufacturing Use and End Dse
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 Standard.
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b. FHRA Section 3(c)(2)(D) provides that you need not furnish
and offer with respect to any "generic" data, if your
product is an end-use product and if 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 fron 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 FIJHA Section 3(c)(l)(D). The various
persons who submitted data listed in the Standard's bibliography
who have not waived their rights to receive offers will be listed
in Tables A, B, or C. You will be required to write those
companies if the data in those tables are required to support
your formulations and uses.
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Companies That May Need to Receive Offer to Pay for §3 (c-). (1)(D)
Union Carbide Corporation
Consumer Products Division
270 Park Ave.
New York, N.Y. 10017
D-Con Company Inc.
225 SummifeiAve.
Montvale, New Jersey 07645
S.C.; Johnson
1525 Howe Street
Racine, WI 53403
McLaughlin Gormely King Company
8810 Tenth Avenue North
Minneapolis, MN 55427
Du Says
901 Iberville Street
New Orleans, LA 70112
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d. You need noe 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 FIF3A 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 Pood, Drug and Cosmetic
Act wnich was a prerequisite to a ?IFRA registration action.
2. Form of the offer: You must furnish each person who is entitled
so 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.
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b. An offer to pay the person compensation, with respect to
approval of your application, to the extent required by
FIP5A Sections 3(c)(1)(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. HEQUI5SMBNT FOR SUBMISSION OP GBSEBIC 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
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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 FIFHA
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 PIFBA 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.
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EPA has concluded that these principles should also apply in tne
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 FIFBA, and
is purchased by the registrant; and
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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 cegistrability 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
(OEC3) 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.
_*/ The Pesticide Registration Guidelines were proposed in two separate
publications. On Ally I, 1978 EPA issued proposed guidelines for product
chemistry, environmental chemistry, and fish and wildlife hazard testing,
43 PR 29696. The Agency published proposed human hazard guidelines on
August 22, 1978, 43 FR 37336.
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Also for certain lands of testing (generally Ecological Effects), EPA
requires the test substance to be a "typical fonnulation," and that in
those cases EPA needs data of that type for each major fonnulation category
(e.g., anulsifiable concentrates, wettable powders, granulars, etc.).
These are classified as generic-data and when needed are specified in
Table A. EPA nay 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 fonnulation, regardless of
Lyut-t o£ formulation, 'prrvfo^h—ar^y^ f^ G <3a<-a ai-o further exolaizieo under
Section IV of this document and are specified in Tables 3 and C at the end
of this Section.
D. Options Available For Complying With Bequirgnents 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 "F1FRA § 3(c)(2)(3) Sunmary 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 IH-1),
2. (a) Notify EPA that you will submit the data, and (b) either submit
the existing data you believe will satisfy the requirenent, 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 n».iide11nes or protocols contained in the Reports
of Expert Groups to the Chemicals Grouo, Organization for Economic
Cooperation and Development (OECD) Chemicals Testing Progi
you rust enclose the protocols you will use.
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3. Notify 2PA that you have entered inta an agreement wits one or
acre otter registrants ta jointly develop (or snare in tae cast
of developing) the data. If you elect this option you oust at
tae sane tiae notify SPA which registrant (s) are parties ta the
agreement. At least one of tae parties ta the agreement oust
respond ta this Notice in the manner specified by paragrapn III
(0)(1) above.
4. ?ile with SPA a completed 'Statement of Willingness to Snter
Inta An Agreement With Other Registrants far Development of
Data* {Appendix II1-3) y.
?I?SA Section 3(c) (2}-(3) authorizes joint development of data by two or
mora registrants, and provides a aeehanism by which parties can cotain an
arbitrator's decision if they agree ta jointly develop data but fail ta
agree on all the terse of the agreement. The statute does not compel any
registrant to agree ta develop data jointly.
In 2?A's opinion, joint data development by all registrants wno are
suo^ect to the requirements ta submit a pertinent item of data, or a
cost-sharing agreement between all such registrants, is clearly in the
puolic interest. Duplication of testing cauld increase casts, tie up
testing facilities* and suaject an unnecessarily large nusoer of aniaals
ta testing.
As noted earlier, 2SA has discretion not ta suspend the registration of a
product when a registrant fails ta submit data required under TITHA
Section 3(c)(2)(3). SPA has concluded that it is appropriate to eoarsise
its discretion net to suspend in ways which will discourage duplicative
tasting. Accordingly, if: (1) a registrant has inforaed us of his
intent ta develop and submit data required by this Notice; and (2) a
second registrant informs SPA that it has made a bena fide offer to the
first registrant ta snare in the expenses of the testing [on teras to be
agreed upon or determined by arbitration under ?I?3A Section
3(0 (2)(3)(iii)] and (3) the first registrant has declined to agree ta
enter into a east-sharing agreement, 2?A will net suspend the second
firm's registration. While the first firm is not required ta agree ta
jointly develop data 2?A is act required ta force the second firm to
engage in economically inefficient duplicative tasting in order ta
maintain its registration.
10
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5. Bequest that Z?A amend your registration by deleting die uses
far which the data are needed.
6. acquest voluntary cancellation of the registration(s) of your
products for which the data are needed.
S. Procedures for Requesting Changes In Testing Methodology and
Extensions of Time
SPA 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.
IS 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 (QECD) Chemicals Testing
Programme, you must submit the protocol foe Agency review prior to
the initiation of the test.
If you want, or think that you will need, more tine 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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IV. REQOiaSMSNT FOR SUBMISSION OP PRODUCT-SPECIFIC DATA UNDER FIFSA
5 3(0 (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 FIPRA section 3 {c)(2)(B) EPA has
determined that you must submit these data to SPA 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 S 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.
j.2
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TABLE A
GENERIC DATA REQUIREMENTS FOR MANUFAfTURDIG-USE AND END-USE PRODUCTS CONTAINING 2-ETIIYL-] . 3-HEXANEDIOL
GUIDELINES
SECTION
163.82-3
163.82-4
163.83-1
163.83-2
163.83-3
163.83-4
163.84-2
through-4
163.85-1
NAME OF TEST
SUBCHRONIC 90-DAY DERMAL
Toxicm
SUECHRONIC INHALATION
TOXICTIY
CHRONIC DERMAL TOXICITY
DERMAL CNOOGENICITY
DERMAL TERATOGENICITY
DERMAL REPRODUCTION
MUTAGENICTTY
METABOLISM
(IDENTIFICATION OF
METABOLITES)
ARE
DATA
REQUIRED?
YES
YES
YES
YES
YES
YES
YES
COMPOSITION
TECHNICAL GRADE OF
flCi'lVE IrajKUjIifU^
TECH. GRADE OF A. I.
TECH. GRADE OF A. I.
TECH. GRADE OF A. I.
TECH. GRADE OF A. I.
TECH. GRADE OF A. I.
TECH. GRADE OF A. I.
TECH. GRADE Off A. I.
MUST APPLICANT
ACKNOWLEDGE
RELIANCE UNDER
FIFRA
3(c)(l)(D)7
NO
NO
NO
NO
NO
NO
NO
BIBLIOGRAPHIC
CITATION
-
-
-
-
-
MUST ADDITIONAL
DATA BE SUBMITTED
UNDER FIFRA 3(c)(2)
(B) .? IF SO, DUE
MIEN?
YES/JOT, '82
YES/ JAN '86
YES/ JAN '86
YES/JUL '82
YES/JAN '85
YES/JUL '82
YES/JAN '83
/I Acute inhalation data are not available. It is, thus, not possible to determine if a subchronic inhalation test is needed. A test may be
required, depending on the results of the acute inhalation test.
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•TABU: B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING 2-ETHYL-l , 3-IIEXANEDIOL
GUIDELINES
SECTION
163.61-3
163.61-4
163.61-5
163.61-6
163.61-7
163. 61-8 (c)(l)
163.61-8(c) (2)
163.61-8(c)(3)
NAME OT TEST
PRODUCT IDENTITY AND
DISCLOSURE OF
INGREDIENTS
DESCRIPTION CF
MANUFACTURING PROCESS
DISCUSSION CM
FORMATION CF
UNINTENTIONAL
INGREDIENTS
DECORATION AND
CERTIFICATION OF
INGREDIENTS LIMITS
PRODUCT ANALYTICAL
METHODS AND DATA
COIOR
ODOR
MELTING POINT
ARE
DATA
REQUIRED?
YES
YES
YES
YES
,
YES
YES
YES
YES
COMPOSITION
EACH PRODUCT
EACH PRODUCT
EACH PRODUCT
EACH PRODUCT
EACH PRODUCT
TECHNICAL GRADE OF
ACTIVE INGREDIENT
TECH. GRADE OF A. I.
TECH. GRADE OF A. I.
DOES KPA HAVE
DATA TO PARTIALLY
OR TOTALLY SATISFY
THIS REQUIREMENT?
NO
NO
NO
NO
NO
NO
NO
NO
BIBLIOGRAPHIC
CITATION
-
-
-
-
-
-
-
-
MUST ADDITIONAL
DATA BE SUBMITTED
UNDER FIFRA 3(c) (2)
(B).? IF SO, DUE
WHEN?
_/l
_A
_/l
_/l
Ji
_/l
_/l
_/l
/I These requirements must be fulfilled by each applicant. Data Eron other applications may not be cited. Therefore, even if the
requirement has been partially or coipletely fulfilled for sane products, no references are given. These requirements must be
filled at the time of registration or rereaintration.
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TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING 2-ETHYL-l . 3-HEXANEDIOL
GUIDELINES
SECTION
163.61-8(0) (4)
163. 61-8 (c) (5)
163. 61-8 (c) (6)
163. 61-8 (c) (7)
163. 61-8 (c) (8)
163. 61-8 (c) (9)
163. 61-8 (c) (10)
163.61-8(c) (11)
NAME OF TEST
SOLUBILITY
STABILITY
OCTANOL/UATER PARTITION
COEFFICIENT
PHYSICAL STATE
SPECIFIC GRAVITY
BOILING POINT
VAPOR PRESSURE
PH
ARE
DATA
REQUIRED?
YES
YES
YES
YES
YES
YES
YES
YES
COMPOSITION
TECHNICAL GRADE OF
ACTIVE INGREDIENT
TECH. GRADE OF A. I.
TECH. GRADE OF A. I.
TECH. GRADE OF A. I.
TECH. GRADE OF A. I.
TECH. GRADE OF A. I.
TECH. GRADE OF A. I.
TECH. GEADE OF A. I.
DOES EPA HAVE
DATA TO PARTIALLY
OR TOTALLY SATISFY
THIS REQUIREMENT?
NO
NO
NO
NO
NO
NO
NO
NO
BIBLIOGRAPHIC
CITATION
-
-
-
-
-
-
-
~
MUST ADDITIONAL
DATA BE SUBMITTED
UNDER FIFRA 3(c) (2)
(B).7 IF SO, DUE
WHEN?
_/l
_/l
_A
^1
Jl
Jl
_/l
_A
/I These requirements must be fulfilled by each applicant. Data from other applications may not be cited. Therefore, even if the
~ requirenent has been partially or completely fulfilled for seme products, no references axe given. These requirements must be
filled at the time of registration or reregistration.
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TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS OONIMNING 2-EniYL-l,3-HEXANEDIOL
GUIDELINES
SECTION
163.81-1
163.81-2
163.81-3
163.81-4
163.81-5
163.81-6
NAME OF TEST
ACUTE ORAL TOXICm
ACUTE DERMftL TOXICITY
ACUTE INHALATION
TOXICITif
PRIMARY EYE IRRITATION
PRIMARY DERMAL
IRRITATION
DERMAL SENSmZATION
ARE
DATA
keultJLKiaj?
YES
YES
YES
YH9
YES
YES
COMPOSITION
EACH PRODUCT OR
SUBSTANTIALLY SIMILAR
PRODUCT
EA.PROD. OR SUBSTAN.
sm. PROD.
EA.PROO. OR SUBSTAN.
SIM. PROD
EA.PROD. OR SUBSTAN.
SIM. PROD.
EA.PROD. OR SUBSTAN.
SIM. PROD.
EA.PROD. OR SUBSTAN.
SIM. PROD.
DOES EPA HAVE
DATA TO PARTIALLY
OR TOTALLY SATISFY
TIIIS REQUIREMENT?
NO
NO
NO
NO
YES
YES
BIBLIOGRAPHIC
CITATION
-
-
-
000004881
000004881
MUST ADDITIONAL
DATA BE SUBMITTED
UNDER FIFRA 3(c) (2)
(B).? IF SO, DUE
WHEN?
YES/JUN '82
YES/JUN '82
YES/JUN '82
YES/JUN '82
NO
NO
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TABLE C
PRODUCT SPECIFIC END-USE PRODUCTS DATA REQUIREMENTS: PRODUCT CHEMISTRY 2-ETHYL-l , 3-HEXANSDIOL
GUIDELINES
SECTION
163.61-3
163.61-4
163.61-5
163.61-6
163.61-7
NAME OF TEST
PRODUCT IDHiriTY WD
DISCLOSURE OF
DESCRIPTION OF
MANUFACTURING PKXJUSS
DISCUSSION ON
FORMATION OF
UNINTENTIONAL
INGREDIENTS
DECLARATION AND
CERTIFICATION OF
INGREDIENTS LIMITS
PRODUCT ANALYTICAL
METHODS AND DATA
ARE
DATA
REQUIRED?
YES
YES
YES
YES
YES
COMPOSITION
EACH PRODUCT
EACH PRODUCT
EACH PRODUCT
EACH PRODUCT
EACH PRODUCT
DOES EPA FIAVE
DATA TO PARTIALLY
OR TOTALLY SATISFY
THIS REQUIREMENT?
NO
NO
NO
NO
NO
BIBLIOGRAPHIC
CITATION
-
-
-
-
MUST ADDITIONAL
DATA BE SUBMITTED
UNDER FIFRA 3(c)(2)
(B).? IF SO, DUE
HI [EN?
n
.A
/i
j\.
.A
/I These requirements must be fulfilled by each applicant. Data from other applications may not be cited. Therefore, even If the
requirement has been partially or completely fulfilled for some products, no references are given. These requirements must be
filled at the tine of registration or reregistration.
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TABLE C
PRODUCT SPECIFIC END-USE PRODUCTS DATA REQUIREMENTS: PRODUCT CHEMISTRY 2-ET1IYL-1 , 3-HEXANEDIOL
GUIDELINES
SECTION
163. 61-8 (c)U)
163. 61-8 (c) (2)
163. 61-8 (c) (7)
163.61-8(c) (8)
163. 61-8 (c)< 11)
163. 61-8 (c) (12)
163. 61-8 (c) (13)
163. 61-8 (c) (14)
163. 61-8 (c) (15)
163. 61-8 (c) (16)
163. 61-8 (c) (17)
163. 61-8 (c) (18)
NAME OF TEST
COLOR
ODOR
PHYSICAL STATE
SPECIFIC GRAVITY
pH
STORAGE STABILITY
FLAMMABILITY
OXIDIZING/
REDUCING ACTION
EXPirsivENESs
MISCIBILITY
VISCOSITY COEFFICIENT
CORROSIVENESS
ARE
DATA
REQUIRED?
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
COMPOSITION
EACH PRODUCT
EACH PRODUCT
EACH PRODUCT
EACH PRODUCT
EACH PRODUCT
EACH PRODUCT
EACH PRODUCT
EACH PRODUCT
EACH PRODUCT
EACH PRODUCT
EACH PRODUCT
EACH PRODUCT
DOES EPA HAVE
DATA TO PARTIALLY
OR TOTALLY SATISFY
THIS REQUIREMENT?
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
BIBLIOGRAPHIC
CITATION
-
_ /
-
-
-
-
-
-
-
-
-
MUST ADDITIONAL
DATA BE SUBMITTED
UNDER FIFRA 3(c) (2)
(B).? IF SO, DUE
HltEN?
_/l
_/l
VI
_/l
VI
_/l
_A
VL
_/l
Vi
Vi
Vi
_/l These requirements must be fulfilled by each applicant. Data from other applications may not be cited. Therefore, even if the
requirement bas been partially or completely fulfilled for some products, no references are given. These requirements must be
filled at the time of registration or reregistration.
-------
TABLE C
GUIDELINES
SECTION
163.81-1
163.81-2
163.81-3
163.81-4
163.81-5
163.81-6
PRODUCT SPECIFIC END-USE PRODUCTS DATA REQUIREMENTS: TOXICOLOGY 2-EnnfL-l , 3-HEXANEDIOL
NAME OF TEST
ACUTE ORAL TOKICITY
ACUTE DERMAL TOKECrTY
ACUTE INHALATION
TOJacmr
PRIMARY EYE IRRITATION
PRIMARY DERMAL
IRRITATION
DERMAL SENSrriZATION
ARE
DATA
REQUIRED?
YES
YES
YES
YES
YES
YES
COMPOSITION
EACH FOFMUIATION
OR SUBSTANTIALLY
SIMILAR FORMUUVTICIN
EA. FORM. OR
SUBSTAN. SIM. FORM.
EA. FORM. OR
SUBSTAN. SIM. FORM.
EA. FORM. OR
SUBSTAN. SIM. FORM.
EA. FORM. OR
SUBSTAN. SIM. FORM.
EA. FROM. OR
SUBSTAN. SIM FOTM.
DOES EPA HAVE
DATA TO PARTIALLY
OR TOTALLY SATISFY
THIS REQUIREMEWT?
NO
NO
NO
NO
NO
YES
BIBLIOGRAPHIC
CITATION
—
-
-
-
_
000004881
MUST ADDITIONAL
DATA BE SUBMITTED
UNDER FIFRA 3(c) (2)
(B).? IF SO, DUE
WHEN?
YES/JUN '82
YES/JUN '82
YES/JUN '82
-
YES/JUN '82
YES/JUN '82
NO
-------
TABLE C
PRODUCT SPECIFIC END-USE PRODUCT!? DATA REQUIREMENTS:
EFFICACY 2-ETt«L-l,3-HEXANEDiaL
GUIDELINES
SECTION
NAME GF TEST
ARE
DATA
REQUIRED?
COMPOSITION
DOES EPA HAVE
DATA TO PARTIAHY
OR TOTALLY SATISFY
THIS REOUIRFMEWr?
BIBLIOGRAPHIC
CITATION
MUST ADDITIONAL
DATA BE SUBMITTED
UNDER FIFRA 3(c)(2)
(B).? IF SO, DUE
WHEN?
HUMANS: Direct
Skin
ADDlication
And Clothlna
MOSCUITOES
YES
MINIMUM OF 20%
ACTIVE INGREDIENT
YES
000001106 000001118 000004868
000001109 000004865 000004873 _/l
000001114 000004866 000004874
000001117 000004867
OR
000001107 000001121 000004890
000001115 000001123 000004892
000001116 000004887 _/3
OR
GS0020005 005000169 005002667
GS0020007 005000170 005002848
GS0020011 005000172 005003262
005000042 005000187 005003263
005000113 005000222 005003265
005000121 005000231 005003266
005000126 005000236 005004864
005000128 C05000280 005006012
005000130 005000284 005006137
005000141 005000299 005006463
005000164 005002395 005006505
005000165 005002493 005011438
005000167
OR
OTHER DATA MAY BE CITED BUT HDUUD
HAVE TO BE SUPPLEMENTED.
MO
_/l D-CON COMPANY
225 SWOT AVE
MCNTVAUE, NEW JERSEY
07645
_/3 UNION CARBIDE CORPORATION
CONSUMER PRODUCTS DIVISION
270 PARK AVE
NEW YORK, NY 10017
/5 S.C. JOHNSON
1525 HOWE STREET
RACINE, WI 53403
-------
TARTJ! C
PRODUCT SPECIFIC END-USE PRODUCTS DATA REQUIREMENTS:
EFFICACY 2-ETIIYL-l,3-IEXANEDIOL
GUIDELINES
SUCTION
NAME OF TEST
ARE
DATA
REQUIRED?
ocMPOsrnoN
DOES EPA HAVE
DATA TO PARTIALLY
OR TOTALLY SATISFY
THIS REQUIREMENT?
BIBLIOGRAPHIC
CITATION
MUST ADDITIONAL
DATA BE SUBMITTED
UNDER FIFRA 3(c)(2)
(B).? IF SO, DUG
WHEN?
HUMANS: Direct
Skin
Application
And Clothing
SAND FLIES
(BITING MIDGES)
YES
PARTIALLY
000001106 _/l
000001107 jf3
000001109
000001112 /2
005000164
005000236
005003263
005002669
YES/JUN '83
STABLE FLIES
YES
MINIMUM OF 20%
ACTIVE INGREDIENT
YES
GS0020005
GS0020011
000001106 _/l
000001107 _/3
000001109
000001112 _/2
000001114 _/l
000001115
000001116 _/3
000001117 /I
000001118 J\
000001121
000001123 _/3
000004865
000004866
000004867
000004868 _/l
000004874
000004892
000004893 _/4
000021737
005000164
005000236
005000268
005002395
NO
TICKS
YES
PARTIALLY
005002666
YES/JUN '83
* SUFFICIENT EFFICACY DATA ARE NOT AVAILABLE TO ESTABLISH A MINIMUM PERCTNTAGE OF ACTIVE INGREDIENT.
MINIMUM LEVEL IS ESTABLISHED.
_/l D-CDN COMPANY
225 SUMMIT AVE
MONTVALE, MEM JERSEY 07645
_/2 DU-SAYS
901 IBERVILLE STREET
NEW ORLEANS, LA 70112
EACH PRODUCT MUS^ BE TESTED UNTIL A
_/3 UNION CARBIDE CORPORATION
CONSUMER PRODUCTS DIVISION
270 PARR AVE
NEW YORK, NY 10017
_/4 MCLAUGHLIN GORMLEY KING COMPANY
8810 TENTH AVENUE NORTH
MINNEAPOLIS, MN 55427
-------
TABLE c
PBOOUCT SPECIFIC END-USE PRODUCTS DATA REQUIREMENTS:
EFFICACY 2-ETHYL-l, 3-HEXANEDIOL
GUIDELINES
SECTION
HUMANS: Direct
Skin
Application
And Clothing
NAME OF TEST
BIACK FLIES
CHIQGER3
FLEAS
ARE
DATA
REQUIRED?
YES
YES
YES
COMPOSITION
MBUWI OF 20%
ACTIVE INGREDIENT
*
•
DOTS EPA HAVE
DATA TO PARTIALLY
OR TOTAIiY SATISFY
TIIIS REQUIREMENT?
YES
PARTIALLY
PARTIALLY
BIBLIOGRAPHIC
CITATION
000001106 J\
000001109
000001112 _/2
000001118 _/l
005000009
005000164
005003264
005003640
005006137
000001112 _/2
005000130
005000299
005002397
000001112 _/2
MUST ADDITIONAL
DATA BE SIEMITTED
UNDER FIFRA 3(c) (2)
(B).7 IF SO. HUE
HI EN?
HO
YES/OUN '83
YES/JXJN '83
* SUFFICIENT EFFICACY DATA ARE HOT AVAILABLE TO ESTABLISH A MINIMtn PERCENTAGE OF ACTIVE INGREDIENT.
MINIMUM LEVEL IS ESTABLISHED.
/I D-COH COMPANY
225 SUWIT AVE
MDNTVALE, NEW JERSEY 07645
_/2 DU-SAYS
901 IBERVILLE Sjl'KUT
MEN ORLEANS, IA 70112
EACH PRODUCT HOST BE
UNTIL A
-------
Your aoolication for registration must include a completed copy of the
fozm entitled "Product-Specific Data Beport" (Appendix n-2), stating the
methods you are using to comply with the product-specific data requirements.
V. Submission of itevised Labeling, Classification, and Packaging Information
The Acrency has determined to require applicants for registration to amend their
product's labeling order to insure that each label (1) contains accurate,
comolete, and sufficient instructions and precautions, reflecting the results
of data concerning the product and its ingredients, and (2) incorporates labeling
fontiai: and terminology which are sufficiently standardized ro 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 n* 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
roust be submitted within 6 months of your receipt of this Guidance Package.
If you fail to submit revised labeling and packaging inforaation complying
with this section, EPA will issue a notice of intent to cancel your registration
under FIF3A § 6(b)(l).
* For Fumarin, the use directions are found in Charter IV of the Registration
Standard.
13
-------
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 toe 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 Sl62.10(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
-------
xxx,* or similar statements as appropriate. See Appendix V-l. [40
CFR 5162. 10(c).]
Item 3. NET CONTENTS - A net content statement is required an 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
S162.10(d)J
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(6)]
15
-------
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 SPA establishment
registration number on the immediate container cannot be clearly read
through such wrapper or container. See Appendix V-l. [40 CFR
5162.10(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
Sl62.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For agricultural liquid
formulations, the pounds per gallons of active ingredient must be
indicated on the label.
16
-------
Item 7. PROMT 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.
"Keep out of Reach
of Children" as
Required
Size of label on Signal Word as Required
front panel in Minimum Type Size
square inches All Capitals
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Item 7A. CHILD HAZABD 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 S162.10(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 5162.10(h)(1)(i)]
6 point
10 point
12 point
14 point
18 point
6 point
8 point
8 point
10 point
12 point
17
-------
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 70. 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 fiont panel. See Appendix V-l. [40 CFR S162.10[h)(1)(iii)l
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The precautionary
statements as listed below must appear togther on tiie 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 S162.10(h)(2)]
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
18
-------
determine if your product should contain the statement: "HAZARD TO
HUMANS & DOMESTIC ANIMALS"
Item 8B. 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 flammability statements.
2. Criteria for declaration of non-flammability. The following criteria
will be used to determine if a product is non-flammable:
19
-------
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°P (177°C) as determined by the method specified in
40 CFR S163.61-8(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 S163.61-3(c)(13)(ii).
ii. There is no flash back; and
iii. The flash point of the non-volatile liquid component is
greater than 350°F (177°C), determined by the method
specified in 40 CFR $163.61-3(0 (13)(i).
3. Declaration of non-flannnability. Products which meet the criteria
for non-flannnability specified above may bear the item
•non-flammable" or "nonflammable (gas, liquid, etc.)" on the label.
20
-------
It nay 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. Hhen 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 FIFHA 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 S162.30 or based on data already available to the Agency, or
(2) indicated certain formulations/uses to be unrestricted based on data
21
-------
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 S162.11(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 $162.10 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 - Ho 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
5162.10(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
-------
ii. Directly below this statement on the front panel, a
summary statement of the terms of restriction snail
appear. Zf 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. Sane But Not All Uses Restricted - If you determine that seme
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
-------
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. Ho product with a use classified for restricted use under
this first phase of reregistration nay be released for
shipment by the registrant or producer after the 120th day
25
-------
after the data 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 reregisttation,
supplemental labeling means:
(i) an adhesive sticker containing the restricted use
statement specified in 40 C?R 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
-------
e. 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
-------
new label nay 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
S162.10(1)(2)(ii)]
Item 10A. RE-SNTSY 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 DSE - Directions for use must be stated in
terms which can be easily read and understood by the average person
28
-------
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 5162.10]
3. 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-5), 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
-------
(3) it meets the toxicity criteria of 40 Cm 182.IS (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:
Franklin D.R. Gee PM-17
Phone No. (703) 557-7028
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
•FXFSA" Section (3)(c)(2)(3) Summary Sheet (Appendix I1I-2) with
appropriate attachments.
30
-------
3. Within 6 months from receipt of this package you must submit:
1. "Application for Amended Pesticide Hegistration" (EPA Fora
8570-11).
2. 'Confidential Statement of Formula" (EPA Form 8570-4).
3. "Data Compensation Statement: Registration" (Appendix II-1).
4. Product Specific Data Report (Appendix II-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
-------
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-tern 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 FIF3A 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 ^registration 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
-------
era
teq.fed tat
9M* «•?. led.
taut
ITMC oat i
Inquired I
I for ar I
IPradon I
lUrad I
Id
1
eapirM vita
teqttnnu
Slew*
n » t lOra
1 Ic
1 (CMC! MOVI
i (For EPA
1 OM oalf)
lU.fl-1
I ProdoR idractuer ud iH«-lmnr» tavndiana I
(Ul I Mucanility
-------
Appendix II-l
DATA COMPENSATION STATEMENT: REREGISTBATIOM
EPA Reg. No.t
Product Name;
Applicant's Name & Address:.
Date of application for reregistration:
Registration Standard foe products containing:.
Date Heregistration Standard Issued:
Date Reregistration Guidance Package Issued:.
In connection with applicant's application for rsregistration 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 EFA'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:
(signaeure)
(typed)
-------
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 certify that:
(1) I nave read and an familiar with the terns of a Notice in a Guidance
Package from EPA dated concerning a requirement for submission
of generic data on the active ingredient
under FIFRA 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 HI-2
FIFBA § 3 (C) (2) (B) SUMMARY SHEET
EPA Registration Nb. :
Product Name: __ __
Applicant's Name:
_ e _ i
Registration g«-gp*«Tri fnr Pmdogfcs Cont-aining;
Date Registration Standard Issued:
Guidance Package Issued: ^^^^^^^^^^^^
With respect to the requirement to submit "generic11 data imposed by the FHEA
section 3{c)(2)(B) notice contained in the referenced Guidance Package, I am
responding in the following manner:
Attached is a ccnroieted "Generic Data Exemption Statement."
2.
I will submit data in a timely manner to satisfy the following
requirements. IS. the test procedures I will use deviate from
(or are not soecified in) the Registration Guidelines or the
Protocols contained in the Reports of Expert Groups to the
Chemicals Group, QECD Chemicals Ttesting Programme, I enclose
the orotocols that I will use:
I have entered into an agreement with one or mare other registrants
under FIFRA § 3(C)(2)(B)(ii) to satisfy the following data
requirements. TSie 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
Renresentative:
(signature)
(ryped)
-------
Appendix III-3
STATEMENT OF WILLINGNESS TO SHEER
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 -{
Name of Firm EPA Company Number
(This firm ar 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:
(2] 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) (BMiii) 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 registrations) 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)
-------
APPENDIX V-I
Chapter I—Environmental Protection Agency
§ 16110
§ 162.10 Labeling requirement*.
(a) General—
-------
§ 16X10
Tltt* 40—Protection 01 Environment
(4) Placement o/ laoeJ—<1) General
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act. "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outsule container through
which the label cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if it is a pan of the package as
customarily distributed or sold.
(11) 7*anJt can and other bulk con-
tainen— 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
miiiicaritng |Q aqy particular including
both pestlddal and non-pestlddal
ciaiinj Examples of statements or rep-
resentations in the l^bfllng which con-
stitute mighnmrflng include!
<1) A false or misleading statement
concerning the composition of the
product!
A false or misleading comparison
with other pesticides or devices:
(v) Any statement directly or indi-
rectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern-
ment:
(vi) The name of a pesticide which
contains two or more principal active
ingredients if the name suggests one
or more but noi all such principal
active ingredients even though the
names of the other Ingredients are
stated elsewhere in the labeling;
(vil) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser.
(vili) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions
(ix) Claims as to the safety of the
pesticide or Its Ingredients. Including
statements such as 'safe." "nonpoison-
ous," "nonlnjunous." ••harmless" or
"nontoxic to humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) "Contains all natural ingredi-
ents":
(B) "Among the least toxic chemi-
cals known"
CO "Pollution approved"
(6) final printed labeling. (1) Except
as provided in paragraph (aX6)(ii) of
this section, final printed i«h»Hng
must be submitted and accepted pnor
to registration. However, final printed
labeling need not be submitted m*m
draft label texts have been provision.
ally accepted by the Agency.
(II) Clearly legible reproductions or
photo reductions will be accepted for
iinn^ipi labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
illoi reproduction Qiuuity*
328
-------
Chapter I—Environmental Protection Agency
(b) Name, brand, or trademark. (1)
The name, brand, or tradeirark under
which the pesticide product is sold
shall appear on the (rant 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 § 162.6(b)(4).
(c) Name and address of producer.
registrant, or person for whom pro-
duced. An unqualified name and 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 che 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 con-
tents. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated v 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-
lid. 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 "26 ounces."
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(6) Variation above minimum con-
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 pan 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 "EPA Est.". of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—<1) Gener-
al. The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active Ingredients must be
designated by the term "active ingredi-
ents" and the inert Ingredients by the
term "inert ingredients." or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the Ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the Ingredient statement.
(2) Position of ingredient statement.
(i) The ingredient statement is nor-
mally required on the front panel of
329
-------
§16X10
TIHo 40—Protection of Envlrc
the label. If there Is an outside con-
tainer or wrapper through which the
ingredient statement cannot be clearly
read, the ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes tt Impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
(11) The text of Che ingredient state-
ment must run parallel with other
text on the panel on which it appears.
and must be clearly distinguishable
from and must not be placed in the
body of other text.
<3) Names to be used, in ingredient
statement. The name used for each in-
gredient shall be the accepted
common name, if there is one. fol-
lowed by the chemical name. The
common name may be used alone only
If it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 2S(c)(6>.
(4) Statements of percentages. The
percentages of ingredients Shan be
stated in terms of weight-to-weight
The sum of percentages of the active
and the inert Ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active Ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be pres-
ent.
(6) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
(I) In cases where it is determined
that a pesticide formulation changes
chemical composition significantly.
the product must bear the following
statement in a prominent position on
the label: "Not for sale or use after
[date]."
(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
inert ingredienus) 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
chemical hazard fall Into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement,
type size, and prominence are given
below.
(1) Retrain* front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
I* « •««**« 50 ftom 50 «» Monaco Fan tOO nu SSOOHig/ QiMHrltaH 8Bte«y
fnmitmi
Fran &lm 3D me/IB OMMT Mn
330
-------
Todcity cateoorlee
Eye effects* . . .
. Corrosive llrraweraibla
destruction of ocular
tlauua) or conical
irrVDlvoncnt or irritation
aersiBtinj far eon than
21 days
Comeal involvoiB.!
or Irritation elearlnf
in 21 day* or I'M*
Cbnml Intpolvimnt
or irritation
clearing in 7 thy*
or l«n
Minimal effccta
cloarlng in leu
than 24 houra
Conceive Itiasea
destruction Into the
tads and/or ecerrlna)
Seven Irritation K
• 72 houra (severe
Moderate Irritation
at 72 noun (ecdenta
Hlld or slight
Irritation at 72
hours (no Irritation
or alight erythema)
(1) Human hazard ngnal toord—
-------
§ 162.10
Tltlo 40—Protection of Environment
(2) Other required warnings 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 Ani-
mals." "Environmental Hazard" and
"Physical or Chemical Hazard."
(!) 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 shall 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 toaoty category
Toncity
QfU.
Skei if* ay* teal effects.
Fatal (poraonoua) if awaDovjed [inhaled of abaorbad tnrauQfi
Hunl. Do net Breatha vapor [dun or spray mat). Do not
oatn vyvSi on alun. or on dottuno/
(Front panel etatament of oracscal treatment roound.1
May b0 fatal it swalbwso [tfiftalod or absoiBod ftrouQn flM
skm). Oo not bmttw vapors [dust or spray mot]. Do not
got m tyes. on Hon. or on dotting. (Appropriate) first aid
Corroaw*. cauMS eye md atan damaoa (or dun nv
UMfl] Oo not pat m ayai. on Hun. or on elom.
rnQ Waar ooQfllai or faca stMld and rubbar
gkwaa «Mn handbng Harmkil or fatal it Mat-
lOMd. lAporopnata Int aO aatemeffl rogund.]
Causa* ay* (and Man) maton. Oo not gal in eyas.
on stun, or on clotnna, Harmful if awaaowod. [Ap-
proonata fnt aid ttatamant raound.)
if SMailOMMd tinliBiBd or absofood ttirouQh ttw
•km). Avoid oreamng vapora [dual or spray mat] Avoid
contact Mtn abn (eyes or dothngj (Approenata hnt ad
statement rewind.]
[No precauttonary nanmama raqundl
contact Mtn alun. eyea or uuinviy In case of
contact mmadataly llusn eyes or skm om pwnty
of mtar. Gat maaeal anamon if mtanon per-
SOB).
[No precautionary atatamanta raqurad.1
of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LCM of 1 ppm or less.
the statement "This Pesticide is Toxic
to Fish" is required.
-------
Chapter I—Environmental Protection Agency
§ 16&10
(ill) Physical or chemical hazards, ity or explosive characteristics of ttie
Warning statements on the flammabil- pesticide are required as follows:
(A) PHtuumao CoHTMNon
Flat) POM « or MM 8T F. if Mm • • nunttck « EmronMy flmraD-. Comma undor praam Koo my tan fn.
my »•*• non-la, works, md Mono uttooo. Do iw puncnn or i
•r. EJOOBTC to umpmnnt OOM130* F may
Flan MMibonar FmdnalOMraO*Poriltho FI-mniMo. Comma moor praam Ka» mn Horn hon, aora.
lumo aiomm • man mm IB n long it • d_anc* md opm Hum Oo net punam or mcmmm oonniwr. Expoan
at 6 n from tno (tarn* to Imp-vim IBM 130* F rray e__« ounmng.
Conura unov praam. Oo not ua or uora naor hat ar opm
II—no Oo not puncun or mamnu com—nor. Em—n to lorn-
130* F nay e
Kan pom
. Koop oMy lam M. ••**. md hand •_••
AboM 201 F «nd m OMT «r F _
ABM or F ma not own SO* F .
L KMO nay nam nut mt General
requirements—
-------
§16X10
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are Intended for
use only by formulators in preparing
pesticides for sale to the public, pro*
vtded that:
U) There is information readily
available to the formulators on the
compositioa toxicity, methods of use.
applicable restrictions or limitations.
and effectiveness of the product for
pesticide purposes:
(2) The label clearly states that the
product is intended for use only In
manufacturing, formulating, mixing.
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts involved;
(J) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered: and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall include
the following, under the headings "Di-
rections for Use":
(1) The statement of use classifica-
tion as prescribed in 162.10(j) Immedi-
ately under the heading "Directions
for Use."
(ii) Immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling."
(iii) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pest(s) associated
with each site.
(v> The dosage rate associated with
each site and pest.
(vi) The method of application, in-
cluding instructions for dilution, if re-
quired, and type(s) of application ap-
paratus or equipment required.
(vii) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(viii) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
Title 40 Protection of Environment
(lx) Specific directions concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements of 40 CFR Part 183. These
Instructions shall be grouped and
appear under the heading "Storage
and Disposal" This heading must be
set in type of the same nilr1"""" sizes
as required for the child hazard warn-
ing (See Table in § 162.10(h)(l)(lv)).
(x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects, such as:
(A) Required intervals between ap-
plication and harvest of food or feed
crops •
(B) Rotational crop restrictions.
(C) Warnings as required against use
on certain crops, animals, objects, or
in or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who Is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(F) Other pertinent Information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(j) Statement of Use Classification.
By October 22.1976. all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (j) (1) and (2) of this sec-
tion. Any pesticide product for which
some uses are classified for general use
and others for restricted use shall be
separately labeled according to the la-
beling standards set forth in this sub-
section, and shall be marketed as sepa-
rate products with different registra-
tion numbers, one bearing directions
only for general use(s) and the other
bearing directions for restricted use(s)
except that, if a product has both re-
stricted use(s) and general useis). both
of these uses may appear on a product
labeled for restricted use. Such prod-
ucts shall be subject to the provisions
of 5162.10(j)(2).
(1) General Use Classification. Pesti-
cide products bearing directions for
334
-------
Chapter I—Environmental Protection Agency
use(s) classified general shall be la-
beled with th« exact wordr "General
Classification" immediately below the
heading "Directions lor 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 US«KS> classified restricted shall
bear statements of restricted use clas-
sification on che franc panei 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 minimum sizes as required
for human hazard signal words (see
table In ! 162.iO(h)(lXiv», 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 (or 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. 1979: 40 PR 32328.
AUK. 1. 1975: 40 PR 3S5T1. All*. 21. 1975. U
amended at 43 PR 5786. Feb. 9. 1978]
335
-------
TABLE [>
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TAULE P
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iTSB 1 IAIIM. ei-UffiHT
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1 h«*«
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I
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• nil or
-------
rilF.CAMIMMAnv BIAICMtNIB
IIAfAIUIil IO IIIIMAII9
IIINIMCSHC MIMAI3)
OAiiorn
f IWIHUIMENIM. MAIAfll)*
nivccAt on ciuunM.
IIMAIIUS
HE-EiriHY STATEMENT
(If
81 OR AGE AND
DISPOSAL
SlUnAIIE •
uinronAt
IMIECIKIIU ron int
• h • •*•*>»» •* »•>•>•< fc- !• M«
«"»•
RESTRICTED U8E
PESTICIDE
tar nU|l tilt U »n4 me tnly ky rirllllH Uppllcdorl
tr rtrient «nJcr |htlr Jl>tcl twptnllloa •^4 »nl» Itr
t* kr Ibt C«illllr4 /trpllctloi1! (trlltl-
PRODUCT
NAME
ACIIVI •miiEiirni-
•itni •miitnciilM
lOIAt:
*
m
loOOdf
IIM rnonioi CIHIIAIIS ins or rinuAiLUd
KEEP OUT OF REACI 1 OF Cl IILOHEN
BiAiiMF.ni or
IIKAIMIIII
rBNMIOWCD;
*»«(AUO==
r on BHII ==
r >ICT(8 =
BIB BUB PAHIl ton AI11IKIMAI rnEVAIIIIOllNIV aiAUMFNIS
liraav:
lomi.aiAii:
5§f3IAmi3MMEIII HO =
IPA ncaainAiKMi no ;
KF.I cnnituiB:
;CD
<
1
1
•
4
JL
f
4
i
<
i
©
©
v?V
©
©
®
\io)
X
cm IP -— •
• •
£.-.•., .- '
CIMN>: •
CIHJT. —
CINIP: __^_- .
WMMIAfHV BIAIIMIHI
-------
PIILCAUIIOMiriV SIAlEMtXIS
IIAJAIIUS IOKUUAIIS
U OOMESIlC AlllUALSl
CAUTION
f I4VIIIONMEUIAL IIAIADOS
PMYSCAL OR CHEMICAL
IIAlAIIOS
* •
H»
OUIECIlONS FOR USE
••ofehon tt f *il»al k» to •»• •
• *IW>M< KCIMIMlfll
HE ENIHV SIAlEMEllI
STORAGE AND
DISPOSAL
SIOIIAflE —-
PlSI'OSAL ;
, CHOP
PRODUCT
NAME
INEHI MCREOlENIft
101 At.
too oat
THIS PnOOUCT CONTAINS IBS Of PEBOAUOH
KEEP OUT OF REACH OF Cl IILDREN
CAUTION
OF pftACicAt
IF SWALLOWED:
VUIIIAIJ:D=:
f Oil SKH =
IF HI EVES =
SEE SUE PANEL fOn ADOIIONa PHECAUIlOMAnV STA1EMCII1S
IOWN SI Alt:
5 fctSfAUUSHUlMl NO ==^==:
EPA ncuisniAiiou no •• r—
HE i couifis:
2
^^^
^-«
CHOP
CftOP.
CHOP
•CHOP.
WAiiiuurv SIAICMENI
-------
APS5HDS V - 3
Physical - Chemical Hazards
Cr iteria
I. Pressurized Containers
Secuired Label Statement
Flash points at or below
20°?; or if there is a
flashback at any valve opening
Flashpoint above 20° and not over
over 80°P; or if the
flase extension is acre
than 13 inches long at
a distance of 6 inches
frcm the valve opening.
Sctrsmely Flammable•
Contents
under pressure. Keep away
frcm fire, sparks, and heated
surfaces. Co not puncture or
incinerate container.
Exposure to temperatures
above 13GP? may cause
bursting.
?lanmable. Contents under
pressure. Keep away frcm
heat, sparks, and
flame. Do not puncture
cr incinerate container.
aeposure to temperatures
above 12G°? may cause
burstinc.
C. ALL OT5SS 555SSOSI7TED COMTAIiOS
Contents under pressure.
Co not use or store near
heat or open flame. Do not
puncture or incinerate
container. Stposure to
temperatures above 120°?
may cause bursting.
11. Non-Pressurized Containers
A. Flashpoint
at cr below 20°?
aetremeiy flammable. Keep
away from fire/ sparks, and
heated surfaces.
B. Flashpoint
above 20°? and over
Flammable. Keep away away
iron heat and open flame
C. Flasnpoint over 80°?
and not over 150°?.
Do not use cr store near
heat and cpen flame.
D. Above 1SO°F
None Secuired
-------
APPENDIX V-4
Orator I—Em
•I Protection A0oitcy
§ 16X11
162.11
(c) Use classification—U) Classifica-
tion criteria for new reyutrations.
Except as provided In paragraph (c)<4)
of this section, a specific use of a
pesticide product not previously regis-
tered shall be classified for general use
if each of the applicable criteria set
forth In paragraph (cXIXiMiii) of this
section is met. Otherwise, the product
use(s) shall be classified for restricted
use unless a review of the labeling pur-
suant to paragraph (c)(3) of this sec-
tion indicates that the product use
may be classified for general use or
the benefits from unrestricted use of
the pesticide outweigh the risks of un-
restricted use of the pesticide. Each of
the separate criteria as set forth below
must be applied for the product use(s)
to be classified unless the formulation.
packaging, or method of use of the
product can reasonably be expected to
eliminate the route of exposure. New
data submitted to support classifica-
tion must conform to the specifica-
tions of the Registration Guidelines.
(1) Domestic application* A pesti-
cide use(s) intended for domestic ap-
plication will be a candidate for gener-
al use classification if the pesticide
formulation:
(A) Has an acute dermal LDH greater
than 2.000 mg/kg;
(B) Has an inhalation LC. greater
than 2 mg/liter
(C) Causes no canteal opacity, or
causes eye irritation reversible within
7 days or less;
(D) Causes no more than moderate
skin irritation within 72 hours:
(E) Has an acute oral LDi. greater
than 1.5 g/kg for the formulation as
diluted for use; and
(F) 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 effects on man or other nontar-
get organisms from single or multiple
exposures to the product ingredientfsX
then* metabolitets). or degradation
product(s).
(ii) Nondomestic application*. A pes-
ticide usecs) intended for nondomestlc
application will be a candidate for gen-
eral use classification if the pesticide
formulation:
(A) Has an acute dermal LDH greater
than 200 mg/kr.
(B) Has an acute dermal LDH greater
than 16 g/kg for the formulation as di-
luted for use as a mist or spray.
(C) Has an inhalation LO« greater
than 0.2 mg/llter.
(D) Is not corrosive to the eye or
causes comeal opacity reversible
within 7 days:
(E) Is not corrosive to the skin and
causes no more than severe skin Irrita-
tion within 72 hours: and
(F) 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 man or other
noncarget organisms from single or
multiple exposures to the product
IngredienUs), their their metabolite(s).
or degradation product(s).
(ill) Outdoor applications. A pesti-
cide use(s) 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 daily intake of such repre-
sentative species, at levels less than ft
the acute oral LD». 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
-------
§162.11
average daily Intake of sueti repre-
sentative species, at levels ITSS than ft
the subaeute dietary LC* measured In
avian test animals as specified in the
Registration Guidelines.
(C) Results In a maximum calculated
concentration following direct applica-
tion to a 8-inch layer of water less
than Via the acute Ld. for 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) Oosst/icatton criteria far prem-
ovsly registered products. All pesticide
products registered by this Agency
prior to October 21.1974 have been as-
signed a Toxiclty Category [see
S 162.10(hXl)J. Unless the applicant
for reregistration submits or has sub-
mitted the toxicity data on the prod*
uct use(s) required in paragraph (cXl)
of this section, the existing Toxicity
Category determinations shall be used
to establish whether the pesticide
use(s) is a candidate for general or re-
stricted use classification. Except as
provided in paragraph (cX4) of this
section, specific use(s> of a product
shall be classified for general use If
the applicable criteria set forth in
paragraph (cX2) (iWiii) of this section
are met. Otherwise, the product use
shall be classified for restricted use
unless a review of the labeling pursu-
ant to paragraph (3) of this paragraph
(c) indicates that the use may be clas-
sified for genera! use or the benefits
from unrestricted use of the pesticide
outweigh the risks of unrestricted use
of the pesticide. Each of the separate
criteria as set forth below must be ap-
plied for the product use
-------
Chaptar I—Environmental Protection Agency
§162.11
che subacute dietary LC. measured ID
avlan test animals as specl'ied IB the
Registration Guidelines.
(C) Results in a niMfammn calculated
concentration following direct applica-
tion to a 6-inch layer of water less
than Via the acute LG. for aquatic or-
ganisms representative of the orga-
nisms likely to be exposed as measured
in test animals as specified in the Reg-
istration Guidelines.
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 the
application, such as through volatiliza-
tion, drift, leaching or lateral move-
ment in soil
(3) Adequacy of label and labeling.
The directions, warnings, and cautions
for any product use(s) not meeting the
criteria set forth in paragraphs (1)
and (2) of this section shall be further
evaluated according to the criteria set
forth below to determine the adequacy
of the label or labeling to prevent un-
reasonable adverse effects on man or
the environment. If these criteria are
met. the labeling for the affected uses
will be considered adequate to prevent
unreasonable adverse effects on the
environment without further regula-
tory restrictions, and the affected uses
will be classified for general use. The
criteria for evaluating labeling adequa-
cy are as follows:
(1) To follow label directions, the
user of a pesticide product would not
have to perform complex operations
or procedures requiring specialized
training and/or experience:
(II) Failure to follow the use direc-
tions in any minor way would result in
minor or no discernible adverse ef-
fects:
(ill) Widespread and commonly rec-
ognized practices of use would not nul-
lify label directions relative to preven-
tion of unreasonable advene effects
on man and the environment:
(iv) The directions do not call for
specialized apparatus. protective
equipment or material unless they
would be expected to be available to
the general public:
(v) Following directions for use
would result In only minor or no dis-
cernible advene effects of a delayed or
indirect nature, such as through bioac-
cumulation, persistence, or pesticide
movement from the original applica-
tion site, on nontarget organisms.
(4) Other Hazard*. Any product
use(s> which meets the general use cri-
teria of paragraph (c) (1). (2). or (3) of
this section shall nonetheless be classi-
fied for restricted use If the Agency
determines that based on human toxi-
cological data (including epidemiolog-
ical studies), use history, accident
data, monitoring data, or such other
evidence as the Administrator identi-
fies the product use(s) may pose a seri-
ous hazard to man or the environment
which can reasonably be prevented by
classification for restricted use.
(5) Other regulatory restrictions.
Any product use(s> classified for re-
stricted use under the provisions above
may be limited to use by or under the
direct supervision of a certified appli-
cator. The Administrator may addi-
tionally or alternatively impose other
restrictions by regulation. Such regu-
latory restrictions may include, but
are not limited to. seasonal or regional
limitations, limitation of use to ap-
proved pest management programs, or
a requirement for monitoring of resi-
due levels after use. and may be uti-
lized to reduce human health and en-
vironmental hazards associated with
persistent, bioaccumulative. or mobile.
or highly toxic pesticides. Any such
regulation shall be renewable in the
appropriate Court of Appeals upon pe-
tition of a person adversely affected
filed within 60 days of the publication
of such regulation in final form.
341
-------
Appendix .V-5
PROPOSED DISPOSAL STATEMENTS
FOR PESTICIDES
PESTICIDE DISPOSAL (all except household)
Pesticide, spray mixture or rinsate that cannot be used according to label
instructions must be disposed of according to Federal, State or local
procedures under the Resource Conservation and Recovery Act.
CONTAINER DISPOSAL
1. Household (all)
Do not reuse empty container (bottle, can, bucket).
Wrap (container) and put in trash collection.
2. Metal (all sizes)
Triple rinse (or equivalent) and offer for recycling or reconditioning, or
dispose of in a sanitary landfill, or by other approved State and local
procedures.
3. Plastic (all)
Triple rinse (or equivalent) and offer for recycling or reconditioning, or
dispose of in a sanitary landfill, or by incineration if permitted by State
and local authorities.
4. Glass (all)
Triple rinse (or equivalent) and dispose of in a sanitary landfill or by other
approved State and local procedures.
5. Fiber drums with liners
Dispose of liners according to approved Federal, State or local procedures
under the Resource Conservation and Recovery Act. If container cannot be
reused*, dispose of in a sanitary landfill or by incineration if permitted by
State and local authorities.
•Manufacturer should replace this phrase with one indicating whether and how
fiber container may be reused.
-------
6. Paper and plastic bags
Dispose of bags according to approved Federal, State 01 local procedures under
the Resource Conservation and Recovery Act.
7. Compressed gas cylinders
Return empty cylinder for reuse (or similar wording).
-------
ATTACHMENT B
REGISTRANTS WITH PESTICIDE PRODUCTS CONTAINING
THE ACTIVE INGREDIENT
2-ETHYL-l,3-HEXANEDIOL
(6-12)
The attached information 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.
-------
(00270)
**** PRODUCT SEARCH LISTING ****
PRODUCT LAflEL FILE OF 6-12 (011001)
PAGE
*REGtSTHANT*
* 000270
*NAMF AND AOORESS*
FARNAM COMPANIES INC
2250 EAST MAGNOLIA
PHOEIlIX, ARIZONA 85036
***********************************
6022MB261
*******************************************
**************** PRODUCT NAME ****************
00091 RIDER GUARD II INSECT REPELLENT SPRAY
* *TYPEI S« REPELLENT OR FEEDING DEPRESSANT
* *TYPEl 77 UNCLASSIFIED
* *FORM| 19 PRE3SUKI7ED LIQUID
*APDATE*
010674
*PH*
17
*OATE*
*TOXICITY*
3
*INGREDIENTS*
011001 25.0000 2-Fthyl-1,3-hexaned)ol
080301 5.0000 N,N-D|ethvl-m«t«-to)u«m|de and other Itomera
**************** PRQOUCT NAME ****************
00125
TOP FORM REPELLENT STICK
*TYPE« st RFPELLEHT OR FEEDING DEPRESSANT
*TYPEt 77 UNCLASSIFIED
*FORMt 10 JMPPtRHATEO MATERIALS
*APDATE*
070366
*PM*
17
*DATE*
0768
*TOXIC!TY*
OMIOOl 55.0000
013302 .6670
(('172(11
057001
063503
2-Ethyl-l,3-h«x«n«deron»t«
.5550 N-Oetyl 61 evcl ohentene dl cspbox tint da
Petroleum df«t4lleta, oils, iolv*nt, or hydrocacbonsf also Parafffnic hydrocarbon*,
1.9430
aliphatic hydrocarbon** parafflnlc
067501 ,3S"0 P
-------
(00327)
02/23/ftl
SEARCH LISTING ***•
PRODUCT IAHEL FILE OF t-t2 -(01100 I )
PAGE
a******************************************
•REGISTRANT* *HAK£ »nn ADDl'tSS*
» 000127 TEXAS PMCHOTM1A71HE COMPANY
P.O. BOX UJOtt
2021 N GROVE SfPEFT
FT WGHIH TX
ft**********************************
8176265008
*•*»*»••*•*«»»*»*••»****«»»***•»•*»***»**•*
*»***»***•»«**** PRODUCT IIAI'.E ***»»****<•*»***
TPC RE-PEL STICK
*TYPft S« REPELLENT OR FEEDING DEPKESSANT
*TYPEl 77 UNCLASSIFIEO
*FORHt 10 IMPREGNATED MATERIALS
•APDATE*
010973
*PN*
n
oOATE*
0173
•TOX1CITY*
01190 I
04100!
06450}
067501
06901)1
•INGREDIENTS*
liutoxypol ypropvlena alvcol
2-EthV1-l,3-he«aned|o1
Petroleum distillate* olle» •olv»nt» OP hydrocarbons | a«o PaPafMnle hydrocirboni*
hydrocarbon*) parafflnic oil
2.0000
1.6UOO
I .nooo Plperenyl huto«ld« ( (buty IcarbUyl ) (b-ppopylplp«renv1 ) ether flOJt and related
compaunria 20Z )
.1000 Pyrethrlng
*****«**•* NUMBER OF PRODUCTS LI9TEDI
-------
(00336)
02/23/61
***» PRODUCT SEARCH LISTING ****
PRODUCT LABEL FILE OF 6-12 (041001)
PAGE
•A*****************************************
•REGISTRANT* *N»ME AND ADDRESS*
* 000336 WALGREEN LARS INC
200 HILMOT RP
DEERFTELDf ILLINOIS 60015
A*************** PRODUCT NAME ****************
00021 HALGREENS INSECT I?EPFLL£NT SPRAY
* «TYPEi so RFPELLCMT OR FEEDING DEPRESSANT
• *TYPEI 77 UHCLA9SIFIED
* *FORM| 19 PRESSURIZED LIOUID
it****************************.******
••A****************************************
*APDATE*
070962
*PM*
17
•DATE*
0367
•TOXICITY*
3
•INGREDIENTS*
041001 20.0000 2-Ethyl-l,3-h«»«nediol
********** NUMBER OF PRODUCTS LISTEDI I
•l-l-l-l-l-l-l-t-l-l-l-l-l-l-l-l-l-l-l-l-l-l-
-------
(00119)
02/23/61
**** PRODUCT SEARCH LISTING ***•
PRODUCT LABEL FILE OF 6-1? (041001)
PAGE
A******************************************
• REGISTRANT* «NAME ADO ADOHESS*
•A*********************************
•it****************************************
000119 CENOL COMPANY
OIV OF BURGESS V IBROCRAF TERS INC
P 0 BOX 177 ROUTE 45 a PETERSON RD
LIBEFTYVILLEr IL 60048
3123626600
•A************** PRQUUCT NAME ***•*«•*••*•*«•*
00073 CEIIOL INSECT REPELLENT
• *TYPEI 54 REPELLENT OR FEEDING DEPRESSANT
* MYPEI 77 UNCLASSIFIED
• *FORM| 19 PRESSURIZED LIQUID
*APDATE*
031753
*PM*
17
*OATC*
0771
•TOXICITY*
S
*INGREOIENTS*
041001 20.0000 2-tthv»-l»3-h«x«ned1o>
071003 .0050 Rotenone
071004 .0150 Cube R«a
-------
(OQTOb)
o?/2i/ni
**** PRODUCT SEARCH LISTING ***•
PRODUCT LABEL FILE OF 6-12 (041001)
PAGE
•REGISTRANT* «MAME AMD AIMil'ESS*
• 000706 UNION CARB10E CORPORATION
SUITE 401
2001 JEFFFPSlJH DAVIS HHY.
ARLINGTON, VIRGINIA 22202
tut********************************
70J872BS55
«*»*»•*•**»***•*****••**********»«*********
« ••**• t»*t*4k*ft* PBOfiUCT HAME ****************
oooit CLAIRE INSECT REPELLENT
* *TVP£i 5« ffCPELLEWT OR
» *TYPEl TT IINCLASSIFIEH
* «FORH| 19 PRESSliniZED LIQUID
ftkPDATE*
010853
*PH*
IT
*DATE«
1064
•TOXTCITY*
1
0«IOOI 2Q.0004 2-Elhyl-l,J-
D7100) .OB50 Rotanon*
971001 .0150 Cube Rasini other thin rotenona
*****««*** NUMBER OF PRODUCTS L18TEDI
•l-l-l-l-
•l-l-l-l-l-l-
-------
(01016)
02/23/ei
**•* PRODUCT SEARCH LISTING ***•
PRODUCT LABEL FILE OF t-iz (omooi)
PAOE
••••**«******»«***»****«*«******«**********
•REGISTRANT* *NAME AND ADDRESS*
**«*«******«*««**«****«****•******«
A******************************************
001016 UNION CARBIDE CORPORATION
AGRICULTURAL PRODUCTS DIVISION
2001 JEFFERSON DAVIS HIGHWAY, SUITE 001
ARLINGTON, VIRGINIA 22202
•****•****»***»* PRODUCT NAPE »*»»**»**»•**»**
00004 2-ETHYL-lr 1-HFXANEDIOL
* •TYPEI so INSECTICIDE AND HITICIDE
* »TYPEI 77 UNCLASSIFIED
* »FORM| 0! TECHNICAL CHEMICAL
*APDATE*
122766
*PM*
17
•DATE*
1272
•TOXICITV*
a
•INGREDIENTS*
OtlOOl 49.999<9 2-Ethyl-l,J-h«x«n«d
-------
(01021)
02/21/91
**•» PRODUCT SEARCH LISTING ***•
PRODUCT LABEL FILE OF 6*12 (OQ100I)
PAGE
A******************************************
'REGISTRANT* *NAME AMD A^DPESS*
* 001021 MCLAUGHLIN GUHH|_EY KING CO
8BIO TENTH AVE NORTH
MINNEAPOLIS,MINNESOTA 55127
***********************************
6125440341
A**************.****************************
**************** PRODUCT NAME ****************
00566 REPELLENT SPRAY MIX FOR PERSONAL USE* F-STBO
* *TYPEI s« REPELLENT OR FEEDING DEPRESSANT
* *TYPEt 77 UNCLASSIFIED
* *FORH| 02 FORHULATION INTERMEDIATE
*APDATE*
070859
«PH*
17
*DATE*
0273
MNGPF.DIENTS*
oaiOOt 75.0000 2-Ethy1-t,3»haxan«d1ol
043302 1.0000 2.3fi,5-BlB(2-butylene)tetrahydra-2>rura1dahyd«
017201 1.0000 Dlpropyl I •octnchoiperonate
057001 u.OOOO ti-Octyl hlcyclohoptene cHcarbonlmlde
»»****»**••***** PRODUCT NAME ****************
PYROCIOE INTERMEOIAIE 6795
*TYPEl 54 RF.PfLLENT OR FEEDING DEPRESSANT
*TYPEl 77 UNCLASSIFIED
*F(1RH| 02 FORMULATION INTERMEDIATE
*APDATE*
061067
*PM«
17
•DATE*
0967
•IMGREDIEMTS*
041001 62.5000 2-Ethy1-1,3-h«»«ned4,5-BtB(2-butylen0)tetrahydra-2-fura1daHyd«
057001 12.5000 N-Octyl bleyclohaptena dicarboxlmlda
********** NUMBER OF PRODUCTS LISTEDl
•l-l-t-l-l-l-l-l-l-l-l.
• l-l-l-
•l-l-l-
• l-l-l-
-------
*••« PHfinilCT SEARCH LISTING *»**
02/2J/8I PRODUCT LABEL FIIE OF 6*13 (041001) PACE 8
***»*».»*«********«*•***«*«**»*«•**»**«**** A********************************** A******************************************
•REGISTRANT* *NAME AND ADDRESS*
* 001193 707 COMPANY
2I2B23Q300
15)0 STILLWELL AVE
BRONX Mt lOdbl
*>«*»*»*»**»**** PllflDUCT NAME A*************** *ARDA.TE* «PH« *DATE* *TOXICITV*
00051 707 INSECT REPELLENT 062762 17 0567 5
* «TYPEI si REPELLENT OR FEEDING DEPRESSANT
» ftTYPEl 77 UNCLASSIFIED
* tFORMi (9 PRESSUHJZEO LIQUID
AINGREDIENTS*
041001 15.0000 2-Ethy)-l,l-he«an«d1o1
04)302 .2500 2,3,4,5-BU(2-butyl«ne)tetrahydro»2*fur«|dohvd«
0'I7201 .2500 Dloropyl < »oe (nehonepenate
OS70U1 1.0000 N-Oetvl bUvcloheptene d1capbo«
-------
(01266)
02/23/HI
*«** PRODUCT SEARCH LISTING *•**
PPOOOCT LABEL FILE OF 6-12 (041001)
PAGE
to*********************************
•REGISTRANT* *NAME ANU ADDRESS*
* Oft 1266 HALTER INTERNATIONAL CORPORATION
••••••••••••••••••••••••••••••••A**********
5043623232
PO BOX 6099
NEW ORLEANS LA 70174
ft*************** PRODUCT NAMF ****************
00060 SHIELD INSECT REPELLENT
* *TYPEI 54 REPELLENT OR FEEDING DEPRESSANT
* *TYPEI 77 UNCLASSIFIED
• *FORH| 19 PRESSURIZED LIQUID
•APDATE*
OS0666
*PM*
17
•DATE*
0872
•TOXICITY*
2
•INGREDIENTS*
028002 10.4200 Dlmvthyl phthalat*
041001 3.9(400 ?-Ethy1-l, J-haxanedtol
046801 4.3700 Butyl 3tfl-d|hydpo-2»2-dl«i«thv1-4-o«o-2H-pvran"6»eaPbo«vl«t»
*»»*********•*•* PRODUCT NAME *»*«*»»»»•**»***
00153 HALTER INTERNATIONAL SHIELD INSECT REPELLENT
* «TYPEI S4 REPELLENT OR FEEDING DEPRESSANT
* «TYPEI 77 UNCLASSIFIED
* «FORH| 19 PRESSURIZED LIQUID
AAPDATE*
05167S
*PH*
17
•DATE*
OS75
•TOXICITY*
3
•INGREDIENTS*
041001 15.0000 2-Ethy1»!,3-haianad|o1
043302 .2000 2,3,4,5-Bie(2-buty1ene)tetrahvdPO-2-fur«td«hyde
047201 .2000 Dlnropyl Isoctnehomeronate
057001 .8000 M-nctyl hievclohepten« d
-------
(01571)
02/21/fll
«*** PROnUCT SEARCH LISTING »•*»
PRODUCT LAHEL FILE OF b-12 (OatOOt)
PAGE
10
A******************************************
•REGISTRANT* *NAMF AND ADDRESS*
* 001574 STANLEY HOME PRODUCTS INC
333 HESTERN AVE
MESTFIELO MA oioes
**•«•**»******** PRODUCT NAME A***************
00026 STANLEY INSECT REPELLENT
• *TYPEl 54 REPELLENT OR FEEDING DEPRESSANT
* *TVPEl 77 UNCLASSIFIED
• *FORM| |9 PRESSURIZED LIQUID
•INGREDIENTS*
041001 20.0000 2-Ethyl-l,3«hexan«(Ho1
•ft*****************************************
U135623631
*APDATE*
021871
*PM*
17
•DATE*
0574
•TOXICITY*
3
*•******•« NUMBER OF PRODUCTS LISTEOl
-------
(01660)
02/21/81
«*** PRODUCT SEARCH LISTING ****
PRODUCT LAPEL FILE OF 6-lZ (011001)
PAGE
11
»»**»«»*»****»t*****»*****»*»»***»***n***»
*RECIsri»ANT* *NAM£ AND ADDRESS*
* 001660 CHEMICAL SPECIALTIES COMPANY INC
51-55 NASSAU AVE
BROOKLYN NY 11322
A**********************************
2123606016
A******************************************
**************** PRODUCT NAME ****************
oooin NOSECT REPELLENT BY ORO
• *TTPEI 5« REPELLENT on FEEDING DEPRESSANT
* *TYPEI 77 UNCLASSIFIED
* «FORHI i6 SOLUTION-READY TO USE
•APDATE*
11Z569
*PN*
17
•DATE*
1164
*TOXICITY«
3
'INGREDIENTS*
026002 18.0000 Olncthyl phthaleta
011001 6.0000 2-Ethyl-l,3-h«xanBd(ol
046BQI 6.0000 Butyl 1»M-d)hvdro-2i2-tHmethv>-1-o»o-2H-pyr«n-6"e«rbo»v1«t•
*»»»*•«*•*»**•** PRODUCT NAME A***************
0005? NOSECT REPFtLENT
* MYPEI 5« HEPELIENT OR FEEDING DEPRESSANT
* »TYPEl 77 UNCLASSIFIED
* »FORM| |9 PRESSURIZED LIQUID
*APDATE*
061068
17
*OATE*
0668
*TOXIC1TV*
3
•INGPEDIENTS*
011001 15.0000 2-Ethyl-l ,3-he»ar»ed)ol
003302 .2000 2,J,«,5-Bt8(2-hufv1«n«)tetr«hydro-2-
-------
(016911
02/23/41
*•** PRODUCT SEARCH LISTING •«•*
PHnoUCT LAREL FILE OF 6«t2 (001001)
PAGE
12
*•*»*•»»»»*««»«*»»**»*•***»*•*•*««•*«*****»
•HEGISTHANI* *N*ME AND AOKUESS*
* 001641 CHEMICAL COMPOUNDING CORP
6HO ELTON AVENUE
RIVERMEAO, NY ll<30|
At************** PRODUCT NAMP *******•*••»*•**
00099 QUIST INSECT REPELLENT STICK
* *TYPEl 54 PEPEL1ENT OR FEEDING DEPRESSANT
• «TYPEl 77 UNCLASSIFIED
* »FORM| |0 IMPREGNATED MATERIALS
tlNGREniEUTS*
011001 65.0000 2-Ethyl-l ,3-hoxonodlol
A**********************************
5167276600
*APOATE*
06206B
• PM*
IT
•DATE*
0668
•TOXICITY*
********** NUMBER OF PRODUCTS LISTEOl
-------
(020061 *»** PRODUCT SEARCH LISTING ****
02/23/81 PRODUCT LABEL FILE Or 6-12 (011001) PAGE 13
•A***************************************** •*»****»•*•****••*****•••********** A******************************************
•REGISTRANT* *NAMF_ AND ADDRESS*
* nosoob GOOD-MAY INSFCTICIDE INC
3125374525
P.O. POX 27b*
"HEELING IL 60000
A*************** PRODUCT NAME **••*«****•••**• *APDATE* *PM* "DATE* »TOXICITY«
00030 GOOD-NAY MOSOUITO REPELLENT oai96o 17 o«67 3
* *TVPEl 54 REPELLENT OR FEEDING DEPRESSANT
• OTYPEI 77 UNCLASSIFIED
* *FORH| 19 PRESSURIZED LIQUID
•INGREDIENTS*
O'MOOt 20.0000 2-Ethy1-l(3-h«ii«nedlo1
********** NUMBER OF PRODUCTS LISTEDl
-------
(03282)
02/25/81
«*** PRODUCT SEARCH LISTING *«**
PRODUCT LABEL FILE OF 6-12 (041001)
PAGE
14
*•***•»»•**»*»»***»*********»»***»•**»***»*
•REGISTRANT* *NAKE AND ADDRESS*
• 003282 D-COM COMPANY JNC
?25 SUMMIT AVFNUE
HONTVALE, M.J. 076(15
ft**********************************
21297241*11
PRODUCT NAME *»•**»•»**•*****
00041 6-t? BRAND INSECT REPELLENT STICK
• UTPEI 5« REPELLENT OR FEEDING DEPRESSANT
• *TYPEl 77 UNCLASSIFIED
» AFORHI 10 IMPREGNATED MATERIALS
•APOATE*
060768
*PM*
17
•DATE*
0668
•TOXICITV*
3
*INGREDIENTS*
041001 6S.OOOO 2-Ethyl-t,3-he«anecHo1
041102 1.5000 ?,3,a,5-e(it2-butyUn«)t«trBhvdro-2«^urald«hvde
057001 .5000 N-Octyl bUyeloheoten* dlcarbo* Imlda
•»»»*****»****** PRODUCT NtHE ****************
6-12 BRAND INSECT RfPELLE^T SPRAY
»TvpEt so REPELLENT OR FEEDING DEPRESSANT
*TYPEI 77 UNCLASSIFIED
*FORHt 19 PRESSURIZED LIUUID
*APDATE*
022170
*PM*
17
*OATC*
0270
•TOXICITV*
J
•INGREDIENTS*
041001 30.0000 2-Ethv1-l,3»he>apecl1ol
*»****»******»*• PRODUCT MAHE **•*••****<*•*•*
00046 6-12 BRAND INSECT REPELLENT TOILETTES
* «TYPEi 5« REPELLENT OR FEEDING DEPRESSANT
* *TYPEl 77 UNCLASSIFIED
* *FDRMI 10 IMPRE.GNATED MATERIALS
*APOATE*
091468
*PN*
17
*OATC*
0568
•TOXICITY*
3
* INCREMENTS*
OUIOOI 46.0000
U43102 t.0500 2.3i'i,5-iHa(2-butvlrne)tetr«hvdro-2-4ura1riehyde
057001 .J5"U M-Octyl hUyelohentene
-------
(01283)
02/23/fll
***» PRODUCT SEARCH LISTING ****
PAGE
IS
"CONTINUE REGISTRANT 003262
PRODUCT,OOOH7 6-12 URAND INSECT REPELLENT TOWELETTES
PRODUCT NAME •••*••«******»«•
ooou7 -6-iZ" INSECT REPELLENT CREAM LOTIOH
* »TYPEI se»r>edlo1
(JR0301 5.0000 N,N»Di«thv1-m«ta-tolueni1d« and other 1iom«ra
**»***»***•*»••• PROOUCT NAME ft***************
6-12 PLUS INSF.CT REPELLENT STICK
*TYPEI 54 REPELLENT OR FEEDING DEPRESSANT
*TVPEl 77 UNCLASSIFIED
•FORMI 10 IMPREGNATED MATERIALS
*APOATE*
120270
kPH*
17
•DATE*
1274
«TOXICITY*
3
•INGREDIENTS*
041001 56.0QOD 2-Ethyl-l,3-he»an«ri1 o 1
000301 9.1000 N,N-DUthyl-meta-«ol(j«r>1d« and eth»r
-------
(03282)
02/21/81
**** PRODUCT SEARCH LISTING ****
PAGE
••CONTINUE REGISTRANT 003282
PRODUCT 00050 b-l? PLUS INSECT REPELLENT STICK
**************** PRODUCT NAME ****************
oooso 6-12 PLUS INSECT PEPFILENT LIQUID
* ftTVPEt 51 REPELLENT en FEEDING DEPRESSANT
• *TYPEl 7» UNCLASSIFIED
* •FORMI 16 SOLUTION.READY TO USE
•APDATE*
012072
*PM*
17
•DATE*
0172
OTOXICITY*
3
•INGREDIENTS*
041001 80.0000 2-Ethv)-l,3-hensnadlol
OBOJOI 10.0000 N,H-Dtethyl-meta»toluamtda and other (sonars
I*************** PRODUCT NAME »**••••«•••»*••*
00051 6-12 PLUS INSECT REPELLENT TOMELETTE
* *TYPEI s« REPELLENT OR FEEDING DEPRESSANT
* 'TYPE! 77 UNCLASSIFIED
* *FORHI to IHPRFRNATED MATERIALS
•APDATE*
032373
*PM*
17
•DATE*
0373
*TOXJCITY*
3
*INGREDIENTS*
041001 38.0000 2-Ethyl-l ,3-haxanacilol
080301 7.7000 N,N-n|«tbv1-i"et«-toluamtde and other 1 sonars
**************** PRODUCT NAME ****************
090S? 6-12 PLUS INSCCT REPELLENT CREAM
* *TYP£l 54 REPELLENT OR FEEDING DEPRESSANT
* *TYPEI 77 UNCLASSIFIED
« *FORM| 16 SOLUTION-READY TO USE
*APOATE*
120572
• PM*
17
•DATE*
0373
*TO>IICITY*
3
•INGREDIENTS*
041001 17,0000 2-Ethy1-l,3-henaned|o1
080301 3.0000 H|N-0(ethyl-mata-toluamlrte and other Isomars
-------
(032821
**»* PRODUCT SEARCH LISTING ***•
02/2J/fl1
PAGE
17
••CONTINUE REGISTRANT 0032*2
PRODUCT 00053 6-12 PLUS INSECT REPELLENT CREAM
**•**»****»»**** PRODUCT MAKE «****•**•*•*•••»
00053 SPORTSMATE PREMIUM INSECT REPELLENT LTOUID
* *TYPEI 54 REPF.LLENT OR FEEDING DEPRESSANT
* »TYPEI 77 UNCLASSIFIED
* *FORMI tb SOLUTION-READY TO USE
•APDATE*
022073
• PM*
17
•DATE*
02T3
•TOXIC1TY*
3
•INGREDIFN1S*
02B002 5.0000 Dimethyl ohthalate
Ofltnoi S.nOQO 2-Ethyl-l,3"hexaned1o1
QU6BOI 5.0000 Butyt 3i<«-dlhydro-2.2-aned4o1
060301 55.0000 H,N-Ptet hyl-meta-tolueMde and other liom«r»
**»••**••••*•*** PRODUCT NAME *»***•«**••*****
00057 SPORTSMATE II PREMIUM TNSECT REPELLENT SPRAY
* *TYPEI si REPELLENT OR FEEDING DEPRESSANT
• *TYPEl 77 UNCLASSIFIED
• *FORN| 19 PRESSURIZED LIQUID
•APDATE*
120274
• PM*
17
•DATE*
0778
•INGREDIENTS*
028002 5.0000 Dimethyl phthalate
-------
(05282) **** PRODUCT SEARCH LISTING **»*
02/25/81 PAOf IB
••CONTINUE REGISTRANT ooszaz
PRODUCT 00057 SPCJH1SMATE II PREMIUM INSECT REPELLENT SPRAY
•INGREDIENTS*
041001 2.0000 2-Elhyl-lf3-he«an«ri1o1
080301 21.0000 N,M-Dlathy1»meta-toluam|de and other Itemera
********** NUMBER OF PRODUCTS LISTED! 12
-------
<0««76)
02/21/01
»*** PRODUCT SEARCH LISTING »*•«
PRODUCT LABEL FILE OF 6-12 (041001)
PAGE
*.*•***•«»********«•*•***»»«***«**•**»*•****
•REGISTRANT* *NAME AND ADDHFSS*
* ooQ4T6 MORTON PHARMACEUTICALS INC
1625 N. HTGHlArlp ST./P.O. BOX B037
MfrtPHIS IN 3AI08
PRODUCT NAME ****************
EUREKA BUG-A-HOO PERSONAL INSECT REPELLENT
«TYPEI 5« REPtLLENT OR FEEDING DEPRESSANT
*TVPEl 11 UNCLASSIFIED
*FORM| 19 PRESSURIZED LIQUID
»*«****»*»**»*»»******»*»****«*•*** ••*»**»**•»«****•*****»*«***•»•«*•***«**»*•
00016
*
9013B6B600
*APD*TE«
062361
*PM*
17
•DATE*
ObTl
*TOXIC1TV*
2
•INGREDIENTS*
328003 12.7700 Dimethyl phthaUto
oaiOOl 3.4600 2-Ethvl«lf3-h>K«n«(11ol
046BOI 1.7700 Butvl 3f
-------
(04622)
02/23/81
**** PRODUCT SEARCH LISTING ***•
PRODUCT LABEL FILE OF 6-12 (OaiOOl)
PAGE
ft**************,****************************
•REGISTRANT* *NAME AND AHDHESS*
* 00««22 S.C. jriHNSOM AND SONS INC
LAW OEPT
J525 HOWE STREET
RACINE, Ml 5J005
A***************************.*******
«1455
-------
(05050)
.*»* PROOUCT SEARCH LISTING • **•
PHOOHCT LABEL FILE OF 6-12 (041001)
CASE
A******************************************
•REGISTRANT* *N*MF AND APD/IESS*
• 005059 WHITCHAVEN PROO COMPANY
P.O. RHX 10
GRAND ISLAND MY 14072
I*************** PRODUCT M«HE ****************
00001 RAFFLE INSECT REPELLENT CLOTH
* *TVPEI 54 REPELLENT OR FEEDING DEPRESSANT
* *FOHN| 10 IMPREGNATED MATERIALS
•»*»•*«»•*•***»•••**»»************»
*APDATE*
061157
17
•OATC*
0567
• ItlGREOIENTS*
041001 67.0000 2-Ethy1-|,3-ha««oed)ol
****•«•**• NUMBER OF PRODUCTS LISTED!
-------
(05360)
02/23/HI
**»» PRODUCT SEARCH LISTING **•*
PRODUCT LABEL FILE DF 6-12 (OQIOOI)
PAGE
22
A**********************************
A******************************************
•REGISTRANT* *NAME AND ADDRESS*
* 005J60 OIXJ-CHfM OF GREENVILLE INC.
HC1X 2B19
GREENVILLE SC 29602
B032U460HO
•ft************** PRODUCT NAHE ***»**»****»»•**
00008 DISECT NEW ROLL-ON INSF.CT REPELLENT
* *TYPti su REPELLENT OR FEEDING DEPRESSANT
* *TVP£| 77 UNCLASSIFIED
* *FORH| 16 SOLUTION-READY TO USE
*APDATE*
122760
*PH*
17
*OATE*
0667
*TOXICITTf*
1
•INGREDIENTS*
011001 75.0000 2»Ethy1-lf 3*h»xanedlol
ft********* NUMBER OF PRODUCTS LISTEDl
-------
(05367)
02/21/81
**** PRODUCT SEARCH LISTING ****
PRODUCT LABEL FILE OF b-13 (ODIOOt)
PAGE
A***.*******************************.********
•REGISTRANT* *NAME AND AOIVKES3*
* 005367 LARSON LAPS INC
•I*********************************
Bl««52fc615
IRWIN nn
ERIE PA 16-505
***********<<«*** PRODUCT NAME «**•*»****•••**»
OOOOl LARSON'S MIST INSECT REPELLENT
* *TYPEI s« REPFLLENT OR FEEDING DEPRESSANT
* »TYP£l T7 UNCLASSIFIED
* *FORH| 19 PPC3SURIZEO LIQUID
•APDATE*
091056
*PH«
17
*DATE*
1067
*TOXICITY*
3
*INr.REDIEriTS*
041001 20.0000 2-Ethvl-1,J-hex«n«d|o1
01TSOI 30,0000
**************** PRODUCT NAME **»*********»*•«
00002 LARSON'S "SCAT-GNAT"
• *TYPEl 5» REPELLENT OR FEEDING DEPRESSANT
* *TYPEl 77 UNCLASSIFIED
* *FORM| 19 PRESSUItlZED LIQUID
•APDATE*
*PM*
17
»DATE*
1067
•TOX1CITY*
3
•INGREDIENTS*
041001 20.0000 j?-fthy l-t, 3-hB* »n«<1|O t
017501 30.0000
PRODUCT
***»**»*•»»*»»*»
LARSON'S HIST SUPEKIPlt BRAND INSECT REPELLENT
»TYPEI s« REPELLENT OR FEEDING DEPRESSANT
*TYPEl 77 UNCLASSIFIEO
*FOf»Mi 19 PRESSURIZED LIQUID
ftAPOATE*
071967
17
•DATE*
1067
•roxrcrrr*
3
•INGREOIFNTS*
041001 33.3333 ?-Ftsv|-|,J
007501 Ib.bbhh Isoprooanol
********** NUMBER OF PRODUCTS LISTFDl
•l-l-l-l-l-l-l-l-l-l-l-l-
•l-l-l-l-l-l-l-
-------
(05756)
**** PRODUCT SEARCH LISTING **•*
PRODUCT LABEL FILE Of 6-12 (041001)
PAGE
24
•REGISTRANT*
* 005756
• NAME AMI; ADDRESS*
GREER HROS
6315 TOHNLIME RO
N TONAMANDA MY 14120
A********************************** *******************************************
*»****»»***•*••* PRODUCT NAME *»»**»*»**•»**»*
00002 GREER REPELLENT HUNDI-CLOTH
* *TYPEI 54 REPELLENT OR FEEDING DEPRESSANT
• «TVPE( T7 UNCLASSIFIED
• «FORM| 10 IMPREGNATED MATERIALS
•APDATE*
OQ2B6T
17
•DATE*
0668
•TOXICITV*
3
•INGREDIENTS*
0410DI 75.0000 2-Ethyl-l,3-hev»nBcHo1
********** NUMBER OF PRODUCTS LISTEDl
•l-l-t-l-l-l-l-l-l-l-l-l-l-
•l-l-l-l-
-------
(05769)
02/23/81
**** PROPUCT SEARCH LISTING *•**
PRODUCT LABEL FILE OF 6-12 (041001)
PAGE
•REGISTRANT*
• 005769
*NAME
ADDRESS*
UNION CARBIDE CORP
HGR BIO PROO HOME «
AUTO
HLDG I OLD SAM HILL RTVER ROAD
TARRYTOWN, NY IOS91
ft******************************************
9KI34520DO
*»*•««***»****** PRODUCT NAME ft***************
00001 6-t2 BRAND REPELLENT LOTION
* *TYPEI so REPELLENT OR FEEDING DEPRESSANT
* *FORMt 16 SOLUTIOH-READV TO USE
MPDATE*
181064
*PM*
17
*DATE*
0668
*TOXICITr*
3
• INGPEDUNTS*
041001 75.0000 2-Ethyl-l,3-heian«dtol
A*************** PRonUCT NAME ft***************
09040 6-12 IMSECT REPELLENT FOAM
* »TYPEt si REPELLENT OR FEEDING DEPRESSANT
* *TYPEi 77 UNCLASSIFIED
* *FORH| ]4 PRESSURIZED LIQUID
*APD»TE*
090166
*PH*
17
•DATE*
0566
•TOKICITIT*
3
«lNGREDieriTS»
1U.OOOO 2-Ethyl-l ,3-hB»«fi«d1ol
**************** PRODUCT NAME ft***************
00051 6-12 9RAHD INSECT RfPELLENT LIOUID/SPRAV FORMULA
* *TYPEI 5« REPELLENT OR FEEDING DEPRESSANT
* *TYPEl 77 ^'CLASSIFIED
* *FORMi 16 SOLUTION-RE&OY TO USE
*APDATE*
013169
*PH*
17
•DATE*
0169
*TOXIClTr*
3
•INGREDIENTS*
041001 40.0000 2-Fthyl-l,i-
********** NUMBER OF PRODUCTS LISTEOl
•l-l-
-------
(07105)
02/23/61
• *** PRODUCT SEARCH LISTING • «*«
PRODUCT LABEL FILE OF 6-13 (041001)
PAGE
26
HA*****************************************
•REGISTRANT* *NAME AND ADDRESS*
* 007405 CHEMICAL PACKAGING CHRP
PO BOX 9947
FT LAUDEPDALE FL 33310
A**********************************
A*************** PRODUCT NAME ****************
00009 CHEHI-CAP INSECT REPELLENT
* *TYPEI 54 REPELLENT OR FEEDING DEPRESSANT
* *TYPE| 77 UNCLASSIFIED
* *FORH| 19 PRESSURIZED LIQUID
•INGREDIENTS*
041001 20.0000 2-Ethvl-l,3-h*xan8«Ho1
*APDATE*
062J62
*PM*
17
*DATE*
OZ79
********** NUMBER OF PRODUCTS LI3TEDI
-------
(086641 **** PPODUCT SEARCH LISTING ****
02/23/91 PHOnUCT LABEL FILE OF 6-12 (001001) PAGE 27
•i***************************************** A********************************** **«*»**»**»*********»•»*****»••***»***»*«*«
•REGISTRANT* *NAME AND ADDRESS*
• 008664 U.S. LINE COMPANY
4135623629
?2 HAIH STREET
WESTFIELO, MA otons
***«***««•****** PRODUCT NAME •»•******•**•*** «APDATE* *PM* »DATE* *TOXICITr*
flOOOl U. S. SCAT-R-BUG INSECT REPELLENT |OI668 17 1168 2
» *TYPEI so REPELLENT OR PEEPING DEPRESSANT
* *TYPEl 77 UNCLASSIFIED
* *FORM| 14 PRESSURIZED LIQUID
MNGREDIENTS*
041001 20.0000 a-Ethyl-l,3-heiianed1o1
•***•***** NUMBER OF PRODUCTS LISTEDl
-------
(09237)
02/23/H1
*••* PRODUCT SEARCH LISTING **»*
PRODUCT LABEL FILE OF 6-12 (041001)
PAGE
•****»»*«*»********•**»**«•*****•••********
•REGISTRANT* *NAME AND ADDRESS*
» 009237
***********************************
*•••**•*•*•***********«•*••****••*••*******
GUARDIAN CHEMICAL COMPANY DIV - JI PICHHAN COMPANY
2138701921
atfct Rcnriono AVE.
LOS ANGELES. CA 90066
**************** PRODUCT tIAME **«*•*«**••**»•*
00006 GUARDIAN POOL HEAT HUH INSECT REPELLENT
» *TYPEI 5« REPFLLENT OR FEEDING DEPRESSANT
* *TYPEI 77 UNCLASSIFIED
* *FORH| 16 SOLUTION.READY TO USE
•INGREDIENTS*
001508 12.0000 C«tyt alcohol
041001 10.0000 2-Ethvl-l»3-
*APDATE*
*PM*
17
•DATE*
0069
•TOXICITY*
3
********** NUMBER OF PRODUCTS LISTED!
•l-l-l-l-l-l-l-l-l-l-l-
-------
(09BS2)
02/23/81
*•** PRODUCT SEARCH LISTING **••
PRODUCT LABEL FILE OF 6-12 (001001)
PAGE
A******************************************
•REGISTRANT* *NAME AND ADDRESS*
* 009B52 RITE OFF, INC.
1545 STH INDUSTRIAL COURT
BAYSHOHE, MEN YORK 11706
A*******************.*******.********
5166656868
**************** PRODUCT NAME ****************
00012 RITE-OFF TRIPLE-MIX INSECT REPELLENT
• *TYPE« 50 REPELLENT OR FEEDING DEPRESSANT
» *TYPEI 77 UNCLASSIFIED
• *F()RM| 19 PRESSURIZED LIQUID
*APDATE*
120572
*PM*
17
«DATE*
1272
*TOXICITY*
3
•INGREDIENTS*
026002 12.7700 Dimethyl phthalata
041001 3.0600 2-Ethy1-lf3-h«xanedlol
046ROI 3.7700 Butyl 3,1-dihydro-2,2-d
-------
APPENDIX V-6
§162.16
§ 162.16 Potieida requiring special pack.
aging.
(a) General This section implements
Section 2S(c>(3) of the Act, which au-
thorizes the Administrator to establish
standards with respect to the package.
container or wrapping In which a pes-
ticide or device Is enclosed in order to
protect children and adults from seri-
ous injury or illness resulting from ac-
cidental ingestlon or contact with pes-
ticides or devices regulated by this
Act.
-------
Chapter I—Environmental Protection Agency
§ 162.16
tissue) or causa corneal involvement
or Irritation persisting for 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 noun:
(v) Has an acute oral IA* of L5 g/kg
or less; or
(vt) Has such characteristics that
based upon human toxicoioglcai data.
use history, accident data or such
other evidence as is available, the Ad-
ministrator determines that there is a
serious hazard of accidental Injury or
illness which special packaging could
reduce.
(3) Exemptions. Upon the request of
a registrant or applicant the Adminis-
trator may on a case-by-case basis,
grant an exemption, based on support-
ing data accompanying the request
for products for which special packag-
ing is not technically feasible or tor
those pesticides for which the hazards
indicated by the toxfcity criteria in
paragraph -
EHJU REGISTER and shall be applicable
to any product with identical or sub-
stantially similar composition and in-
tended uses.
(4) Urut packaging. Pesticides re-
quiring special packaging and which
use unit packaging st"*1? either pack-
age each unit package in a special
package or use special packaging for
the retail container which contains
unit DBTltaF^ Special packaging will
not be required for both the outer con-
tainer and the unit packages i.1*1**""*!
on a case-by-case basis, further infor-
mation shows that it is necessary for
hazard reduction.
Cd) Sta.ntla.Td3 for special pocfcap-
ing—<1) General reomrements. (1) The
special packaging must continue to
function with the effectiveness specifi-
cations set forth in paragraph (d)<2) of
this section when in actual use as a
pesticide container. This requirement
may be satisfied by appropriate scien-
tific evaluation of the compatibility of
the substance with the special packag-
ing to determine t*"** the chemical
and physical characteristics of Che
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.
(ill The special packaging must con-
tinue to function with the effective-
ness specified hi 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 factors.
{2} Effectiveness specifications. The
special packaging, when tested by the
method referred to in paragraph and (d).
with the application for registration.
(f) Record keeping. The applicant or
registrant of a pesticide for which spe-
cial pngl"tg
-------
TiffM 40^"rFoMcnon of EfiviraniiMfit
quest, for inspection and copying- pur-
poses or for submission ro SPA.
(1) A full description of toe package
(i) A full description of the container
Including:
(A) Its diman«l»miy and
(B) Its nmtpmittmuB and
(11) A full description of the closure
or special package. II appropriate, in-
cluding:
(A) The name of Its manufacturer.
(B) The manufacturer's designation
(title) for the special packaging do*
sure or the physical working of the
ffpwrliil packaging ww^hMMm^ and
(C) The explicit directions for
proper use of the closure or special
packaging nnrl 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! 162.16(d): and
(3) Data
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