GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
POTASSIUM BROMIDE (KBr)
AS THE ACTIVE INGREDIENT
Case Number 342
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
-------
279S2
TABLE OF CONTENTS
Page
I. Introduction 1
II. Regulatory Position and Rationale 4
III. Requirement for Submission of Generic Data 18
IV. Requirement for Submission of Product-Specific
Data 27
4
V. Submission of Revised Labeling and Packaging <
Information 31
A. Label Contents 31
1. Product Name 31
2. Company Name and Address 31
3. Net Contents 31
4. Product Registration Number 32
5. Producing Establishment
Registration Number . . 32
6A Ingredient Statement .- . 32
6B Pounds Per Gallon Statement . . 32
7v Front Panel Precautionary Statements ...... 32
7A Child Hazard Warning Statements. . .' 33
7B Signal Word 53
7C Skull and Crossbones and Word Poison 33
7D Statement of Practical Treatment 33
7E Referral Statement 33
8. Side/Back Panel Precautionary Labeling 33
8A Hazard to Humans and Domestic Animals 3Zf
SB Environmental Hazard 3/t
8C Physical or Chemical Hazard 34
9 Misuse Statement 35
10A Storage and Disposal Block 35
10B Directions for Use 35
B. Collateral Information 35
VI. Instructions for Submission. . 36
-------
APPENDICES
III-l Bibliography.
III-2 FIFRA S3(c)(2)(B) Summary Sheet - EPA Form 8580-1 .
III-3 Certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data
EPA Form 8580-6
IV-1 Product Specific Data Report (End-Use Products)
EPA Form 8580-4 . . .
V-l Labeling Requirements, Section 162.10 of 40 CFR
V-2 Table of Labeling Requirements and Sample Labels. .
V-3 Physical/Chemical Hazards Labeling Statement. . . .
V-4 Storage and Disposal Instructions
Note: Appendices v-2, V-5 and V-6 are not germane to this
document and are not included.
-------
(1)
INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA Section 3(g)),as amended in 1978, directs EPA to
reregister all pesticides as expeditiously as possible.
Each registrant of a manufacturing use product of the active
ingredient who wishes to continue to sell or distribute that
product must apply for reregistration.
To fulfill this Congressional mandate, we have established
the Registration Standards program which will review all pesti-
cide active ingredients first registered before January 1,
1977. These pesticides will be reviewed in use clusters
which are prioritized on the basis of a ranking scheme giving
preference to pesticides used on food and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient. Our reassessment results in the development
of a regulatory position, contained in this document, on
each pesticide and its uses. The regulatory position may
require the registrant to modify product labels to provide
additional precautionary statements, restrict the use of the
pesticide to certified applicators, provide reentry intervals,
modify uses or formulation types, specify certain packaging
limitations, or other requirements to assure that proper use
of the pesticide poses no potential adverse effects to human
health or the environment.
The scientific review, which is not contained herein
but is available upon request, concentrates on the technical
grade of the active ingredient and identifies missing generic
data. However, during the review of these data we are also
looking for potential hazards that may be associated with
the formulated (end-use) products that contain the active
ingredient. If we find serious concerns, we will bring
formulated products under the provisions of the Registration
Standards program to the extent necessary to protect the
public.
EPA has the authority under FIFRA §3(c)(2)(B) to require
that certain registrants submit generic data that will answer
our questions regarding the hazard that may result from the
intended use of the pesticide under review. Further, §3(c)
(2)(B) provides that these data are to be submitted by
those registrants who do not qualify for the fc rmulator's
exemption [FIFRA §3(c)(2)(D)]. Normally, this means that
the registrants who are responsible for fillii.g the data
gaps are the manufacturina-use product producers (basic
-------
(2)
suppliers of the active ingredient). However, end-use producers
will not qualify for the formulator's exemption if the source of
their active ingredient: (1) is not registered with EPA, and/or
(2) is produced by the registrant's firm, or by a firm which has
ownership in common with the registrant's firm. These end-use
producers can qualify for the formulator's exemption if they change
their source of supply to a registered source, provided the source
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 sub-
mitted to the appropriate Product Manager within 90 days of re-
ceipt of this Guidance Document. The chart on the following page
shows what is generally required of those who do and do not qual-
ify for the formulator's exemption in the Registration Standards
program.
If you decide to request the Agency to discontinue the re-
gistration of any of your products subject to the reregistration
requirements of this ;Guidance Document, please notify the Prod-
uct Manager named in the cover letter, within 90 days from
receipt of this document, that you wish to voluntarily cancel the
registration(s). If you decide to maintain your product registra-
tion(s), you must provide the information described in the follow-
ing pages within the time frames outlined. EPA will issue a no-
tice of intent to cancel or suspend the registration of any cur-
rently registered product if you fail to comply with the require-
ments set forth in this Guidance Document.
This Guidance Document will be supplemented by EPA with ad-
ditional information about compliance with data support require-
ments. In Union Carbide Agricultural Products Co., Inc. v Ruckels
haus, EPA was enjoined from permitting or implementing any use of
data where the submitter's compensation is to be determined under
Section 3(c)(l)(D) of the 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
those requirements in this Guidance Document which do not relate to
compliance with the §3(c)(l)(D) provisions, and to supplement the
document with additional guidance when circumstances permit.
Failure to comply with the provisions of the subsequent guidance
will also result in issuance by EPA of an intent to cancel the
affected product registration(s).
Registrants are reminded that §6(a)(2) of FIFRA requires
you at any time to submit factual information raising concerns
of possible unreasonable adverse effects of a pesticide. You
should notify the Agency of interim results of studies in prog-
ress if those results show possible adverse effects.
-------
(3)
PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active Ingredient
Products*
These products must be reregis-
tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
B. Multiple Active Ingredient
Products
See Section C(l)(b)on page 7,
and Section C(3)(b) on page 8
of this standard,
II. Products That Do Qualify For
The Formulator's Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, including but not
limited to th-e Label Improvement
Program and special intent
to cancel notices.
* End-use products of registrants who also produce a manufacturing-
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing-use product(s). Such end-use products
will be subject to the labeling changes required for products in "II"
above. If there are no manufacturing-use products registered by any
company end-use products will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet the requirements in
I-A and B above, then the registrants in "II" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in I-A and B. .
-------
(4)
II REGULATORY POSITION AND RATIONALE
A- INTRODUCTION
Registration standards describe the regulatory position
and rationale for all registered manufacturing-use prod-
ucts (MUPs) containing the chemical under review as the
sole active ingredient. End-use products (EUPs) are
reviewed only when there are no MUPs registered or when
a label is changed significantly. There are no regis-
tered MUPs containing Potassium Bromide as the sole act-
ive ingredient. Furthermore, there is only one regis-
tered end-use product (EUP) containing this chemical, and
it contains two other active ingredients. Therefore this
standard describes the regulatory position and rationale
for the unregistered technical grade of Potassium Bromide
(in the event a prospective registrant wishes to regis-
ter it as an MUP), and for the only registered use appear-
ing on the approved label of the registered product con-
taining this chemical.
1. Manufacturing-Use Products (MUPs)
Potassium Bromide is not registered as a manufact-
uring-use product (MUP). The technical grade of the
active ingredient is available as an unregistered
material from chemical supply houses, at about 99%
purity. The non-pesticidal uses for this chemical
outnumber and outweigh in economic importance the
pesticidal use. Therefore this standard is a modifi-
cation of the usual standard: it applies to the ap-
proved uses of the only registered product contain-
ing this chemical, an end-use product containing
multiple active ingredients.
2. End-Use Products (EUPs)
The registered product containing Potassium Bromide
as an active ingredient is an end-use Product (EUP):
SAF-SOL Brand For Istitutional Use
EPA Registration No. 875-42
Diversey Wyandotte
1532 Biddle Ave
Wyandotte, MI 48192
-------
(5)
The approved label for the registered product lists
three active ingredients:
Sodium Hypochlorite 3.25%
Potassium Bromide 2.00%
Sodium Phosphate 89.75%
The product was registered on August 15, 1960, without any
supporting acute toxicity data. The approved label bears
the signal word WARNING, which places it in toxicity cate-
gory II, most probably because the rpoduct contains 89.75%
Sodium Phosphate, a chemical which may be irritating to
eyes at this concentration.
B• DESCRIPTION OF THE CHEMICAL
Potassium Bromide is an old, well known inorganic
chemical whose chemical and toxicological properties are
extensively documented in the published literature. The
Merck Index, 4th Edition, provides the following informa-
tion for this chemical: KBr, molecular weight 119.01,
Br 47.85%. K 23.41%, O 28.74%, colorless crystals or
white granules, or powder; density 2.75, melting point
730°C; 1 gram dissolves in 1.5 ml water or in 250 ml
alcohol. The aqueous solution is neutral. Human Toxi-
city: large doses cause central nervous system depression;
prolonged intake may cause mental deterioration, acneform
skin eruptions. Uses; sedative, anti-convulsant.
The Chemical Abstracts Service (CAS) Registry number is
7758-02-3: the EPA Chemical Code Number is 041101.
-------
(6)
C. REGULATORY_POSITION AND RATIONALE
After reviewing and evaluating the available data and
other relevant information on Potassium Bromide, the
Agency has made the following determinations with res-
pect to the technical grade of the active ingredient
(TGAI) _!/', and the end-use registered product.
1. Acute Toxicity
(a) Manufacturing-Use Products
The technical grade of Potassium Bromide has not
been registered as a manufacturing-use product,
even though the chemical appears as an active in-
gredient on labeling accepted for an end-use prod-
uct. Therefore no one has submitted acute toxicity
data for the TGAI to support registration as an MUP.
Nevertheless, the Agency will not require generation
of acute toxicity data to register the TGAI as an MUP
unless the applicant or registrant fails to cite or
submit relevant information from the published lit-
erature to establish the toxicity categories of the
TGAI in accordance with Section 162.10 of Title 40 of
the Code of Federal Regulations.
Rationale: In accordance with Pesticide Registration
Notice 83-4 2/ and 83-4(A) 3/ a registrant has the
option of satisfying a data requirement to register
a pesticide by submitting or citing relevant data from
the published literature instead of generating such data
In the case of the technical grade of Potassium Bromide
a registrant should have no difficulty in submitting or
citing information from the pubished literature on this
chemical to satisfy at least some, if not all, of the
acute toxicity data requirements, listed in Table A at
the end of this chapter.
I/ For the purpose of this standard the technical grade of
Potassium Bromide is defined as any material containing 99%
KBr, and containing only those impurities generally associated
with the manufacturing process, and generally .considered as safe.
2/ Pesticide Registration Notice 83-4, June 16, 1984. Interim
Procedures For Satisfying Registration Data Requirements Under
Recent Court Actions.
3/ Pesticide Registration Notice 83-4(A), June 23, 1984. Supple-
ment to PR Notce 83-4.
-------
(7)
(b) End-Use Products
To reregister the end-use product cited in this
standard the registrant must not only satisfy the
product specific data requirements specified in
Table B, but he or she must also satisfy the generic
items of cata pertaining to the technical grade of
Potassium Bromide specified in Table A, at the end of
this chapter. These include acute toxicity data and
fish and wildlife data.
Rationale: The registrant of the end-use product
cited in this standard uses an unregistered source
of the technical grade of the active ingredient.
This prevents the registrant from qualifying under
the formulator's exemption as explained on page 1
of this standard, and in PR Notice 83-4 previously
cited.
2. Chronic Toxicity
The Agency has concluded that none of the criteria
for unreasonable adverse effects listed in Section
162.11 (a) of 40 CFR have been triggered or exceeded
for the uses specified in this standard.
Rationale: A review of relevant information in the
published literature I/ on Potassium Bromide has raised
no chronic or long term toxicological concerns for the
approved pesticidal use. Furthermore, the registered use
is as a final sanitizing rinse on food contact surfaces.
Potassium Bromide, in combination with other chemicals
generally recognized as safe, is cleared for this use
as an incidental food additive under Section 178.1010
(b)(l) of Title 21 of the Code of Federal Regulations,
which is administered by the Food and Drug Administra-
tion. Each end-use product proposed for this use must
comply with the provisions of this section.
I/ Appendix III-l, GS-0342-003, Spencer, H. G. et al, Food
Research, 9:11, 1944.
-------
(8)
3. Ecological Effects
(a) Manufacturing-Use Products
To register the technical grade of Potassium Brom-
ide as a manufacturing-use product a registrant must
satisfy the data requirements specified in Table A
at the end of this chapter.
Rationale: According to the guidelines I/ the Agency
requires toxicity data on fish, birds, and aquatic
invertebrates to support the registration of all
mamufacturing-use products.
(b) End-Use Products
(i) Registrants of end-use products who qualify un-
der the formulator's exemption may register end-
use products for the use specified in this
standard without having to address or satisfy
the data cited above.
Rationale: According to the guidelines, ecolo-
gical effects data must be developed by testing
the technical grade of the active ingredient or
the manufacturing-use product. In order to be
exempt from these data requirements and qualify
under the formulator's exemption, the registrant
of the end-use product must purchase a register-
ed manufacturing-use product from another firm
for formulation into the end-use product.
(ii) Registrants who do not qualify under the formu-
lator's exemption must satisfy the data require-
ments specified in Table A by submitting data
developed with the technical grade of Potassium
Bromide.
Rationale: According to the guidelines, ecolo-
gical effects data must be developed by testing
the technical grade of the active ingredient or
the manufacturing-use product. The registered use
cited in this standard is an indoor use? it does
not pose an additional risk to non-target organ-
isms which is not already introduced by the tech-
nical grade of Potassium Bromide. Only when the
use of an end-use product introduces an addition-
al risk to non-target organisms, which has not
been addressed by data developed with the MUP,
is additional data required of an end-use product.
T7~GuideTines for Pesticide Assessment, Subdivision E, Hazard Eval-
uation, Wildlife and Aquatic Organislms, EPA Document 540/9-82-024,
October 1982, available from the National Technical Information
Service, Springfield, VA, Order No. PB83-1531908.
-------
(9)
In the case of the registered product cited
in this standard, the registrant uses an
unregistered source of the technical grade of
Potassium Bromide. Therefore, to reregister
this product, the registrant roust satisfy the
data requirements specified in Table A, as well
as those in Table B. For further clarification
of this obligation, see pages 1 and 2, Section C(l)(b)
on page 7 of this standard, and PR Notice 83-4
previously cited.
4. Environmental Fate Chemistry
No environmental fate chemistry data will be required
to re-register the currently registered use. However,if
a use such as terrestrial, aquatic, or forest use is pro-
posed for registration, environmental fate chemistry
data will be required in accordance with the guide-
lines I/.
Rationale: The currently registered use is an indoor use:
to sanitize food handling equipment and utensils in food
processing establishments. The registered product is
used as a very dilute aqueous solution which goes to
sewage treatment plants through the municipal sewer sys-
tems. Here the chemical is degraded with other compo-
nents during the treatment process, going from there
back to receiving natural bodies of water. Given this,
and the registered use being an indoor use, environment-
al fate chemistry data are not required.
!_/ Guidelines for Pesticide Assessment, Subdivision N, Environ-
mental Fate, EPA Document No. 540/9-82-021, Octobrer 1982, a-
vailable from the National Technical Information Service, Spring-
field, VA, Order No. PB83-1539/3.
-------
(10)
5• Residue Chemistry
No residue chemistry data will be required to re-
register the currently registered use.
Rationale: Residue chemistry data are required to
support a petition for a tolerance or an exemption
from the requirement of a tolerance when a pesticide
use may result in residues in food, feed, tobacco,
or other articles used for food or drink for man or
animals. For more details on the residue chemistry
data requirements the guidelines should be consulted.!/
The registered use for Potassium Bromide is not for
direct application on a food crop or food as defined
in the guidelines. However, the registered use for
the end-use product is as a final sanitizing rinse
on food contact surfaces, and food handling equipment
and utensils in food processing establishments. As
such it is considered an incidental or indirect food
additive. Therefore all end-use products proposed for
this use must be cleared under the provisions of
Section 178.1010 (b) (1) of Title 21 of the Code of
Federal Regulations which is administered by the
Food and Drug Administration, in accordance with
that Agency's requirements.
The registered product cited in this standard has been
cleared under Section 178.1010 (b) (1) of 21 CFR, for
the registered use.
6. Federal or State Re-entry Levels
It is not necessary to establish federal or state re-
entry levels for Potassium Bromide.
Rationale: The registered use is an indoor use with no
application to food crops or fields involving exposure
to farm workers or field workers.
7. Ground Water Contamination
No data will be required pertaining to ground water
contamination.
_!/ Guidelines for Pesticide Assessment, Subdivision O, Residue
Chemistry, EPA Document No. 540/9-82-023, October 1982, avail-
able from the National Technical Information Service, Spring-
field, VA, Order No. PB83-153981.
-------
(11)
Rationale:
The registered use for the registered product is an
indoor use: to sanitize food handling equipment and
utensils in food processing establishments. As such,
the concentration of Potassium Bromide in the use
dilution is very small. Potassium Bromide and other
chemicals go through municipal sewers, eventually to
sewage treatment plants, where these chemicals are
further diluted and broken down in the various stages
of sewage treatment before finally going back into
receiving natural bodies of water. Hence, there is no
concern over ground water contamination.
8. Registration of Manufacturing-Use Products
Manufacturing-Use Products containing Potassium Bromide
as a sole active ingredient may be registered for sale,
distribution, reformulation, and use, subject to the
terms and conditions specified in this standard. Re-
gistrants must submit or agree to develop additional
data, as specified in the tables, in order to maintain
existing registrations or to permit new registrations.
Rationale: Under FIFRA, the Agency can not cancel or
withhold registration simply because data are missing
or inadequate (See Sections 3(c)(2)(B) and 3(c)(7) of
the FIFRA). Rather, issuance of this standard provides
a mechanism for identifying data needs. The data will
be reviewed and evaluated when they are received and
the Agency will determine at that time if they will
affect the registration of Potassium Bromide.
9• Registration of End-Use Products
In accordance with PR Notice 83-4, the registrant for the
end-use product cited in this standard is responsible for
satisfying the data requirements for the technical grade
of Potassium Bromide (Table A), as well as those of the
end-use product (Table B). (See also page 1, §C(l)(b) page 7,
and §C(3)(b) page 8 of this standard.)
Rationale: As stated in previous sections of this
document, the end-use product cited in this standard must
be reregistered in accordance with this standard because
the technical grade of Potassium Bromide is not registered
as a manufacturing-use product. Furthermore, since the
active ingredient present in the end-use product comes from
an unregistered source, the registrant of the end-use
product does not qualify under the formu\ator's exemption.
-------
(12)
D. CRITERIA FOR REGISTRATION UNDER THIS STANDARD
To be covered by this standard, products must contain
Potassium Bromide as an active ingredient, bear required
labeling, and conform to the product composition, acute
toxicity limits, and use pattern requirements listed in
Section E (3) of this chapter.
The applicant for registration or reregistration of
products subject to this standard must comply with all
terms and conditions described in it, including sub-
mission of an up-to-date Confidential Statement of
Formula, submission of revised labeling, and commitment
to fill data gaps on the schedule specified by the Agency.
When circumstances permit, the standard will be sup-
plemented with additional guidance as to data compensa-
tion under Sections 3(c)(l)(D) and 3(c)(2)(D) of the
Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended, 7 U.S.C. 136(c)(l)(D) and 136(c)(2)(D).
Registrants should contact the Agency for specific in-
structions, including updated information on data re-
quirements .
E. ACCEPTABLE RANGES AND LIMITS
1. Product Composition
(a) Manufacturing-Use Products
The technical grade of Potassium Bromide has
been defined in this standard as material con-
taining 99% KBr, with only those impurities which
are usually considered part of the manufacturing
process. If a product of lower purity is pro-
posed as a manufacturing-use product (MUP), the
standard must be amended to accommodate such a
product. In any case, a manufacturing-use prod-
uct may contain only those inert ingredients
which are either part of the manufacturing prod-
cess, or are deliberately added to give the prod-
uct stability or to serve some such other useful
purpose, provided however, that all inert ingred-
ients are generally recognized as safe. Each MUP
proposed for registration must be fully described
with an appropriate certification of limits.
-------
(13)
(b) End-Use Products
End-use products proposed for registration under
this standard must be substantially similar to the
product described on page 4 of this chapter. A
product will be considered substantially similar
to the registered product if it contains the-.same
active ingredients at approximately the same con-
centrations, and if it contains inert ingredients
generally considered as safe. Furthermore the use
proposed for the product must be for the same use
as that of the registered product cited in this
standard, i.e. as a final sanitizing rinse on food
contact surfaces, equipment, and utensils in food
processing establishments.
2 . Acu_te_ Toxicity _Limits
(a) Manufacturing-Use Products
The Agency will consider registration of technical
grade products and manufacturing-use products con-
taining Potassium Bromide for any proposed acute
toxicity categories, provided that the registrant
submits enough relevant information, either from
the published literature or from other sources, to
establish the various acute toxicity categories for
the various routes of exposure, thereby permitting
the Agency to prescribe appropriate precautionary
statements, consistent with Section 162.10 of 40 CFR.
(b) End-Use Products
The only product containing this chemical was re-
gistered before 1975, without any supporting acute
toxicity data, because at that time the Agency did
not routinely require acute toxicity data for all
pesticides. To reregister this product or to re-
gister similar products the registrant must submit
acute toxicity data I/ (oral LDso, dermal 1*050'
and eye irritation data) specific to the particular
end-use product. This is required to establish the
acute toxicity categories for these potential routes
of exposure, and thus enable the Agency to prescribe
appropriate precautionary statements in accordance
with Section 162.10 of 40 CPR. See Table B at the
end of this chapter.
I/ Guidelines for Pesticides Assessment, Subdivision F. Hazard
Evaluation to Humans and Domestic Animals, Document No.
540/9-82-025, October, 1982, available from the National Technical
Information Service, Springfiled, VA, Order No. PB83-1.>36.
-------
(14)
.Use. JPatterns
To be registered under this standard, manufacturing-
use products containing Potassium Bromide may be la-
beled for formulation into end-use products only for
the following use: as a final sanitizing rinse on food
contact surfaces, food handling equipment, and uten-
sils in food processing establishments. All end-use
products containing this use must comply with the
provisions of Section 178.1010 of Title 21 of the Code
of Federal Regulations, which is administered by the
Food and Drug Administration.
Furthermore, this is the only use which has been ap-
proved for the registered end-use product. To regis-
ter this chemical for additional uses a registrant must
submit an application to amend this standard, and
address whatever additional data requirements such
uses would incur.
F. REQUIRED LABELING
All manufacturing -use products and end-use products must
bear appropriate labeling as specified by Section 162.10
of 40 CFR. For more details on these general labeling
requirements see Chapter V of this standard. The follow-
ing specific comments apply to the labeling for pesti-
cides containing Potassium Bromide.
1. Ingredient Statement
The ingredient statement for Manufacturing-Use Prod-
ucts and End-Use Products must appear on the front
part of the label as:
Potassium Bromide %
2. Use Patterns
The label for all manufacturing use products must
state that they are intended for formulation
into end-use products only for the aforementioned .
use patterns. Labeling must specify sites, which
are listed in Section E(3) of this chapter. A li-..
miting factor will be data that support these use
patterns. No use may be included on the label where
the registrant fails to agree to comply with the
data requirements in either Table A or Table B of
this standard for that use pattern. Besides this,
the label for an MUP must state that each formu-
lator must satisfy EPA's requirements to register
each formulated product.
-------
(15)
Precaut^onar^ Statements
(a) Manufacturing-Use Products
(i) Labels for all manufacturing-use products
containing Potassium Bromide must bear state-
ments reflecting the product's acute human
toxicity as explained previously at Section
E(2)(a) of this chapter.
(ii) The following environmental hazard statement
must appear on the label of all MUPs, under
the required heading as designated below:
ENVIRONMENTAL HAZARDS: Do not discharge ef-
fluent containing this active ingredient in-
to lakes, streams, ponds, estuaries, oceans,
or public waters unless this product is speci-
fically identified and addressed in an NPDES I/
permit. Do not discharge effluent containing
this product to sewer systems without previous-
ly notifying the sewage treatment plant author-
ity. For guidance contact your State Water
Board or Regional Office of the EPA.
(iii) Depending on the results of the environmental
effects data required to register the MUP the
label may require a fish and/or wildlife hazard
statement, as specified in Section 162.10(h)(2)(ii)
of 40 CFR. For the data requirements see Table
A at the end of this chapter.
(b) End-Use Products
The requirement for the environmental hazard statement
listed in (a)(ii) above also applies to the label for the
end-use product cited in this standard because the use
is an industrial use, i.e. as a final sanitizing rinse
for food handling equipment and utensils in food
processing establishments.
I/ National Pollution Discharge Elimination System
-------
(16)
Labeling for each end-use product must bear
appropriate precautionary statements specific
for the product as formulated. These state-
ments must reflect the acute toxicity cate-
gories established by data relevant to the
particular product in question, in accordance
with Section 162.10 of 40 CFR. For the data
requirements see Table B at the end of this
chapter.
G. TOLERANCE REASSESSMENT
The registered use for Potassium Bromide does not in-
volve direct application to a food crop or to feed.
If a registrant proposes to register the chemical for
direct application to a food crop, tobacco, or feed,
or to other articles used for food or drink for man or
animals, residue chemistry data will be required to
support a petition for a tolerance, or an exemption
from the requirement of a tolerance.
The registered use is as a final sanitizing rinse for
food contact surfaces, food handling equipment and
utensils in food processing establishments. As such
this use is considered an incidental food additive.
Products proposed for this use must be cleared
under Section 178.1010 of 21 CFR, which is administered
by the Food and Drug Administration. This use has been
addressed at Section C(5) of this standard.
H. EFFICACY DATA REQUIREMENTS
Section 162.18-2(d)(2) of 40 CFR requires that "efficacy
data specific to each product that bears a claim to con-
trol organisms that may pose a threat to human health,
either directly or through transmittal of disease" must
be submitted to support the registration of such a prod-
uct. Each antimicrobial product intended to control
microorganisms infectious to man in any area where these
microorganisms may present a health hazard falls under
the requirement of this section. Microbiological efficacy
data are product specific; data for one product can not be
used to support registration of another product unless the
two products are identical. Even then confirmatory data
is required to register a product relying on data developed
with another product.
-------
(17)
The specific data requirements for end-use products in-
tended to provide health related benefits can be found
in the guidelines for product performance JL/. Besides
satisfying these requirements each end-use product pro-
posed for use as a final sanitizing rinse on food contact
surfaces, food handling equipment, and eating utensils
in food processing establishments, must comply with FDA's
regulations at Section 178.1010 of 21 CFR.
In the case of the only registered product referred to in
this standard, the efficacy data requirements have been
satisfied.
I/ Pesticide Assessment Guidelines, Subdivision G, Product
Performance, EPA Document No. 540/9-82-026, November 1982,
available from the National Technical Information Service,
Springfield, VA, Order No. PB83-153924.
-------
(18)
HI. 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 (Appendixm-1) 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 i
of your product(s) identified as an
the cover letter accompanying this
As required by FIFRA Section 3(c)(2i
egistration(s)
attachment to
uidance document.
(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 I/ Must Be Submitted. You may ascertaij
which generic data you must submit by consulting Table A
at the end of this chapter. That table shows all the
generic data needed to evaluate the continued registrabili
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
I/ 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 corapositij
2/ The Pesticide Registration Guidelines were reproposed on
November 24, 1982 in 47 Federal Register 53192.
-------
(19)
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 Chapter 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
J1I-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, AppendixZEI-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.)
V FIF1XA 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 decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
(Footnote continued at bottom of nexc. page)
-------
(20)
"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)J; and (3) the first registrant has declined
to agree to enter into a cost-sharing agreement, EPA will not
suspend the second firm's registration. 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.
-------
± n (T*
GENERIC DATA REQUIREMENTS FOR POTASSIUM BROMIDE (99% purity or higher)
Composition
(Unregistered
Data Requirement Product) I/
S158.120 Product Chemistry
Product Identity:
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation of
Ingredients
Analysip and certification of Product
Ingredient's
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods for
Enforcement of Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Sectio
No or Partially) Citation 3(c) ( 2) ( B) ?2/ 2/
Totally
partially
N/A
N/A
N/A
N/A
Totally
Totally
Totally
Totally
Totally
Totally
GS 0342-001
GS 0342-002
MRID 00019750
MRID 00007445
GS 0342-002
Standard Ref's
-
-
-
Standard Ref's
Standard Ref's
Standard Ref's
Standard T.rsf's
Standard Ref's
Standard Ref's
No
Yes
-
-
—
No
No
No
No £
No
No
Specific Gravity
-------
TABi
GENERIC DATA REQUIREMENTS FOR POTASSIUM BROMIDE (99% purity or higher)
Data Requirement
Composition
(Unregistered
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
Bibliographic
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/ 2/
SI 58. 120 Product Chemistry
(continued)
63- 8 - Solubility XGAI
63-12 - pH . TGAI
63-13 - Stability XGAI
Totally Standard Ref's No
Totally Standard Ref's No
Totally Standard Ref's No
I/ Composition: TGAI - Technical grade of the active ingredient; PAI
several test substances determined on a case-by-case basis.
2/ Data must be submitted no later than
Pure active ingredient; Choice = Choice of
K>
to
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR POTASSIUM BROMIDE (99% purity or higher)
I/ Use 2/
Data Requirement Composition Patterns
S158.135 Toxicology
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
ACUTE TESTING:
81-1
81-2
81-3
81-7
- Oral LD5Q - Rat
- Dermal LD$Q - Rabbit
- Inhalation LC$Q - Rat
- Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
I
I
I
I
No
No
No
No
Yes 4/
Yes 4/
Yes 4/
Yes 4/
SUBCHRONIC TESTING:
82-1
82-2
82-3
82-4
- 90-Day Feeding -
Rodent, Non-rodent
- 21-Day Dermal - Rabbit
- 90-Day Dermal - Rabbit
- 90-Day Inhalation -
TGAI
TGAI
TGAI
TGAI
I
I
I
I
N/A
N/A
N/A
N/A
_
-
-
-
Rat
82-5 - 90-Day Neurotoxicity-
Hen/Mammal
TGAI
N/A
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR POTASSIUM BROMIDE (99% purity or higher)
S158.135 Toxicolog
(continue
I/ Composition: PAI * Pure active ingredient; PAIRA = Pure active ingredient, radiolabelled; Choice = Choice of several
test substances determined on a case-by-case basis.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aqautic, 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 .
4/ These data apply to the Technical Grade of potassium Bromide (99% purity or higher) . To date it has not been
registered as a Manufacturing Use Product for formulation into pesticides. If a registrant proposes to reg-
ister this product as an MUP pesticide, it is very likely that information addressing these requirements may be
obtained from the published literature, otherwise the registrant would have to develop these data to establish
the various acute toxicity categories for the TGAI or other MUP products, so that appropriate precautionary
labeling can be prescribed in accordance with Section 162.10 of 40 CFR.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR POTASSIUM BROMIDE (99% purity or higher)
Must Additional
Data Be Submitted
Under FIFRA Section
3
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR POTASSIUM BROMIDE (99% purity or higher)
S158.145 Wildlife and Aquatic Organisms
(continued)
I/ Composition: TGAI « Technical grade of the active ingredient; PAI = pure active ingredient;
TEP » Typical end-use product; . ,
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food Crop; C-Aquatlc, tooo 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 _ ^ _ «
I/ These tests must be developed with the Technical Grade of potassium Bromide (99% purity or higher) to support
registration as a Manufacturing Use pesticide for the indoor uses specified in this standard. If the uses are
expanded to include other than indoor uses more data will be required.
-------
(27)
REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: This chapter 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 l¥-l)
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)."
*/ Product specific data pertains to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicology data.
-------
PRODUCT SPECIFIC DATA REQUIREMENTS FOR
TABLE B
END USE PRODUCT SAP SOL:
EPA REG NO: 875-42 3/
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
Data Requirement
Composition"
Does EPA Have Data
To Satisfy This
I/ 4/ Requirement? (Yes,
No or Partially)
Bibliographic
Citation
S158.120 Product Chemistry
Product Identity
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation
of Ingredients
Analysis and Certification
of Product Ingredients!
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods for
Enforcement of Limits
Physical and Chemical
Character istics"
63-2 - Color
63-3 - Physical state
63-4 - Odor
63-7 - Density, bulk density, or
specific gravity
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
Totally
Partially
Partially
N/A
partially
Totally
Totally
Totally
Totally
Totally
EPA Reg No 875-42
EPA Reg No 875-42
EPA Reg No 875-42
EPA Reg No 875-42
Standard Ref's
Standard Ref's
EPA Reg No 875-42
Standard Ref's
EPA Reg No 875-42
No
Yes
Yes
Yes
No
No
No
No
No
M
00
-------
Data Requirement
Composition"
Does EPA Have Data
To Satisfy This
I/ 4/ Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/6/
S158.120 Product Chemistry
(continued)
63-12 - pH
63-14 - Oxidizing or reducing
action
63-16 - Explodability
63-17 - Storage Stability
63-20 - Corrosion Characteristics
EP
EP
EP
EP
EP
Totally
Totally
Partially 4/
Totally
Totally
00007442
EPA Reg No 875-42
EPA Reg No 875-42
00007442
00007442
No
No
Yes
No
No
!_/ Composition:MP =Manufacturing-use product;Choice =Choice ofseveraltest substances determined on acase-by-'
~~ case basis.
2/ Data must be submitted no later than .
_3/ In view of its commercial availability as an engraving and photographic processing chemical, there is no
requirement under the FIFRA (or need) to register technical potassium bromide for manufacturing use.
4/ The active ingredients of SAP SOL* Brand Sanitizer are 2.00% potassium bromide, 3.25% sodium hypochlorite
and 89.75% trisodium phosphate (as a hydrate salt). Since anhydrous hypochlorite may be explosive, information
is needed concerning the hydrated form of sodium hypochlorite used in formulating SAP SOL* Brand Sanitizer.
j>/ For the technical potassium bromide used in formulating SAP SOL*, the Diversey Corporation is required to
submit the detailed composition data available from their supplier(s). This composition data should include the
amounts of lead and other heavy metal impurities. For the marketed product, information is needed concerning
the quality control procedures and a discussion of impurities that are expected to form during the commercial
life of the product.
6/ These chemistry data requirements apply for the reregistration of SAP SOL* (EPA Reg No 875-42) under this
Standard. They will not support registration of another end use product unless the product in question is
identical and then only with the permission from the owner to cite it. A registrant of any other end use
product containing potassium bromide would be required to address all of the applicable product chemistry
requirements specified in section 158.120 of 40 CFR. K?
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING POTASSIUM BROMIDE
Data Requirement
Composition'
I/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
S158.135 Toxicology
ACUTE TESTING
81-1 - Oral LDso - Rat
81-2 - Dermal LDso ~ Rabbit
81-3 - Inhalation LC$Q - Rat
81-4 - Primary Eye
Irritation - Rabbit
81-5 - Primary Dermal
Irritation - Rabbit
81-6 - Dermal Sensitization -
Guinea Pig
MP
MP
MP
MP
MP
MP
No
No
N/A
No
No
NO
Yes
Yes
Yes
Yes
No
I/ Composition: MP = Manufacturing-use product.
2/ data must be submitted no later than
-------
(31)
V. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This section applies to manufacturing-use products,
and 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 Sl62.11(c)], pack-
aging [40 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 VI-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.lO(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 5162.10(c)]
i
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 term?, of weight, expressed as avoirdupois pounds
-------
(32)
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
Sl62.10(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 similarito other print on that part of the
label on which it appears and must run parallel to it. The
registration number an
-------
(33)
Size of Label Signal Word as Re- "Keep Out of Reach
on Front Panel quired Minimum Type of Children"
in Square Inches Size All Capitals as Required
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
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-1. [40 CFR §l62.10(h) (1) (ii) 1
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-1.
[40 CFR §162.10 (h)(l)(i)l
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 rett on a background of distinctly contrasting
color and the skull and crossbones shall appear in immediate
proximity to the word poison. See Appendix V-1. [40 CFR
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-1. [40 CFR Sl62.10(h)(l) (ill)] .
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-1. [40 CFR $162.10(h) ( 1) ( iii) ]
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-1. [40 CFR $162.10
-------
(34)
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
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 CPR
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.* Mote that
no signal word is used in conjunction with the flam-
mability statements. i
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(0 (13) (ii) ;
ii. There is no flash back; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350°F (177°C),
determined by the method specified in 40 CFR
Sl63.61-8(c)(13Hi).
-------
(35)
3. Declaration of non-flammability. Products which meet
the criteria for non-flammability 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 physicjal/cfaemical hazard statements. When
chemistry data submitted in accordance with 40 CFR
§163.61-10(1) demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such
statements may address hazards of explosivity,
oxidizing or reducing capability, or mixing with
other substances to produce toxic fumes.
Item 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)1
Item 10A. i 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, 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 claius 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,
-------
(36)
VI. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
[Product Manager]
Phone No. (703)
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
A. For each manufacturing-use 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 III-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 IV-1)»
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 registrants).
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.
B. For each affected product for which continued registration
is desired* within 90 days from receipt of this document
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1r Appendix III-2) with appropriate attachments.
C. 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.
-------
Appendix III-l
(37)
OFFICE OF PESTICIDE PROGRAMS
Registration Standard Bibliography
Citations Considered to be Part of the Data Base Supporting
Registrations Under the standard
MRID 00007445
MRID 00007442
MRID 00019750
GS-0342-001
GS-0342-002
Diversey Corporation (1957) Presence of
Hypobromite in SAP-SOL (PX-829) Solution.
(Unpublished study received Nov. 6, 1957
under 875-42; CDL: 022231-A)
Diversey Corporation (1962?) SAF-SOL as a
sanitizer for use in Food Processing Plants.
(Unpublished study received Feb 18, 1963
under 875-42; CDL: 022229-A)
A.; Carrera, R.T.; Kelley, M.J. (1961) Informa-
tion on conversion rate of Bromide to Hypobromite
in solutions of Diversey PX-1216. (Unpublished
study received Oct. 5, 1961 under 875-45;
submitted by Diversey Chemical Co., Des plains,
111., CDL: 231083-P)
Smith, M.K. (1983) Qualitative Use.
Document for Potassium Bromide
Assessment
EPA (1983) The Calcium and Sodium Hypochlorite
Salts, Pesticide Registration standard part I
(Unpublished)
-------
OMB Approval No. 20004468 (Expires 7.2-3)
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
(38)
PRODUCT NAME
.*PUCANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With rwpect to the requirement to submit "generic" data imposed by the FIFRA section 3(CH2HB) notice contained in the referenced
Guidance Document I am responding in the following manner
D1. I wil submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or ere not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
O 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 date
. requirement! The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
Dl I endose e completed "Certification of Attempt to Emv Into MAgrMinattwftii Other Registrars
i respect to the following deta requirement!:
D 4* I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
D 5. I request voluntary cancellation of the registration of this product (This option is not avaRaUe to applicants for new products.)
r
nEGISTRANTS AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8680-1 (1042)
-------
APPENDIX HI-3
OMB Approval No. 2000-0463 (Ex
(39)
> qualify, certify A LL^ four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
am duly authorized to
tents of a Notice under
to submit data concern! n<
represent the following firm(s) who are subject to the require-
FIFRA Section 3(c)(2)(B) contained in a Guidance Document
3 the active ingredient:
NAME OF FIRM
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
EPA COMPANY NUMBER
My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to ente
nto an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following require
items or data:
My firm hat offered in writing to enter into such an agreement Copies of the offers are attached. That offer was irrevocable and included an offer to b
tound by an arbitration decision under FIFRA Section 3(c)(2){B)(iii) if final agreement on all terms could not be reached otherwise. This offer was mad
to the following firm(s) on the following data(s):
NAME OF FIRM
DATE OF OFFER
lever, none "if those firm(s) accepted mv offer.
"' =M-«»« uwi •_. r-i iiwi au»t,Ciiu me registration is; or my nrm s proauciisr, IT any or tne Tirms named in paragraph (3) abovi
ave agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inforn
« whether my firm must submit data to avoid suspension of its registration^) under FIFRA Section 3(c)(2)(B). (This statemen
ws not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
ED NAME
SIGNATURE
DATE
-------
Appendix
(40)
PSODDCT SPECIFIC DMA REPORT
EEA. Registration No._
_Guidanee Document fcr_
Date
Registration
Guideline No.
SVOOXS
(^lUMI JWpJf
61-1
6l-i
61-3
62-1
62-2
62-3
63-2
63-3
i»3— 4
- - i»_§
6; -6
63-7
63-8
63-4
63-16
63-ii
61-2
&-' 2
43-14
«-: 5
53-8
— O-20
- 83-21
"§1-1
41-3
81-4
ai-s
ai-6
Name of Test
Identity c£
ingredients
Statement of
conoositicn
Discuss icn of
formation of
ingredients
Preliminary
analysis
Certification o£
limits
Analytical methods
limits
rolrr
Physical state
ddcr
Melting point
Boiling point
Density, bulfc-
density, or
specific gravity
Sninfevil-ity
Vapor pressure
Dissociation
constant
Octanol/taater
partition
coefficient
pH
Stahility
Oxidizin9/c«dL>cuig
reaction
riiMintij. ; ,tV
E»plcdab:Jity
Storage stability
VSOMltV
H g^Mlil-yr
characteristics
doun voltage
Acute oral LD-50,
rat
Acute dermal
U>-50
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Parma 1 aeRSitlZa—
ticn
Test not
required
for my
product
listed
above
(check
below)
I an complying with
data requirements by
Citing MRID»
Submit-
ting
Data
(At-
tached)
(Par EPA Ose Only)
Assigned
-------
APPEND I.
Chapter 1 Environmental Protection Agency Sec 162.10
• *v
9162.10 Labeling requirements.
(a) General-(\) Contents of the
label. Every pesticide products shall
bear a label containing the informa-
tion specified by the Act and the regu-
ations in this Part. The contents of a
label must show clearly and promi-
nently the following:
(i) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (0 of this section;
(Hi) The net contents as prescribed
m paragraph
-------
§ 162.10
(iv) The product registration
number as prescribed in paragraph (e)
of this section;
(v) The producing establishment
number as prescribed in paragraph (f)
of this section;
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this
section;
(vil) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(viii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix) The use classificatlon(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility, (1) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary Individual under custom-
ary conditions of purchase and use.
(ii) All required label text must:
(A) Be set In 6-point or larger type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be uted. All required
labelor labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as Is considered necessary to
protect the public. When additional
text in another language is necessary,
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
Ing.
(4) Placement of Label—(i) 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
P?T_\°4 9* use. If the im-
APPENDlf?
Title 40—Protection of Environment
wrapper or outside 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 part of the package as
customarily distributed or sold.
(II) Tank cars and other bulK con-
tainers—(.A) Transportation. While a
pesticide product is in transit, the ap-
propriate provisions of 49 CFR Parts
170-189, concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported in a tank car, tank truck or
other mobile or portable bulk contain-
er, a copy of the accepted label must
be attached to the shipping papers,
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are stored in bulk containers,
whether mobile or stationary, which
remain in the custody of the user, a
copy of the label of labeling, including
all appropriate directions for use, shall
be securely attached to the container
in the immediate vicinity of the dis-
charge control valve.
(5) Falte or misleading statements.
Pursuant to section 2(q)(l)(A) of the
Act, a pesticide or a device declared
subject to the Act pursuant to
, S ,162.16, is misbranded if its labeling is
false or misleading In any particular
including both pesticidal and non-peg-
ticidal claims. Examples of statements
or representations in the labeling
which constitute mlsbranding include:
(i) A false or misleading statement
concerning the composition of the
product;
(ii) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device;
(lit) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device;
(iv) A false or misleading comparison
with other pesticides or devices;
(v) Any statement directly or indi-
rectly implying that the pesticide or
"
(cont'd)
.Copter I—Environmental Protection Agency
162.10
any agency of the Federal Govern*
ment; I
(vi) The name of a pesticide which
contains two or more principal active
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
slated 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;
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regulaf
tions;
(Ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe," "nonpoison-
ous," "noninjurious," "harmless1'- 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 riatural ingredi-
ents":
(B) "Among the least toxic chemi-
cals known" 1
(C) "Pollution approved"
(6) Final printed labeling, (i) Except
as provided in paragraph (a)(6)(ii) of
this section, final p
must be submitted am
to registration. However, final printed
labeling need not be submitted until
draft label texts havefbeen provision-
ally accepted by the Aaency.
(Ii) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such ias those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, on trademark. (1)
The name, brand, or trademark under
which the pesticide product is sold
shall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name cmrsuant to 5 162.B(bU4V
rinted labeling
accepted prior
(c) Name and address of producer,
registrant, or person for whom pro-
duced. An unqualified nair^ and ad-
dress given on the label shall be con-j
sidered as the name and address ol the
producer. If the registrant's name ap-
pears on the label and the registrant is
not; the producer, or if the name of the
person for whom the pesticide was
i produced appears on the label, it must
be qualified by appropriate wording
such as "Packed for • • •," "Distribut-
ed by • • *," 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 icontent shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the
net content statement shall be in
terms of liquid measure at 68° F (20°C)
and shall be expressed in conventional
American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or 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 part of the label
CO
-------
§ 162.10
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—(I) Gener-
al The label of each pesticide product
must bear a statement which contains
i he name and percentage by weight of
each active ingredient, the total per-
centage by weighv 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.
(1) The ingredient statement is nor-
mally required on the front panel of
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 it impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
Titl* 40—Protection of environment
(ii) The text of the ingredient state-
ment must run parallel with other
text on the panel on which it appears,
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement. The name used for each in-
gredient shall be the accepted
common name, if there is one, fol-
lowed by the chemical name. The
common name may be used alone only
if it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25(c)(6).
(4) Statements of percentages. The
percentages of ingredients shall be
stated in terms of weight-to-weight.
The sum of 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
present.
(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
—cnv.ronm.h.ol Protection Agency
inert ingredient(s) to be li.sted in tho
£S=££w=
§ 162.10
w
P'ommenceare
warning statement, the text re
Hazard indicator
OraILD,.
Inhalation LCM...
Dermal LD,.
1 Eye effects
S*m effects
' Toxicily categories " " "" -
L. :' I
Up lo and including 50
fig/kg.
Up lo ana including 2
mg/liier.
Up to and including 200
mg/kg
Corrosive; cornea!
opacity not reve/sible
within 7 days. '
Corrosive '
From 50 Ihru 500 mg/kg
From 2 thru 2 m
-------
£ 162.10
placement of the statement of practl-
:al treatment is some reference such
Is "See statement of practical treat-
ment on back panel" appears on the
iront panel near the word "Poison"
rtnd the skull and crossbones.
~ vB) Other toxicity categories. The
Statement of practical treatment is not
required on the front panel except as
'.-Bribed In paragraph (hXIXiiiXA) of
ins section. The applicant may, how-
, ver. include such a front panel state-
cnt at his option. Statements of
jiactical treatment are, however, re-
,ulred elsewhere on the label in
.ccord with paragraph (hX2) of this
>..-ction if they do not appear on the
i ont panel.
(iv) Placement and prominence. All
•ne require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
co make them unlikely to be over-
ooked under customary conditions of
purchase and use. The following table
nhows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
APPEMDIX V-l
Titlo 40—Protection of Environment {
Sue ot label Iront panel m tquare
inch*.
5 and under ..
Above S lo 10
Above 10 to 15
Above 15 to 30
Over 30
Poi
Requited
signal
word. > . ^
(iii) Exceptions to requirement for' "J
direction for use—(A) Detailed direc-
tions for use may be omitted from la-
beling of pesticides wjiich arp intended
-------
162.10
or use only by manufacturers of pred-
icts other than pesticide products in
heir regular manufacturing processes,
>rovided that:
(7) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
.he type(s) of products Involved.
12} Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product involved and Its
proper use in manufacturing process-
es;
(3) The product will not come Into
the hands of the general public except
.ifier incorporation into finished prod-
ucts; and
<4) The Administrator .determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
U) The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(3) The product Is also a drug and
regulated under the provisions of the
Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products v.:-.ich are intended for
use only by formjl_.v->rs in preparing
pesticides for sale to the public, pro-
vided that:
(1) There is information readily
available to the formulators on the
composition, toxicity, methods of use,
applicable restrictions or limitations,
and effectiveness of the product for
pesticide purposes;
(2) The label clearly strtes 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;
(3) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; and
Tltl* 4O—Protection or Environment
(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":
(i) 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.
(ix) Specific directions concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements of 40 CFR Part 165. These
instructions shall be grouped ana
appear under the heading "Storage
and Disposal." This heading must be
set in type of the same minimum sizes
as required for the child hazard warn-
ing (See Table in I 162.10(h)(l)(iv).)
(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]
^
§162.11
"Reted
appear.
to be necessary
man and
o
or
s
of
of the terms of
a precondition
appear. If Use i*
" shall
on
-
lmP°sed as
sha»
rections only for
the other bearin*
stricted tue^SS
has both restrS
use(s), both of
a product
Me<'} and
for re'
Product
43
32329.
'•
heading "Dle<
erence to the
that suggeste or
eral utility of tt
beyond those pur«>£
tained in the DlreS
considered a fa s
" 5°!? the
And re*-
*en'
extends
con'
wi» be
state-
ae-
ry definitions
ment under the
ofmisbranding
(2) Restricted USP m
Pesticide products hL Clas^cation.
for use(S) c?3?ed^ ?* directi°n
bear statement o "* sha11
Ur
front panel
-------
APPENDIX V-2
LABELING REQUIREMENTS OP THE FIFRA, AS AMENDED (REFER TO TOE SAMPLE LABELS FOLLOWING)
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Est. No.
EPA Rag. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning )
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
-Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements. ^
.p»
&
•^s
-------
APPENDIX V-2 (continued)
ITEM
1C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
practical
treatment
Referral
statement
Side/back panel
precau t ionary
statejnents
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OP REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, .11, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee "?
caution where applicable. Ci
-------
APPENDIX V-2 (continued)
ITEM
8C
9A
9C
10A
IOC
10D
U.S.
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Re-entry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OP REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
All
cholinesterase
inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
statement pf
classifica-
tion or
ahead of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Must be set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units
co
-------
Appendix V-2 (cont'd)
(49)
RESTRICTED USE PESTICIDE
MITIONARY STATEMENTS
IZAROS TO HUMANS
OOMESTC ANM/
DANGER
H3NMENTAL HAZARDS/
SCAL OR CHEMCAL
HAZARDS tff\
•CnONSFOR USEpO
JfTRY STATEMENT
(N Apple**) /
ORY OF APPUCATOR
DRAGE AND
MSPOSAL
g —
U.:
RESTRICTED USE
PESTICIDE
FOR RETAL SALE TO AND APPLICATION ONLY BY
CERTIFIED APPLICATORS OR PERSONS UNDER THEIR
DIRECT SUPERVISION
PRODUCT
NAME
ACTIVE NGREDENT:
MERT MGREDCNTS.
TOTAL;
1OOOO%
THIS PRODUCT CONTAMS LBS OF PER GALLON
KEEP OUT OF REACH OF CHILDREN
DANGER — POISON
STATEMENT OF PRACTICAL TREATMENT
f SWALLOWED:
FNHALED=
FON!
FNEYE5:
SEE SCE PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS
MFC BY
TOWN, STATE .
ESTABLISHMENT NO. =
EPA REGISTRATION NO.
NET CONTENTS:
CROP:
CHOP:
CROP:
CHOP:
CROP:
WARRANTY STATEMENT
-------
(50)
Appendix V-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint, at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80 °F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20 "F.
B. Flashpoint above 20'F
and over 80°F.
C. Flashpoint over 80*F
and not over 150°F.
D. Flashpoint above
150*F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130"F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
-------
(51)
Appendix V~£*
•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:
IRequired type size
Size of label I for the heading
front panel in I STORAGE AND DISPOSAL
square inches I (all capitals)
110 and under 6 point
I Above 10 to 15 8 point
I Above 15 to 30 10 point
I Over 30 . 12 point
Storage and disposal instructions must be set apart and
clearly distinguishable fr,om other directions for use.
Blocking storage and disposal statements with a sol)id line is
suggested as a means of increasing their prominence.
A. Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
.ncluding 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.
-------
(52)
Appendix
(continued)
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. Genera:, storage instructions for household products should
emphasize storage in original container and placement in
locked
storage areas
B. Pesticide Disposal Instructions;
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food,
or feed by storage or disposal." .
j ! ' ' -;
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance."
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
-------
Appendix V
(continued)
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance."
Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
3. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original
container in several layers of newspaper and discard in
trash."
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
A-ll products intended for domestic use must bear one
of the following container disposal statements:
(53)
Container Type
FNon-aerosol products
{(bottles, cans, jars)
1 Non-aerosol products
1 (bags )
I Aerosol products
Statement
Do not reuse container (bottle, can, jar;.
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type
I Metal
I containers
1 (non-aerosol)
1
1
I Plastic containers
I
1
!
|Glass containers
!
Statement
Triple rinse (or equivalent). Then offer i
for recycling or reconditioning, or puncture!
and dispose of in a sanitary landfill, or byl
other procedures approved by state and local I
authorities . 1
Triple rinse (or equivalent). Then orrer i
for recycling or reconditioning, or puncture 1
and dispose of in a sanitary landfill, or I
incineration, or, if allowed by state and
local authorities, by burning. If burned, i
stay out of smoke. '
Triple rinse (or equivalent). Then dispose 1
of in a sanitary landfill or by other
approved state and local procedures. 1
-------
(54)
Appendix V—
(continued)
Container Type
1 Fiber drums
jwith liners
1
1
|
1
1
1
1 Paper and
1 plastic bags
1
1
|
1 Compressed gas
1 cylinders
Statement
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^, dispose of in the same manner.
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.
Return empty cylinder for reuse (or
similar wording).
^Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
2. The labels for all other products must bear container
disposal instructions, based on container type, listed
on the first page of this Appendix.
-------
(55)
Appendix V-#
(continued)
Pesticides that are hazardous wastes under 40 CFR 261.33(e) and (f)
when discarded.
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients, (no inerts);~
Acrolein
Aldicarb
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-dinitrophenol
Dieldrin
OiO-Di'ethyl S-[2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
-------
(56)
Appendix V
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued;
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-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).
-------
Appendix V-# (57)
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List-)
Active Ingredients;
Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)p-thalate
Cacodylic 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
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12*)
3,5-Dichloro-N-(1,l-dimethyl-2-propynyl) benzamide (pronaraide,Kerb)
Dichloro diphenyl dichloroethane (ODD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1,2-Dichloropropane
1,3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
-------
(58)
Appendix V—
(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 Tcetone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene ;dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4,5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Freon 11*)
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2>4,5-T)
Xylene
-------
Appendix V
(continued)
(59)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Inert Ingredients;
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluoromethane (Freon 12®)
Diethyl phthaiate
Dimethylamine
Dimethyl phthaiate
1,4-Dioxane
• Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1,1-Trichloroethane
1,1,2-Trichloroethane
Trichlorofluoromethane (Freon 11®
Vinyl chloride
Xylene
------- |