GUIDANCE FOR THE REREGISTRATION
OF MANUFACTURING-USE
AND CERTAIN END-USE PESTICIDE PRODUCTS
CONTAINING BARIUM METABORATE (011101)
AS THE ACTIVE INGREDIENT
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, DC 204060
July 1, 1983
EPA/540-RS-83-006
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Table of Contents
Section Page
I. Introduction 1
II. Regulatory Position. ...... 3
III. Requirement for Submission of Generic Data 7
IV. Requirement for Submission of Product-Specific
Data . 13
V. Submission of Revised Labeling and Packaging
Information16
A. Label Contents ................... 16
1. Product Name 16
2. Company Name and Address 16
3. Net Contents 16
4. Product Registration Number 17
5. Producing Establishment
Registration Number 17
6A Ingredient Statement 17
6B Pounds Per Gallon Statement. .......... 17
7, Front Panel Precautionary Statements 17
7A Child Hazard Warning Statements. ........ 18
7B Signal Word 18
7C Skull and Crossbones and Word Poison 18
7D Statement of Practical Treatment ... 18
7E Referral Statement 18
8. Side/Back Panel Precautionary Labeling ..... 18
8A Hazard to Humans and Domestic Animals. 19
8B Environmental Hazard . 19
8C Physical or Chemical Hazard 19
9 Misuse Statement 20
1QA Storage and Disposal Block ........... 20
1 OB Directions for Use . 20
B. Collateral Information ......... 20
VI. Instructions for Submission. 21
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APPENDICES
11-2 FIFRA §3{c)(2)(B) Summary Sheet - EPA Form 8580-1 . . 25
II-3 Certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data
EPA Form 8580-6 26
III-1 Product Specific Data Report (End-Use Products) ... 27
IV-2 Table of Labeling Requirements 29
IV-3 Physical/Chemical Hazards Labeling Statement 32
IV-5 Storage and Disposal Instructions 33
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I. INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) Section 3(g), as amended in 1978, directs the Environ-
mental Protection Agency (EFA) to reregister all currently
registered products as expeditiously as possible. Each regis-
trant of a currently registered product who wishes to continue
to sell or distribute that product in commerce must apply
for reregistration.
This guidance document sets'forth certain of the require-
ments for registration and reregistration of all manufac-
turing-use products (MPs) containing the subject chemical as
the sole active ingredient, These requirements include:
that certain scientific data be submitted and that certain
standards of tox ic ity, composition, labeling, and packaging
be met. Registrants of MPs are referred to all Sections and
Tables for specific information regarding their responsibili-
ties under this guidance document.
This guidance document also sets forth the data require-
ments for those end-use products which contain the subject
active ingredient and for which the source of that active
ingredient is (1) not registered with EPA or (2) produced by
the registrant's firm, or a firm which has ownership in
common with the registrant's firm, or (3) both (1) and (2).
Registrants of such end-use products can exempt themselves
from these requirements if they change their source of supply
to a registered source, provided the source (i.e., registered
active ingredient product) is obtained from a firm that does
not share ownership in common with the registrant's firm.
(If the end-use product registrant decides to switch sources,
a new confidential statement of formula, EPA Form 8570-4,
must be submitted to the appropriate Product Manager within
90 days of receipt of this guidance document.) Registrants
of affected end-use products are referred to only Sections
II, III, and VI and Table A for spec if ic information regard ing
their responsibilities under this guidance document.
It should be noted that end-use products containing the
subject active ingredient will not be reregistered at this
time. Any necessary labeling changes will be implemented
under the Agency's Label Improvement Program at a future
time.
EPA will issue a notice of intent to cancel or suspend
the registration of any currently registered product if the
registrant fails to comply with the requirements set forth
in th is guidance document and w ith the requirements contained
in subsequent information from EPA about compliance with
certain data support requirements.
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This guidance document has been prepared to provide regis-
trants with specific information on how they may reregister
their manufacturing-use products or maintain their end-use
products' registration, (Refer to the cover letter's attach-
ment 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 registra-
tion requirements in this document, please notify the Product
Manager named in the cover letter, within 90 days from the
receipt of this document, that you wish to voluntarily cancel
the registration(s}. If you decide to maintain your product
registrat.ion(s) , you must provide the information described
in the following pages within the timeframes outlined.
Registrants are reminded that Section 6(a)(2) of FIFRA
requires you at any time to submit factual information raising
concerns of possible unreasonable adverse effects of a pesti-
cide. You should notify the Agency of interim results of
studies in progress if those results show possible adverse
effects.
This guidance document will be supplemented by EPA with
additional information about compliance with data support
requirements. In Monsanto v. Administrator, EPA was recently
enjoined by the District Court for the Eastern District of
Missouri from implementing in any way the "mandatory data
licensing" aspects of §3(c)(l)(D) of FIFRA. EPA is assessing
the implications of the injunction for the reregistration
process. Because this situation is currently unresolved,
EPA has decided to proceed with the requirements in this
guidance package which do not relate to the "data licensing"
issue and to supplement the package with additional guidance
when circumstances permit.
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II. REGULATORY POSITION AND RATIONALE
A. INTRODUCTION
Hi is chapter describes the regulatory position of the Environmental
Protection Agency ("the Agency") on barium metaborate, based on an
evaluation of all registered manufacturing-use products (MUPs) containing
barium metaborate as the sole active ingredient. Future requests for
registrations of substantially similar products will be covered by this
standard. This document provides the rationale for the Agency's position
and the criteria for registration. It also discusses labeling requirements.
B. USE PROFILE
Barium metaborate is registered with the Agency in only one Manufacturing
Use Product, BUSAN-11-M1. The Office of Pesticide Programs' Internal
Control Number (EPA Shaughnessy Number) for barium metaborate is 011101,
while its CAS number is 1370-59-2.
Barium metaborate is a broad spectrum killer of bacteria, fungi, and
other micro-organisms. It is used as a preservative in paper coating
formulations to protect paper products from microbiological degradation
during storage. It is also used in paints and coatings. At higher
concentrations it is used to impart mold resistance to coated paper and
paper board. It has been allowed for use in the manufacture of paper and
paperboard under U.S. Food and Drug Administration Regulations 21 CFR
176.180, "components of paper and paperboard in contact with dry food."
There are many nonpesticidal uses on the BUSAN 11-Ml labels which are not
regulated by the Agency, such as fire retardants, antioxidants, and others.
C. REGULATORY POSITION
Based on a review and evaluation of all available data and other relevant
information on barium metaborate the Agency has made the following determinations:
1. Manufacturing-use pesticide products containing barium metaborate as
a sole active ingredient may be registered for sale, distribution,
formulation, and use in the United States, subject to the terms and
conditions specified in this standard. Applicants having products
not conforming to this standard must apply to amend the document so
those products containing barium metaborate may be registered and
reregistered. Mixtures and end-use products containing barium
metaborate may not be registered or reregistered under this standard.
However, the use patterns of the end-use products are considered for
purposes of determining generic data requirements for barium metaborate.
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2. Available data do not shew that any of the risk criteria listed in
Section 162.11(a) of Title 40 of the U.S. Code of Federal Regulations
have been met or exceeded for the uses of barium metaborate specified
in this standard.
3. Registrants must provide or agree to develop additional data, as
specified in the tables attached to this standard, in order to maintain
existing registrations or to permit new barium metaborate registrations.
4. The potential for barium metaborate to affect dry foods is adequately
regulated by the U.S. Food and Drug Administration under Regulation
21 CFR 176.180, "components of paper and paper board in contact with
dry food." There is no need for EPA regulation in this area.
D. REGULATORY RATIONALE
The Agency has determined that it should allow the registration of barium
metaborate to continue for existing use patterns for the following reasons:
1. While little data is available concerning barium metaborate, the Agency
believes it is reasonable to infer that the likely human hazards arising
from the use of barium metaborate are probably minimal. This decision
is based upon the following points:
a. We do not believe the use of barium metaborate on paint will result
in significant human exposure. All end uses of barium metaborate
are incorporated into coatings used on surfaces, i.e., paints or
coatings on paper or paper board, which minimizes human exposure.
Several indoor use sites which might expose young children (schools,
public buildings, hospitals, and domestic housing) are in the
process of being voluntarily removed from the label by the registrant.
Any application for registration of an indoor use site which might
expose children must be accompanied by sufficient justification
and/or data to demonstrate that human exposure is insignificant.
b. While minimal information is available concerning barium—in the
form of its salts—there is no evidence to indicate that barium
salts present any chronic hazard.
c. Considering the chemical nature of barium metaborate, it is reasonable
to conclude that the probable vapor pressure is slight and thus any
exposure due to inhalation is likely to be minimal.
2., The Agency has adequate acute toxicity data on barium metaborate for
regulatory purposes. However, one acute study, an acute inhalation
LC50, is outstanding and constitutes a data gap to be filled. Long
term toxicology studies have been waived because significant or repeated
exposure is not expected due to the registered use patterns.
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3. The available data on the environmental fate and ecological effects of
barium metaborate used in coatings is minimal. However, due to the
minimal potential for exposure to the aquatic environment from barium
metaborate sealed in paint coatings, data requirements in these areas
have been waived.
4. It is not the Agency's policy to cancel or to withhold registration
merely because data are missing or inadequate (see sections 3(c)(2)(B)
and 3(c)(7) of the FIFRA). Rather, publication of this standard provides
a mechanism for identifying data needs, and registration under the
standard allows for the upgrading of labels during the period in which
the required data are being developed. These data will be reviewed and
evaluated when they are received and the Agency will determine at that
time whether they will affect the registration(s) of barium metaborate.
E. CRITERIA FDR REGISTRATION UNDER THIS STANDARD
All products which contain barium metaborate as the sole active ingredient are
subject to this standard and must either comply with the acute toxicity limits,
product composition, and use patterrns requirements listed in Section F of this
document or submit data and a justification to amend the standard to encompass
such products.
The applicant for registration or reregistration of products subject to this
standard must comply with all terms and conditions described in it, including
committing to fill data gaps on a schedule agreed to by both this Agency and
the applicant, and when applicable, offering to pay compensation for data to
the extent required by section 3(c)(1)(D) of the FIFRA. Applicants for
registration under this standard must follow the instructions contained in this
guidance package and complete and submit the appropriate forms within the time
specified.
F. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
Technical grade products must contain at least 90 percent barium metaborate as
the sole active ingredient (calculated as BaB204.H2Q> Each manufacturing-use
product must be fully described with an appropriate certification of limits.
In addition, the active ingredient found in the manufacturing-use barium
metaborate products must be substantially similar to that in currently registered
technical products. Any manufacturing-use product not meeting these requirements
will be considered a new product and will require an amendment to the standard.
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2. Acute Toxicity Limits
The Agency will consider registration of technical grade and manufacturing-use
products containing barium metaborate for acute toxicity category II, provided
that the labeling of those products bears appropriate precautionary statements.
3. Use Patterns
To be registered under this standard, manufacturing-use products containing
barium metaborate may be labeled for formulation only into end-use products for
use as a modified barium raetaborate pigment that inhibits the growth of bacteria,
fungi, and other micro-organisms in paper coatings, paper board, and in paint.
The attached index entry lists currently registered uses for end-use products,
which have been formulated from the manufacturing-use products covered by this
standard.
G. REQUIRED LABELING
All technical grade and manufacturing-use products containing barium raetaborate
must bear appropriate labeling as specified in 40 CFR 162.10. Other portions
of this guidance package contain specific information regarding label requirements.
In addition, the following specific labeling requirement applies to technical
and manufacturing-use products.
Use Pattern Statement
"Barium metaborate may only be used for formulation into products intended for
the preservation of paint and other coatings, or to preserve coatings or sizing
for paper or paper board intended for contact with dry food products."
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III. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA Section 3(c)(2)(B)
and describes, in table format, the data required
for maintaining the registrability of each product.
Additionally, a bibliography (Appendix III-l) is
included that identifies that data considered as
part of the data base supporting this standard. EPA
has determined that additional generic data described
in this Notice must be submitted to EPA for evaluation
in order to maintain in effect the registration(s)
of your product(s) identified as an attachment to
the cover letter accompanying this guidance document.
As required by FIFRA Section 3(c)(2)(B), you are
required to take appropriate steps to comply with
this Notice.
EPA may suspend the registration of each of those products
unless, within the specified time, you have informed EPA
how you will satisfy the requirements of this Notice.
Any such suspension will remain in effect until you have
complied with the terms of this Notice.
B. What Generic Data VHust Be Submitted. You may ascertain
which generic data you must submit by consulting Table A
at the end of this section. That table shows all the
generic data needed to evaluate the continued registrability
of all products, 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 2/, or data collected under the approved
protocols of the Organization for Economic Cooperation
and Development (OECD). If you wish not to develop data
which are necessary to support the registration or
reregistration of certain uses appearing in your labeling,
you may delete those uses at the time you submit your
revised labeling.
Also for certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a "typical
formulation," and in those cases EPA needs data of that
1/ Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient (or all such
products having a certain use pattern), regardless of any such
product's unique composition or use. Product-specific data relate
only to the properties or effects of a product with a particular
composition (or a group of products with closely similar composition).
2/ The Pesticide Registration Guidelines were reproposed on
November 24, 1982 in 47 Federal Register 53192.
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type for each major formulation category (e.g., emulsifiable
concentrates, wettable powders, granulars, etc.) These
are classified as generic data and when needed are
specified in Table A. EPA may possess data on certain
"typical formulations" but not others. Note: The "typical
formulation" data should not be confused with product-
specific data (Table B) which are required on each
formulation. Product-specific data are further explained
in Section IV of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "FIFRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
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. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe
will satisfy the requirement, or state that
you will generate the data by conducting
testing. If the test procedures you will
use deviate from (or are not specified in)
the Registration Guidelines or protocols
contained in the Reports of Expert Groups
to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must enclose
the protocols you will use.
2. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly
develop (or share in the cost of developing) the
data. If you elect this option, you must notify EPA
which registrant(s) are parties to the agreement.
3. File with EPA a completed "Certification of Attempt to
Enter Into an Agreement With Other Registrants for
Development of Data" (EPA Form 8580-6, Appendix III-3)V"
4. Request that EPA amend your registration by deleting the
uses for which the data are needed. (This option is not
available to applicants for new products.)
FIFRA Section 3(c)(2)(B) authorizes joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's dec is ion if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
(Footnote continued at bottom of next page)
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5, Request voluntary cancellation of the registration(s)
of your products for which the data are needed. (This
option is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required
data or how quickly the data must be submitted. If the
test procedures you plan to use deviate from (or are not
specified in) the registration guidelines or protocols
contained in the reports of the Expert Groups to the
Chemical Groups, Organization for Economic Cooperation
and Development (OECD) Chemicals Testing Programme, you
must submit the protocol for Agency review prior to the
initiation of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product
Manager. The extension request should state the reasons
why you conclude that an extension is appropriate. While
EPA considers your request, you must strive to meet the
deadline for submitting the required data.
(Footnote continued from previous page)
In EPA's opinion, joint data development by all registrants
who are subject to the requirements to submit a pertinent item
of data or a cost-sharing agreement among all such registrants
is clearly in the public interest. Duplication of testing could
increase costs, tie up testing facilities, and subject an unneces-
sarily large number of animals to testing.
As noted earlier, EPA has discretion not to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). EPA has concluded that
it is appropriate to exercise its discretion not to suspend in
ways which will discourage duplicative testing. Accordingly, if
(1) a registrant has .informed us of his intent to develop and
submit data required by this Notice; and (2) a second regis-
trant informs EPA that it has made a bona fide offer to the
first registrant to share in the expenses of the testing [on
terms to be agreed upon or determined by arbitration under FIFRA
Section 3(c)(2)(B)(iii)]? and (3) the first registrant has declined
to agree to enter into a cost-sharing agreement, EPA will not
suspend the second firm's registration. While the first firm is
not required to agree to jointly develop data, EPA is not required
to force the second firm to engage in economically inefficient
duplicative testing in order to maintain its registration.
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TABLR A
GENERIC DATA REQUIREMENTS TOR BARIUM METABORATE
Data Kequirement
Composition
Does EPA Have Data
To Satisfy This
1/ Requirement? (Yes,
No or Partially)
?158.120 Product Chemistry
Product Identity:
61-2 Statement of Composition TGAI
61-3 Discussion of Formation of TGAI
Analysis and Certification of Product
Ingred ients
62-1 Preliminary Analysis TGAI
Physical and Chemical Characteristics
63-2 Color TGAI
63-3 Physical State TGAI
63-4 Odor TGAI
Partially
Partially
No
Yes
Yes
Yes
Bibliographic
Citation
GS-0024-009
05012282
GS-0024-009
GS-0024-009
GS-0024-009
Must Additional
Data Be Submitted
Under FIFRA Section
3(C)(2)(B)? 2/
Yes
Yes
Yes
No
No
No
1/ Composition - TGAI = technical grade of the active ingredient. PAI = pure active ingredient.
2/ Data roust be submitted no later than 6 months.
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TABLE A
GENERIC DATA REQUIREMENTS FOR BARIUM METABORATE
Does EPA Have Data Must Additional~
To Satisfy This Data Be Submitted
Use Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition 1/ Patterns 2/ No or Partially) Citation 3(c)(2)(B)? V
158.135 Toxicology
ACUTE
TESTING:
81-1
Oral LD50 ~ Rat
TGAI
H
Yes
GS-0024-006
No
81-2
Dermal LD5Q
TGAI
H
Yes
GS-0024-007
No
81-3
Inhalation LC50
TGAI
H
NO
Yes
81-4
Primary Eye Irritation
TGAI
H
Yes
GS-0024-008
No
SUBCHRONIC TESTING
82-2
21-Day Dermal
TGAI
H
No
No 4/
82-3
90-Day Dermal
TGAI
H
No
No 4/
82-4
90-Day Inhalation/
"IGAI
H
No
No 4/
Rat
1/ Composition - TGAI = technical grade of the active ingredient.
2/ The use patterns are coded as follows: A = terrestrial, food crop; B = terrestrial, non-food; C = aquatic, food crop;
D = aquatic, non-food,* E = greenhouse, food crop; F = greenhouse, non-food; G = forestry; H = domestic outdoor; I =
indoor.
3/ Data must be submitted no later than 6 months.
4/ Data are not required since use patterns associate with barium metaborate are not likely to result in significant
repeated human exposure.
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TABliE a
GENERIC DATA REQUIREMENTS FDR BARIUM METABORATE
Data Requirement
Does EPA Have Data
To Satisfy This
Use Requirement? (Yes,
Composition 1/ Patterns 2/ No or Partially)
Bibliographic
Citation
158.135 Toxicology
(continued)
CHRONIC TESTING
83-1 Chronic toxicity -
2 species: rodent
and non-rodent
MUTAGENICITY TESTING
84-2 Gene mutation
84-2 Chromosomal
aberration
84-2 Other mechanisms
of mutagenicity
1GAI
83-2 Oncogenicity study - TGAI
2 species: rat and
mouse preferred
83-3 Teratogenicity - TGAI
83-4 Reproduction - TGAI
2-generation
TGAI
TGAI
TGAI
H
H
H
H
H
H
H
No
No
No
NO
No
No
NO
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? 3/
No 4/
N° 4/
No 4/
No 4/
No 4/
NO 4/
No 4/
1/ Composition - TGAI = technical grade of the active ingredient.
2/ The use patterns are coded as follows: A = terrestrial, food crop; B = terrestrial, non-food; C = aquatic, food crop;
~ D = aquatic, non-food; E = greenhouse, food crop; F = greenhouse, non-food; G = forestry; H = domestic outdoor; I =
indoor.
3/ Data are not required since use patterns associated with barium metaborate are not likely to result in significant
repeated human exposure.
4/ Data are not required since use patterns associated with barium metaborate are not likely to result in significant
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IV. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: This section applies only to manufacturing-use products,
not end-use products.
A necessary first step in determining which statements must
appear on your product's label is the completion and submission
to EPA of product-specific data* listed on the form entitled
"Product Specific Data Report" (EPA Form 8580-4, Appendix IV-1)
to fill "gaps" identified by EPA concerning your product. Under
the authority of FIFRA Section 3(c)(2)(B), EPA has determined
that you must submit these data to EPA in order to register or
reregister your product(s). All of these data must be submitted
not later than six months after you receive this guidance document.
"Product-Specific Data Requirements for Manufacturing-Use
Products" appearing in Table B permit you to determine which
product-specific data you must submit. This can be done by
examining the entries in the column of those tables entitled
"Must Data Be Submitted Under §3(c)(2)(B)."
*j product specific data pertains to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicology data.
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table b
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING BARIUM METABORATE
Data Requirement
Composition^
1/
Dees EPA Have Data
Tto Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.120 Product Chemistry
Product Identity
61-1 Identity of Ingredients
61-2 Statement of Composition
61-3 Discussion of Formation
of Ingredients
MP
MP
MP
Partially
Partially
Partially
GS-0024-009
GS-0024-009
05012282
Yes
Yes
Yes
Analysis and Certification of Product
Ingredients
62-1 Preliminary Analysis MP
62-2 Certification of Limits MP
62-3 Analytical Methods for MP
Enforcement of Limits
No
No
No
Yes
Yes
Yes
Physical and Chemical Characteristics
63-2 Cblor MP
63-3 Physical State MP
63-4 Odor MP
63-12 pH MP
63-20 Corrosion characteristics MP
Yes
Yes
Yes
Yes
Yes
GS-0024-009
GS-0024-009
GS-0024-009
GS-0024-009
GS-0024-009
No
No
No
No
No
1/ Composition: MP = Manufacturing-use product,
~2/ Data must be submitted no later 6 months of receipt of this guidance package.
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING BARIUM MEFABORATE
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
1/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition No or Partially) Citation 3(c) (2) (B)?2/ ^
§158.135 Toxicology
ACUTE TESTING
81-1
Oral I.D50 - rat
MP
Yes
GS-0024-006
NO
81-2
Dermal LD^q
MP
Yes
GS-0024-007
No
81-3
Inhalation LC50
MP
No
Yes
81-4
Primary eye irritation
MP
Yes
GS-0024-008
No
81-6
Dermal Sensitization
MP
No
No 3/
1/ Composition: MP = Manufacturing-use product.
2/ Data must be submitted no later than 6 months.
3/ Data are not required since use patterns associated with barium metaborate are not likely to result in
significant repeated human exposure.
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V. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This section applies only to manufacturing-use products,
not end-use products.
The Agency requires applicants for registration or reregistra-
tion to ensure that each label (1) contains accurate, complete,
and sufficient instructions and precautions, reflecting the
results of data concerning the product and its ingredients, and
(2) incorporates labeling format and terminology which are suffi-
ciently standardized to avoid user confusion.
As part of your application, you will be required to submit
draft labeling consistent with: applicable product-specific
data; the precautionary statements and use directions; and the
regulations concerning classification [40 CFR §162.11(c)], pack-
aging 140 CFR §162.16], and labeling [40 CFR §162.10, Appendix
V-l and V-2], as indicated by the following paragraphs of this
section of the guidance document.
You will be informed later when you must submit the revised
labeling set forth in this guidance package.
A. Label Contents
40 CFR §162.10 (Appendix V-l) requires that certain spe-
cific labeling statements must appear at certain locations
on the label. This is referred to as format labeling.
Specific label items listed below are keyed to Tables D, E,
and F (Appendix Vl-2).
Item 1. PRODUCT NAME - The name, brand, or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading. See Appendix
V-l. [40 CFR §162.10(b)]
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
See Appendix V-l, [40 CFR §162.10(c)]
Item 3. NET CONTENTS - A net content statement is required
on all labels. The preferred location is the bottom of the
front panel immediately above the company name and address,
or at the end of the label text. The net contents must be
stated in terms of weight, expressed as avoirdupois pounds
16
-------
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 contents may be
expressed in metric units. See Appendix V-l. [40 CFR
§162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg, No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix v-l.
[40 CFR §162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment registration number on
the immediate container cannot be clearly read through such
wrapper or container. See Appendix V-l. [40 CFR §162.10(f)]
Item 6. INGREDIENT STATEMENT - An ingredient statement
is required on the front panel and must contain the name and
percentage by weight of each active ingredient and the total
percentage by weight of all inert ingredients. The preferred
location is immediately below the product name. The ingredient
statement must run parallel with, and be clearly distinguished
from, other text on the panel. It must not be placed in the
body of other text. See Appendix V-l. [40 CFR 162.10(g)]
Item 6A. POUNDS PER GALLON STATEMENT - For liquid
agricultural formulations, the pounds per gallon of active
ingredient must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - All labels
are required to have precautionary statements grouped together
on the front panel, pre ferably with in a block outline. The
table below shows the minimum type size requirements on
various size labels, as set forth in the Regulations.
17
-------
Size of Label
on Front Panel
in Square Inches
Signal Word as Re-
quired Minimum Type
Size All Capitals
Keep Out of Reach
of Children"
as Required
above 5 to 10
above 10 to 15
above 15 to 30
over 30
5 and under
6 point
10 point
12 point
14 point
18 point
6 point
6 point
8 point
10 point
12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - All labels are
required to have the statement "Keep Out of Reach of Children"
located on the front panel above the signal word except where
contact with children during distribution or use is unlikely.
See Appendix V-l. [40 CFR §162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (Caution, Warning,
or Danger) is required on the front panel immediately below
the child hazard warning statement. See Appendix V-l.
[40 CFR §162.10 (h) (1)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, inhala-
tion, or dermal toxicity, the word "Poison" shall appear on
the label in red on a background of distinctly contrasting
color and the skull and crossbones shall appear in immediate
proximity to the word poison. See Appendix V-l. [40 CFR
§162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix V-l. [40 CFR §162 .10(h ) (1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
See Appendix v-l. [40 CFR §162.10(h)(1)(iii)J
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix V-l. [40 CFR §162.10
(h)(2)]
18
-------
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions taken to avoid
accident, injury or damage. See Appendix V-l, [40 CFR §162.10
{h)(2}(x ) ]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix V-l. [40 CFR
§162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammability statement. Precautionary statements
relating to flammability of a product are required
to appear on the label if it meets the criteria in
Appendix V-3. The requirement is based on the results
of the flashpoint determinations and flame extension
tests required to be submitted for all products.
These statements are to be located in the side/back
panel precautionary statements section, preceded by
the heading "Physical/Chemical Hazards." Note that
no signal word is used in conjunction with the flam-
mability statements.
2. Criteria for declaration of non-flammability. The
following criteria will be used to determine if a
product is non-flammable:
a. A "non— flammable gas" is a gas (or mixture of
gases) that will not ignite when a lighted match
is placed against the open cylinder valve.
b. A "non-flammable liquid" is one having a flash-
point greater than 350°F (177°C) as determined
by the method specified in 40 CFR §163 . 61-8(c)(13)
(ii) of Subpart D.
c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches, using the
method specified in 40 CFR §163 . 61-8(c)(13)(ii)?
ii. There is no flash back; and
iii. The flashpoint of the non-volatile liquid
component is greater than 3500F (177°C),
determined by the method specified in 40 CFR
§163.61-8(c)(13)(i).
19
-------
3. Declaration of non-flamroability. Products which meet
the criteria for non-flammab.ility specified above may
bear the notation "non-flammable" or "nonflammable
(gas, liquid, etc.)" on the label.
It may appear as a substatement to the ingredients
statement, or on a back or side panel, but shall not
be highlighted or emphasized (as with an inordinately
large type size) in any way that may detract from
precaution.
4. Other physical/chemical hazard statements. When
chemistry data submitted in accordance with 40 CFR
§163.61-10(c) demonstrate hazards of a physical or
chemical nature other than flammabi1ity, 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. 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."
See Appendix V-l. [40 CFR §162.10(1)(2)(ii)]
Item 10a. STORAGE AND DISPOSAL BLOCK — All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. 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 for the latest specific
storage and disposal product label statements.
Item 10B. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix V-l. [40 CFR §162.10]
B. Collateral Information
Bulletins, leaflets, c .irculars, 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.
20
-------
V.
All applications prepared in response to this Notice should
be addressed as follows•
Henry M. Jacoby, Product Manager 21
Phone No. 703/557-1900
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
For each product for which continued registration is desired:
1. Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet" EPA
Form 8580-1. Refer to Appendix II-2 with appropriate
attachments.
2. Within 6 months from receipt of this document registrants
must submit:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product Specific Data Report, EPA Form 8580-4 (Appendix
III-l) .
c. Two copies of any required product-specific data.
3. Within the time set forth in Table A, all generic data
must be submitted by the affected registrant(s).
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.
You will be informed at a later date when you must submit your
Application for Amended Pesticide Registration (EPA Form 8570-1)
and the revised labeling set forth in this guidance package.
21
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Appendix II-l
Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
22
-------
Appendix II-l
{cont i nued)
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trai1ing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted,
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A? the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
23
-------
Appendix II-1 (continued}
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base
Supporting Registrations Under the Standard
MRID 005012282
Kelly, A.; Walker, R.B.R., inventors; (1922)
Process for the manufacture of borax and
boric acid. British patent specification
175,201. Feb. 16. 2p.
GS-0024-006
GS-0024-007
Buckman Laboratories, Inc., Memphis, Tenn.;
Study by Raltech Scientific Services, Inc.,
Madison, Wisconsin; (1978) Acute Oral LD50
Toxicity Study Using Sprague Dawley Albino Rats
Buckman Laboratories, Inc., Memphis, Tenn.;
Study by Raltech Scientific Services, Inc.,
Madison, Wisconsin; (1978) Acute Dermal
Toxicity Study Using Sprague Dawley Albino Rats
GS-0024-008
Buckman Laboratories, Inc., Memphis, Tenn.?
Study by Raltech Scientific Services, Madison,
Wisconsin; (1978) Acute Eye Irritation
Toxicity Study Using Sprague Dawley Albino Rats
GS-OO 24-009
Buckman Laboratories, Inc., Memphis, Tenn.;
(1974) Product Data Bulletin No. Al, Busan
11-M.
24
-------
Appendix III-2
OMB Approval No. 2000-0468 (Expires 12-31-83)
i
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
jEPA REGISTRATION NO.
i
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
~ t. I will submit data in a timely manner to satisfy the fallowing requirements. If the test procedures I will use deviate from (or are not
specified in! the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicds Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
C 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
LJ 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
D 4, ! request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
~ 5, I request voluntary cancellation of the registration of this product. {This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8550-1 (10-82)
25
-------
Appendix III-3
OMB Approval No. 2000-0468 {Expires: 12-31-83)
CERTIFICATION OF ATTEMPT TO ENTER i
INTO AN AGREEMENT WITH OTHER REGISTRANTS J
(To qualify, certify ALL four items) FOR DEVELOPMENT OF DATA J
1. 1 am duly authorized to represent the following ficm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE J
ACTIVE INGREDIENT |
NAME OF FIRM
EPA COMPANY NUMBER jj
1
1
(This firm or group of firms is referred to below as "my firm".) f
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 J
items or data: i
My firm has offered in writing to enter into such an agreement Capias of the offers are attached. That offer was irrevocable and included an offer to be |
bound by an arbitration decision under FIFRA Section 3(c)(2HS)(iii) if final agreement on all terms could not be reached otherwise. This offer was made |
to the following firm(s) on the following date(s): I
NAME OF FIRM
DATE OF OFFER 5
4
5
I
I
i
t
|
¦
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration^) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
EPA Form 8580-6 (10-821
SIGNATURE
26
DATE
-------
Appendix IV-1
PRODUCT SPECIFIC DATA REPORT
EPA Registration No. Guidance Document for
Date
Registration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
(For EPA Use Only)
Accession Numbers
Assigned
Citing MRID#
Submit-
ting
Data
(At-
tached )
SI58.20
PRODUCT
CHEMISTRY
61-1
Identity of
ingredients
61-2
Statement of
composition
61-3
Discussion of
formation of
ingredients
62-1
Preliminary
analysis
62-2
Certification of
limits
62-3
Analytical methods
for enforcement
limits
63-2
Color
63-3
Physical state
63-4
Odor
63-5
Melting point
63-6
Boiling point
63-7
Density, bulk-
density, or
specific gravity
63-8
Solubility
63-9
Vapor pressure
63-10
Dissociation
constant
63-11
Octanol/water
partition
coefficient
63-12
pH
27
-------
Appendix IV-i (continued)
Registration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
(For EPA Use Only)
Accession Numbers
Assigned
Citing MEED#
Submit-
ting
Data
(At-
tached )
63-13
Stability
63-14
Oxidizing/reducing
reaction
63-15
Flammability
63-16
Explodability
63-17
Storage stability
63-18
Viscosity
63-19
Miscibility
63-20
Corrosion
characteristics
63-21
Dielectric break-
down voltage
§158.135
TOXICOLOGY
81-1
Acute oral LD-50,
rat
81-2
Acute dermal
LD-50
81-3
Acute inhalation,
LC-50 rat
81-4
Primary eye
irritation, rabbit
81-5
Primary dermal
irritation
81-6
Dermal sensitiza-
tion
28
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APPENDIX IV-2
LABELING REQUIREMENTS OF TOE FIFRA, AS AMENDED
APPLICABILITY
PLACEMENT ON LABEL
ITEM
LABEL ELEMEOT
OF REQUIREMENT
REQUIRED
PREFERRED
COMMENTS
1
Product name
All products
Front panel
Center front
panel
2
Company name
and address
All products
None
Bottom front
panel or end
of label text
If registrant is not the producer, must
be qualified by "Packed for . .
"Distributed by. . etc.
3
Net contents
All products
None
Bottom front
panel or end
of label text
May be in metric units in addition to
U.S. units
4
EPA Est. No.
All products
None
Front panel
Must be in similar type size and run
parallel to other type.
5
EPA Reg. No.
All products
None
Front panel,
immediately
before or
following
Reg. No.
May appear on the container instead of
the label.
6A
Ingredients
statement
All products
Front panel
Immediately
following
product name
Text must run parallel with other text
on the panel.
6B
Pounds/gallon
statement
Liquid products
where dosage
given as lbs.
ai/unit area
Front panel
Directly below
the main
ingredients
statement
7
Front panel
precautionary
statements
All products
Front panel
All front panel precautionary statements
must be grouped together, preferably
blocked.
7A
Keep Out of Reach
of Children
(Child hazard
warning)
All products
Front panel
Above signal
word
Note type size requirements.
7B
Signal word
All products
Front panel
Immediately
below child
hazard
warning
Note type size requirements.
29
-------
APPENDIX IV-2 (continued)
ITEM
LABEL ELEMENT
APPLICABILITY
OF REQUIREMENT
PLACEMENT
REQUIRED
ON LABEL
PREFERRED
CCMMEOTS
7C
Skull & cross-
bones and word
POISON (in red)
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
Front panel
Both in close
proximity to
signal word
7D
Statement of
practical
treatment
All products
in Categories
I, II, and III
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
for all.
7E
Referral
statement
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
Front panel
8
Side/back panel
precautionary
statements
All products
None
Top or side
of back panel
preceding
directions
for use
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
8A
Hazards to
humans and
domestic
animals
All products
in Categories
I, II, and III
None
Same as above
Must be preceded by appropriate signal
word.
8B
Environmental
hazards
All products
None
Same as above
Environmental hazards include bee
caution where applicable.
30
-------
APPENDIX IV-2 (continued)
ITEM
LABEL ELEMENT
APPLICABILITY
OF REQUIREMENT
PLACEMENT ON LABEL
COMMENTS
REQUIRED
PREFERRED
8C
Physical or
chemical
hazards
All pressurized
products, others
with flash
points under
150°F
None
Same as above
9A
Restricted
block
All restricted
products
Top center
of front
panel
Preferably
blocked
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
9C
Misuse
statement
All products
Inroediately
following
statement of
classifica-
tion or
ahead of
directions
for use
10A
Re-entry
statement
All
choli nesterase
inhibitors
In the
directions
for use
Immediately
after misuse
statement
IOC
Storage and
disposal block
All products
In the
d irections
for use
Immediately
before
specific
directions
for use or
at the end of
directions
for use
Must be set apart and clearly distin-
guishable from from other directions
for use.
10D
U.S.
Directions
for use
All products
None
None
May be in metric as well as U.S. units
31
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Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
Required Label Statement
I. Pressurized Containers
A.
B,
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 13 0 ° F
may cause bursting.
C. ALL OTHER PRESSURIZED
CONTAINERS
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
B. Flashpoint above 20°F
and over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
32
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Appendix IV-5
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. Storage Instructions:
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
Size of label
front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
10 and under .
Above 10 to 15
Above 15 to 30
Over 30. . . .
.6 point
.8 point
10 point
12 point
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Appendix IV-5 (continued)
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
B. Pesticide Disposal Instruetions ;
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food,
or feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity roust bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance."
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Appendix IV-5 {continued)
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance."
Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
3. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original
container in several layers of newspaper and discard in
trash."
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products intended for domestic use must bear one
of the following container disposal statements:
Container Type Statement
Non-aerosol products
(bottles, cans, jars)
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Non-aerosol products
(bags)
Do not reuse bag. Discard bag in trash.
Aerosol products
Replace cap and discard containers in
trash. Do not incinerate or puncture.
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Appendix IV-5 (continued)
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type Statement
Metal
containers
(non-aerosol)
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Container Type Statement
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused 1, dispose of in the same manner.
Paper and
plastic bags
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording).
1-Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
2The labels for all other products must bear container
disposal instructions, based on container type, listed
on the first page of this Appendix,
36
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Appendix IV-5 (continued)
Pesticides that are hazardous wastes under 40 CFR 261.33(e) and (f)
when discarded.
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active IngregTents, (no inertsT:
Acrolein
Aid icarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dini trophenol
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl] phosphorod ith ioate
(disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,Q-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4p6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octarnethylpyrophosphoramide (OMPA , schradar.)
Parath ion
37
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Appendix IV-5 (continued)
"Acutely Hazardous" Commercial Pesticides {RCRA "E" List)
Active Ingiredients continued:
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,O-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
There are currently no inert ingredients for commercial pesticides
on the "Acutely Hazardous" List (RCRA "E" List).
38
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Appendix IV-5 (continued)
"Toxic" Commercial Pesticide Products (RCRA ^F" List)
Active Ingredients:
Acetone
Aerylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacocylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1, 3,4-metheno-2H-cyclobuta[c,d]-pentalen-2-one
(kepone, chlordecone)
1,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
5-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12®)
3 f5-Dichloro-N-(1,1-dimethyl-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (DDD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1.2-Dichloropropane
1.3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,41-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyc1opentadiene
Hexachloroethane
Hydrofluoric acid
39
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Appendix IV-5 (continued)
"Toxic" Commercial Pesticide Products ( RCRA__"_F" List)
Active Ingredients:
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Ni trobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethy1, methyl ester
Propylene dichloride
Pyr icline
Resorcinol
Safrole
Selenium disulfide
Silvex
1.2.4.5-Tetrachlorobenzene
1,1,2., 2-Tetrachloroe thane
Tetrachloroethylene
2.3.4.6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Freon
2,4,3-Trichlorophenol
2,4 ,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid
Xylene
11®)
(2,4,5-T)
-------
Appendix IV-5 (continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Inert Ingredients:
Acetone
Acetonitrile
Acetophenone
Acrylic acid
An iline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluoromethane {Freon 12®)
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Th iourea
Toluene
1.1.1-Trichloroethane
1.1.2-Trichloroethane
Trichlorofluoromethane (Freon 11®)
Vinyl chloride
Xylene
41
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
CERTIFIED MAIL
SUBJECT: Initiation of Reregistration Process for Pesticide
Products Containing Barium Metaborate as the Single
Active Ingredient
Dear Registrant:
In accordance with the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended, EPA's Office of
Pesticide Programs has begun the reregistration process for
pesticide products containing the subject ingredient. Signifi-
cant changes to the statute were made in 1972, 1975, and
1978? thus, current requirements may be substantially different
from those in effect at the time your product(s) were registered.
The first phase of reregistration requires that you (1) make
a commitment to the Agency regarding data development and
(2) subsequently submit revised product labeling and associated
information.
This mailing contains the Guidance Document for prepara-
tion of submissions, as well as a listing of your affected
product(s) (Attachment A), and a separate list of registrants
with products subject to this standard and which contain
this active ingredient (Attachment B). The latter list is
for the purpose of cooperative data development.
The Guidance Document sets out the Agency's evaluation
of all available data pertaining to the subject chemical and
its registered uses, and its rationale for the regulatory
actions being taken at this time. Additionally, the Guidance
Document contains instructions describing certain of the
42
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steps you must take to maintain registration for your product(s).
Products not brought into compliance with the Guidance Document
as supplemented by subsequent information from EPA about compliance
with certain data support requirements will be subject to suspension
and/or cancellation.
Specifically, the enclosed Guidance Document does the
following:
1. Introduces the purpose of this document.
2. Explains the Agency's policy regarding data submis-
sion and identifies, in table format, the data
that must be submitted to complete the Agency's
evaluation of each product. In addition, a
bibliography identifying the data which is considered
part of the data base supporting the registration
standard is included.
3. Sets out time-frames for submission of required
data.
4. Explains how to revise labeling for maufacturing use
products. (As the Guidance Document explains,
labeling is not required at this time.)
5. Provides submission instructions.
Because of the variety and complexity of the requirements,
and the short statutory time-frames available for certain
actions, it is essential that you understand the specific require-
ments and procedures in order that you may respond in a correct
and timely manner. Since a part of these requirements is under
Section 3(c)(2)(B) of FIFRA, your first response may be required
within 90 days from receipt of this letter. Please note that
if you do not respond or do not comply fully with the requirements,
your application may be rejected or your product registration
cancelled or suspended.
If, after reviewing this material, you do not understand
what you must do or how or when you must respond, please contact
the Product Manager listed below who will assist you in every
reasonable way. If you wish to discuss the data requirements
or request that certain data be waived, you must write to the
Agency and indicate those data requirements with which you take
issue and your rationale for doing so. After the Agency has
had a chance to review your submission, the Product Manager will
contact you to set up a meeting for the purpose of resolving all
issues relative to data requirements.
43
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Please note that this guidance document will eventually
be supplemented by EPA with additional information about
compliance with data support requirements. In Monsanto v.
Administrator, EPA was recently enjoined by the District
Court for the Eastern District of Missouri from implementing
in any way the "mandatory data licensing" aspects of §3(c>(1)(D)
of FIFRA. EPA is assessing the implications of the injunction
for the reregistration process. Because of this unresolved
situation, EPA has decided to proceed with the requirements in
this guidance package which do not relate to the "data licensing
issue and to supplement the package with additional guidance
when circumstances permit.
If you have any questions concerning this Guidance Document
you may contact the Product Manager listed below:
Mr. Henry M, Jacoby
Product Manager 21
Registration Division (TS-767}
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
Telephone (703) 557-1900
Sincerely,
Douglas D. Campt, Director
Registration Division (TS-767)
Enclosure
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