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W«hingtonDC 20480
December 1985
rWtlCIOM
Guidance for the
Reregistration of
Pesticide Products
Containing
Brominated Salicylanilide
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
AS THE ACTIVE INGREDIENT
BROMINATED SALICYLANILIDE
CASE NUMBER 0347
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
DECEMBER 1985
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TABLE OF CONTENTS
Page
Introduction . . . . 1
I. Regulatory Position and Rationale. 4
II. Requirement for Submission of Generic Data 71
III. Requirement for Submission of Product—Specific
Data . . 90
TV. Submission of Revised Labeling . . 98
A. Label Contents 98
B. Collateral Information . . . . . . .104
V. Instructions for Submission . . . .104
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APPENDICES
Page
Il—i Guide to Bibliography 108
11—2 Bibliography. .. 110
11—3 FIFRA §3(c)(2)(B) Summary Sheet — EPA Form 8580—1 . .111
11—4 Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580—2 112
11 1—1 Product Specific Data Report (End—Use Products) . .113
tv—i 40 CFR 162.10 Labeling Requirements 115
IV—2 Table of Labeling Requirements . . . . .124
IV—3 Physical/Chemical Hazards Labeling Statement. . . .127
IV—4 Storage Instructions for Pesticides 128
IV—5 Pesticide Disposal Instructions 129
IV—6 Container Disposal Instructions 135
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA sec. 3 (g)) directs EPA to reregister all pesticides as
expeditiously as possible.
To carry out this task, EPA has established the Regis—
tration Standards program, which will review all pesticide
products containing active ingredients first registered before
January 1, 1977. Pesticides will be reviewed in use clusters
which have been ranked to give earliest review to pesticides
used on food and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient. EPA ’s reassessment results in the development
of a regulatory position, contained in a Registration Standard,
on each pesticide and its uses. The Agency may require the
registrant to modify product labels to provide additional
precautionary statements, restrict the use of the pesticide
to certified applicators, provide reentry intervals, modify
uses or formulation types, specify certain packaging limitations,
or other requirements to assure that proper use of the pesticide
will not result in unreasonable adverse effects on the environ-
ment.
The scientific review, which is not contained in this
Guidance Package but Is available from the National Technical
Information Service, concentrates on the technical grade of
the active ingredient and identifies missing generic data.
However, during the review of these data we are also looking
for potential hazards that may be associated with the end use
(formulated) products that contain the active ingredient. If we
have serious concerns, we will address end use products as
part of the Registration Standards program and will propose
regulatory actions to the extent necessary to protect the
public.
EPA has the authority under FIFRA sec. 3(c)(2)(B) to
require registrants to submit data that will answer our
questions regarding the hazard that may result from the
intended use of a pesticide. Although sec. 3(c)(2)(B) provides
that all registrants are responsible for these data, the
Agency generally Imposes generic data requirements only on the
registrants of the manufacturing use products (basic suppliers
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of the active ingredient) and other producers who do not
qualify for the formulator’s exemptton.*
A producer who wishes to qualify for the formulator’s
exemption may change his source of supply to a registered
source, provided the source does not share ownership in
common with the registrant’s firm. A registrant may do so
by submitting a new Confidential Statement of Formula, EPA
Form 8570—4, identifying the registered source of the active
ingredient, to the appropriate Product Manager within 90
days of receipt of this Guidance Document. The chart on the
following page shows what is generally required of those who
do and do not qualify for the formulator’s exemption in the
Registration Standards program.
If you decide to request the Agency to cancel the regis-
tration of any of your products subject to the requirements
of this Guidance Document, please notify the Product Manager
named in the cover letter, within 90 days from the receipt
of this document. If you decide to maintain your product
registration(s), you must provide the information described in
the following pages within the timeframes outlined. EPA may
issue a notice of intent to cancel or suspend the registration
of any currently registered product which does not comply
with the requirements set forth in this Guidance Document.
You are reminded that FIFRA sec. 6(a)(2) requires you to
submit factual information raising concerns of possible
unreasonable adverse effects of a pesticide. You should
notify the Agency of interim results of studies in progres
if those results show possible adverse effects.
*The formulator’s exemption applies to a registrant of an
product if the source of his active ingredient(s): (1) is a
registered product and (2) is purchased from a source which
does not have ownership in common with the registrant’s
firm.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulator’s Exemption
A. Single Active Ingredient
Products*
I....
B. Multiple Active Ingredient
Products
These products must be reregis—
tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
.
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
II. Products That Do Qualify For
The Formulator’s Exemption
Only when additional restric—
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, including but not
limited to the Label Improvement
Program and special Intent
to cancel notices.
* End use products of registrants who also produce a manufacturing
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing use product(s). Such end use products
will be subject to the labeling changes required for products in “II”
above. If there are no manufacturing use products registered by any
company end use products will be required to be reregistered.
NOTE: If all registrants in “I” above fail to meet the requirements in
I—A and B above, then the registrants in “II” lose their right to
qualify for the formulator’s exemption and become subject to the
requirements in I—A and B.
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I. REGULATORY ASSESSMENT
A. INTRODUCTION
Registration standards describe the regulatory
position and rationale for all registered
manufacturing—use products (MUPs) containing the
chemical under review as the sole active ingredient.
Normally end—use products (EUPs) are reviewed only
when there are no MUPs registered or when E A
determines that significant changes apply to
end—use products. In the case of the brominated
salicylanilides (also known as bromosalans) the
Agency anticipated that ft would be more efficient
to address both end—use products and manufacturing—
use products at the same time. The three chemicals
in this group, 3 , 4 ’,S—Tribromosaljcylanj ljde
(3,4’ ,5—TBS), 3 ,S—Dibromosa lfcy].aniljde (3,5—DBS),
and 4’,S Dibrotnosalicylanjide (4’,5—DBS) are related
chemically, have similar toxicological concerns,
and are found in combination with one another in a
wide variety of products.
1. Manufacturing—Use Products (MIJPs )
There are two MUPs containing 3,4’,5—TBS in
combination with small amounts of 3,5—DBS and/or
4’,5-DBS, but there are no MUPs for the technical
grade of 4’,5—DBS or 3,5—DBS. There is one
MUP which is a 45/45 mixture of 3,4’,S—TBS and
4’ ,5—DBS.
2. End—Use Products (EUPs )
There are forty—seven EUP’s Federally registered
for use in all states (interstate) and five
EUP’s registered for use only within one
specific state (intrastate). Some of these
are single active ingredient products but the
majority are multiple active ingredient products
containing, in addition to combinations of the
bromosalans, phenolic or quaternary ammonium
germicides.
Future requests for registration of substantially
similar products will be considered under this
standard. Dissimilar products will be evaluated
on a case by case basis; if they are registered
the Agency will amend the standard accordingly.
After briefly describing the chemicals and their
uses, this chapter presents the regulatory position
and rationale, the criteria for registration,
acceptable ranges and limits, and labeling
considerations.
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In developing its regulatory position, the
Agency determines whether available data indicate
that a pesticide has met or exceeded the criteria
for unreasonable adverse effects specified in
Section 1 62 .11(a) of Title 40 of the U.S. Code
of Federal Regulations (CFR). Pesticides meeting
these critleria are candidates for a Special Review,
an intensive risk/benefit analysis. The Agency’s
determination as to whether any criteria have
been met and its rationale for any regulatory
action are summarized in the regulatory position
of this standard.
B. DESCRIPTIONS OF THE CHEMICALS AND THEIR USES
1. Chemical and Physical Characteristics
The brominated salicylanilides also known as
bromosalans are normally derived from salicylic
acid usually in a reaction with aniline in the
presence of phosphorus trichioride In a diluent
(The Merck Index, 9th Ed. 1976). Bromination
is the final step in this synthesis. The
molecular weight of 3,4’,5—TBS is 449.96; for
3,5—DBS and 4’,5 DBS, it is 371.03. 3,4’,5—TBS
is an odorless, colorless white powder with a
melting point of 227—228°C. The samples which
were evaluated under this standard had an
approximate melting point of 214—226°C varying
presumably with the samples’ purity. 3,4’,5—TBS
is soluble in methanol, ethanol, isopropanol,
ethyl ether and benezene (0.5—4.0%); sparingly
soluble in chloroform and cyclohexane (0.01—0.5%);
insoluble in water and petroleum ether.
The bromosalans are used as antimicrobials and
fungicides. 3,4’,5—TBS is sold under the
trade name Tempasept and is also referred to
as Tribroinsalan. The Chemicals Abstract Service
(CAS) Registry Number is 87—10—5 and the EPA/OPP
Pesticide Chemical Code No. is 077404. 3,5—DI3S
has a CAS No. of 2577—72—2 and an EPA/OPP No. of
077405. 4’,S—DBS has a CAS No. of 87—12—7 and an
EPA/OPP No. of 077402.
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2. Registered Uses
The primary registered uses for the bromosalans
are as germicides for nonfood contact hard
surfaces and equipment in commercial and
industrial areas, eating establishments, homes
and hospital premises; as fungicides for the
control of mold and mildew in bathrooms,
schools, homes and hospitals; and as antimicrobial
preservatives in laundry additives, textiles,
manufactured products, and exterior latex paints.
There are no registered uses of the bromosalans
involving direct application to agricultural
crops or to food or feed.
C. REGULATORY POSITION AND RATIONALE
Data are lacking to fully assess the registered
uses of the bromosalans. Based on the review and
evaluation of what little data are available and
other relevant information on the bromosalans,
the Agency has made the following determinations.
1. Risk Criteria Assessment
There are no data available to the Agency to
establish whether or not the risk criteria
listed in Section 162.11(a) of Title 40 of the
U.S. Code of Federal Regulatior s have been met
or exceeded for the registered uses of the
bromosalans. Hence registrants must submit
a substantial amount of data as specified in
the data tables of this document.
Rat ionale
Part of the registration standard process is
to re—evaluate available data on the active
ingredient(s) to determine whether such data
will continue to support the registered uses
without unreasonable adverse effects on humans
and the environment and thus determine whether
the risk criteria of § 162. 11(a) of 40 CFR have
been met or exceeded. In those instances
where there are no data available to make this
determination, the Agency identifies the
required data and allows reasonable time to
provide the data to make such a determination.
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2. Human Toxicity Concerns
(a) Manufacturing-use Products
To maintain current registrations as well as
register new products or reregister currently
registered products, the data specified in
the Table A and Table B toxicity data
requirements must be submitted. This
would initially consist of the basic acute
labeling and user protection data, teratology
studies, a 21—day subchronic dermal study,
and a mutagenic battery for the technical
grade of each active ingredient. For
those products used as textile biocides,
exposure, leachability, and dermal penetra-
tion studies will also be required.
(b) End—Use Products
Registrants of EUPs covered under this standard
will be required to submit the product specific
acute toxicity data specified in the Table C
toxicology requirements.
Rationale
There are no toxicity data available for
the manufacturing—use product containing
bromosalans. Since the uses of the bromo—
salans as household and hospital disinfectants
may result in repeated dermal exposure,
teratology, 21—day subchronic dermal, and
mutagenic studies are being required in
addition to the basic acute studies. A
requirement to develop long—term chronic
toxicity data is being reserved pending the
results of these studies.
The three bromosalans also have varied uses
which would be covered by the proposed policy
for registration of textile biocides as
published in the Federal Register, Vol. 47,
No. 240, pp 55967—55970, December 14, 1982.
For those uses exposure estimates or determina-
tions must be submitted to demonstrate what
exposure is likely or not likely to occur under
the conditions of use. These estimates may be
based on actual studies or on scientific rationale.
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If the intended uses as textile biocides have
the potential for direct body contact, then
leachability studies from different fabrics
(e.g. cotton, synthetics) via perspiration,
urine, laundry washing, dry cleaning, and effect
of pH are required. These studies should be
performed with a typical pesticide formulation —
i.e. an end use product not on three different
technical grade chemicals — containing all three
active ingredients preferably at the highest
percent allowed on any product that bears labeling
for use as a textile biocide. If any of the
three active ingredients leaches in any amount,
then a determination of the dermal penetration
of that Ingredient using a radiolabeled mixture
must be conducted. If there is no leaching,
then a request for a waiver of the penetration
studies would be appropriate.
Protocols for determining exposure, leachability,
and dermal penetration must be submitted to the
Agency for review, prior to the initiation of
these studies, no later than 120 days from the
date of this standard, and the actual data must
be submitted no later than 12 months from the
date of notification by the Agency to proceed with
the studies.
Since the EUPs addressed by this standard contain
a wide variety of active and inert combinations
and data on one formulation cannot be extrapolated
to support another formulation, product specific
acute toxicity data will be required for each
product covered by this standard.
3. Exposure Assessment Concerns
(a) Manufacturing—Use Products
Data on hydrolysis and photodegradatiort in water
are required for the technical grade of each
active ingredient.
(b) End—Use Products
No product specific environmental fate data
will be required.
Rationale
There are no environmental fate data avail-
able for the bromosalans. Based on the
registered uses of these products as
disinfectants, laundry additives, textile
preservatives, and manufactured products,
discharge of these chemicals into public
waters, lakes, and streams is possible.
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Therefore, the Agency requires these data
to evaluate the type and persistence of
residues of these chemicals in the aquatic
environment.
Environmental Fate data on the end—use product
are only required if any of the registered uses
will cause additional exposure concerns to non—
target organisms which cannot be assessed by
data developed on the technical grade of the
active ingredient. This is not the case with
any of the registered uses of the bromosalans.
4. Groundwater Contamination
There is a possibility of contamination of
groundwater by the bromosalans.
Rationale
Even though all the registered uses covered by
this standard are indoor, due to the nature of
these uses as noted under (C)(3) above, ground-
water contamination is possible. The submission
of the required environmental fate data for the
technical grade of the active ingredient will
enable the Agency to more fully address this
issue.
5. Ecological Effects Concerns
(a) Manufacturing—Use Products
An avian dietary LC 50 , a freshwater fish
LC 50 , and a freshwater invertebrate LC 50
will be required for the technical grade of
each active ingredient.
(b) End—Use Products
No product specific fish and wildlife data will
be required.
Rationale
There are no fish and wildlife data available
for the bromosalans. As noted above under
(C)(3), the registered patterns of use are
such that these chemicals may be discharged
into the environment. While the production
of this material is small and the possibility
of exposure is limited, a minimal amount
of fish and wildlife data is necessary to
assess the potential hazard of these chemicals.
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Fish and Wildlife data on the end—use product
are only required if any of the registered uses
will cause additional exposure concerns to non—
target organisms which cannot be assessed by
data developed on the technical grade of the
active ingredient. This is not the case with
any of the registered uses of the brornosalans.
6. Endangered Species Consideration
The bromosalans should not pose a hazard to
endangered species.
Rationale
All the uses covered by this standard are indoor.
7. Product Chemistry Concerns
(a) Manufacturing—Use Products
To register new products, the data specified
in the Table A and Table B product chemistry
data requirements must be submitted.
In addition to the requirements of 40 CFR 158.120,
the following additional information is required
to supplement the manufacturing procedure required
for the technical grade of 3,4’,5—TBS, 3,5—DBS, and
4’ 5—DBS.
o A statement of whether the process is a batch
or continuous process.
o The composition of the beginning materials and
order in which they are added.
o A description of the equipment used to produce
the product which may influence the product’s
composition.
o A description of the physical conditions which
are controlled during each step of the process
in order to influence the product’s composition.
o A flow chart listing chemical equations of each
chemical reaction.
o The duration of each step of the process.
o A description of any purification procedures.
o A description of quality control measures.
o An indication of whether or not the registered
technical or manufacturing use products are the
products of synthesis and/or blending.
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(b) End—Use Products
Each EUP covered under this standard will be
required to submit the product specific basic
chemistry data specified in the Table C product
chemistry data requirements.
Rationale
The available product chemistry data are
insufficient to satisfy the basic chemistry
data requirements for the bromosalans. This
consists of an out—of—date 1959 description
of the manufacturing process submitted for
3,4’,5—TBS,’/ and data on the physical and
chemical properties of “essentially pure”
3,4’5—TBS, containing about 5% 3,5DBS and
essentially free of 4’5—DBS 2 /. No data are
available for the technical grade of 3,5—DBS
and 4’,5—DBS.
Discussion of the formation of impurities has
not been provided nor is there any up—to—date
information available on the preliminary analysis
of commercially available chemicals. For the
technical grade of each active ingredient, a
discussion addressing the impurities likely to
be present in amounts of 0. 1% or more and the
highly toxic impurities which may be present in
any amount is required.
Since the EUPs addressed by this standard contain
a wide variety of active and inert combinations,
product specific basic chemistry data will be
required for each product covered by this standard.
D. CRITERIA FOR REGISTRATION UNDER THIS STANDARD
To be registered under this standard, products must
contain either 3,4’,5—TSS, 3,5—DBS, or 4’,S—DBS or
combinations of these ingredients as active ingre-
dients, conform to the product composition, acute
toxicity limits, use pattern requirements, and the
required labeling as prescribed in various sections
of this standard, in addition to those prescribed in
Section F of this chapter.
1/ Hexcel Corporation MRID No. 00043906
2/ Dow Chemical Company MRID No. 00042949
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Applicants for registration or reregistration and
registrants of products under this standard who
wish to maintain their registrations in effect
before reregistration must comply with all terms
and conditions described in it, including submission
of an up—to—date Confidential Statement of Formula,
submission of revised labeling, and a commitment
to fill data gaps and where applicable pay compen-
sation as required by FIFRA Sections 3(c)(1) and
3 (c)(2) on the schedule specified in this document.
Registrants of end—use products who do not qualify
for the Formulator’s Exemption must satisfy labeling,
packaging and data requirements in accordance with
this guidance package.
E. ACCEPTABLE RANGES AND LIMITS
I. Product Composition
(a) Manufacturing—Use Product
The technical grade of 3,4’,5—TBS has been
defined by this standard as material containing
at least 957. 3,4’,S—TBS, 5% 3,5—DBS, and essentially
free of 4,5—DBS. Applicants who wish to register
a technical grade of 3,4’,5—TBS differing in
composition from this material must satisfy
whatever additional data requirements apply
to such modifications. If such products are
registered the Agency will amend the standard
to include such products.
No information is available for the technical
grade of 3,5—DBS or 4’,5—DBS. Applicants who
wish to register, under this standard , pesticide
products containing these chemicals must submit
the product chemisty data as discussed under
(C)(7) above and satisfy all other requirements
for technical grade and manufacturing—use
products discussed elsewhere in this document.
(b) End—Use Products proposed for registration under
this standard must be substantially similar to the
products listed in the EPA Index to Pesticide
Chemicals which lists the formulations approved for
the brominated salicylanilides. A product will
be considered substantially similar to a registered
product if it contains the same active ingredients
at approximately the same concentrations.
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2. Acute Toxicity Limits
(a) Manufacturing—Use Product8
The Agency will consider registration or re-
registration of technical grade products and
manufacturing—use products containing 3,4’,5—TBS,
3,5—DBS, or 4’,5—DBS for any proposed acute
toxicity categories, provided that the registrant
submits the data necessary to establish the toxicity
category for each route of exposure, thereby permit-
ting the Agency to prescribe appropriate precautionary
statements consistent with 40 CFR §162.10.
(b) End—Use Products
The Agency will consider registration or re-
registration of end—use products containing
3,4’,5—TBS, 3,5—DBS, or 4’,5—DBS provided that
acute toxicity data specific to the particular
end—use product is submitted. This is required
to establish the acute toxicity categories
for those potential routes of exposure, and thus
enable the Agency to prescribe appropriate
precautionary statements in accordance with Section
162.10 of 40 CFR.
3. Use Patterns
(a) Manufacturing—Use Products
To be registered under this standard, tIUPs must
be labeled for formulation or repackaging as
disinfectants, sanitizers, fungicides, preserva-
tives, or additives for the control of the pests
listed in the EPA Index to Pesticide Chemicals
which lists the uses, sites, and pests which have
been approved for the brominated salicylanilides.
(b) End—Use Products
EUPs can be registered under this standard if
the proposed uses, sites, and pests have
been previously accepted. For a use not
covered under this standard, the applicant
must submit all data necessary for EPA to
determine whether to approve the application.
If the application is approved, EPA will
issue a supplement to the standard.
F. REQUIRED LABELING
All manufacturing—use pesticides and end—use pesticides
must bear appropriate labeling as specified in the
general labeling requirements of Section 162.10 of 40 CFR.
For more details on these requirements see Chapter V and
Appendix IV—1 of this standard. The following specific
requirements apply to the labels for the brominated
salicylanilides.
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I. Ingredient Statement
The ingredient statement for manufacturing—use
pesticides and end—use pesticides must appear on the
front panel as follows:
ACTIVE INGREDIENTS
(Name of Ingredient)................. %
(Name of Ingredient) ........
INERT INGREDIENTS. .
2. Use Patterns
The label for all manufacturing use products must
state that they are intended for formulating
or repackaging pesticides which must be registered
for the sites and pests listed in the EPA Index to
Pesticide Chemicals. A limiting 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 Table A, Table B or Table C of this standard for
that use pattern. Labels for MUPs are not required
to bear complete directions for use of the pesticide.
They are required to comply with the labeling
requirements of Section 162.10(I)(1)(iii) of 40 CFR.
3. Precautionary Statements
(a) Manufacturing—Use Products
(I) Labels for all manufacturing—use products
containing a brominated salicylanilide
must bear statements reflecting the product’s
acute human toxicity as explained previously
In 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 effluent containing
this active ingredient into lakes,
streams, ponds, estuaries, oceans, or
public waters unless this product is
specifically identified and addressed
in an NPDES 1 / permit. Do not discharge
effluent containing this product to sewer
systems without previously notifying the
sewage treatment plant authority. For
guidance contact your State Water Board or
Regional Office of the EPA.
!/ National Pollution Discharge Elimination System
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(iii) Depending on the results of the ecological
effects data required to register the MUP,
the label may require a fish and/or wildlife
hazard statement, as specified in Section
162.lO(h)(2)(ii) of 40 CFR. For the data
requirements see Table A, Generic Data
Requirements.
(b) End—Use Products
Labeling for each end—use product must bear appro-
priate precautionary statements specific for the
product as formulated. These statements must
reflect the acute toxicity categories 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 C,
Product Specific Data Requirements.
C. TOLERANCE REASSESSMENT SUMMARY
No data are required to establish a tolerance or an
exemption from the requirement of a tolerance.
Rationale
The registered uses for the bromosalans are not likely
to result in residues in food or feed, hence no data
are required to establish a tolerance or an exemption
from the requirement of a tolerance.
Registrants who propose such uses must satisfy the
data requirements to establish a tolerance. If the
tolerance is established the Agency will amend the
standard accordingly.
H. INCIDENTAL FOOD ADDITIVE ASSESSMENT
Products containing the bromosalans (i.e. bromo—
salicyl.anilides) will not be registered under this
standard for use as a terminal sanitizing rinse on
food contact surfaces in establishments engaged in
processing or preparing food for consumption by the
general public , unless they are cleared for this use
in accordance with the provisions of Section 178.1010
of TitLe 21 of the Code of Federal Regulations within
a year of the date of issuance of this standard.
Rationale
Antimicrobial agents which are recommended or sold to
control the growth of microorganisms of public health
concern on inanimate surfaces are defined as pesticides
under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and, therefore, must be registered with
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the Environmental Protection Agency (EPA). However,
pesticides recommended for this use are also
identif Ied as incidental food additives under the
Federal Food, Drug, and Cosmetic Act (FFDCA) and,
therefore, must comply with the regulations at 21
CFR §178.1010, governing sanitizing solutions, which
are administered by the Division of Food and Color
Additives of the Food and Drug Administration (FDA).
The Food and Drug Administration exercises authority
over establishments which are engaged in the business
of processing or preparing food for consumption by
the general public, such as restaurants, food processing
plants, dairies, soft drink plants, breweries, etc.
To ensure that food processed or prepared in such
establishments is not contaminated with microorganisms
which may be injurious to the public, the FDA requires
that food processing equipment, utensils, and food
contact surfaces be precleaned and washed to remove
gross filth and food particles, rinsed with water to
remove traces of detergent, and rinsed with a terminal
sanitizing solution .
Such solutions may only contain antimicrobial agents
and other chemical ingredients at specified concentra—
tions as approved at Section 178.1010 of 21 CFR; and
treated utensils, equipment, and surfaces must be
allowed to dry adequately by drainage (air dried)
before they are used.
Products which are now being used or recommended as
sanitizing solutions to treat food contact surfaces,
and which bear label recommendations to follow such
treatment with a potable water rinse negate the purpose
and intent of the treatment and will no longer be
allowed. Furthermore, a potable water rinse may
recontaminate the sanitized surfaces with bacteria
which may be present in the water, thus introducing
a risk to public health. Hence, the use of an
antimicrobial at the sanitizing level of activity on
food contact surfaces is defIned as a terminal sanitizing
rinse; and although the EPA has approved antimicrobial
labels for this use in the past with a potable water
rinse recommendation, such labels will no longer be
approved.
I. EFFICACY EVALUATION SUMMARY
No product specific ‘microbiological efficacy data
were evaluated for the bromosalans.
16
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Rationale
The only data normally required by the Agency for
manufacturing—use products which are to be reformulated
into antimicrobials is presumptive evidence of their
effectiveness. Since the bromosalans have been widely
used as antimicrobjals for many years, this presumptive
evidence has already been established and no data will
be required for MUP’s.
Nor will efficacy data be required for products
bearing claims for effectiveness against
microorganisms of economic or aesthetic significance.
Such claims are defined as non—health related and the
Agency has waived product performance data for these
uses.
Section 162.18—2(d)(2) of 40 CFR requires that
“efficacy data specific to each product that bears a
claim to control organisms that may pose a threat to
human health, either directly or through transmittal
of disease” must be submitted to support the registra-
tion of such a product. 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.
The specific data requirements for end—use products
intended to provide health related benefits and the
conditions under which the Agency will evaluate
previously submitted efficacy data are explained
in the Standard Efficacy Chapter which directly
follows this section.
17
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STANDARD EFFICACY CHAPTER - REGISTRATION STANDARDS
ANTIMICROBIAL AGENTS
GENERAL CONSIDERATIONS
Section 3 (c)(5)(D) of the Act provides that the Admin-
istrator may waive data requirements pertaining to efficacy
of a product under consideration for registration, and hence
by inference reregistration, and that if he waives the require-
ment for data, he may also waive the finding of efficacy
required by FIFRA section 3(c)(5)(A). A selective waiver of
data by the Administrator has been adopted for non—human—health
related pesticides as Agency policy in order to relieve the
internal resource burden associated with the review of product
performance data. In addition, the selective waiver of efficacy
data has been implemented in response to the intent of Congress
to reduce the regulatory burden of the affected industry.
It must be clearly understood, however, that the
Agency shall continue to expect all registrants to perform
those studies necessary to assure that non—human health
related products entering the marketplace will perform their
intended function(s) when applied in accordance with label
directions and commonly accepted pest control practices.
While relying upon the integrity of the industry, the Agency
does anticipate occasional imperfections in the marketplace
self—regulation. The Agency, in this regard shall assume a
conditionally passive stance; maintaining a passive role
until such time as monitoring or in—house technical expertise
triggers a potential efficacy problem. Upon analysis of the
validity and impact of the issue, the Agency may choose to
remain passive, adopt a market assistance posture, or adopt a
presumptive posture dependent upon the product attributes or
the nature and significance of the concern. To this end, the
Administrator shall reserve the right to request submission
of efficacy data in support of label claims for any registered
product. A request, under the authority of 3(c)(2) (B), may
be made for any product for which a pattern of inadequate
performance has been reported. Should such a request be
tendered, the request may be satisfied through the submission
of data developed in accordance with the Pesticide Assessment
Guidelines, Subdivision G, Product Performance, Series 91:
Efficacy of Antimicrobial Agents, Subseries 91B: NON— PUBLIC
HEALTH USES , EPA Document Number 540/9—82—026, November 1982
available from the National Technical Information Service,
Springfield, VA, NTIS Order No PB 83—153924.
18
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Other regulatory considerations that must be noted for
non—health related antimicrobial pesticides include:
1. FDA Regulations at 21 CFR 173.320 for antimicrobial
agents used in sugar mills.
2. FDA Regulations at 21 CFR 176.300 for slimicides
used in the manufacture of paper and paperboard
that contact food.
3. FDA Regulations at 21 CFR 175.105 for preservatives
used in adhesives intended for use in the packaging
of food.
4. FDA Regulations at 21 CFR 173.315 for chemicals used
in washing or to assist in the lye peeling of fruits
and vegetables.
5. Fuel Additives:
(A) If the use is for aviation fuel, clearance is
required from the Federal Aviation Administration.
(B) If the use is for motor vehicle gasoline, diesel
fuel, or engine oil, the product must be register-
ed with the Office of Fuel and Fuel Additive
Registration, EPA.
The Agency, in response to public comment and internal
deliberation, has limited its direct area of concern to, and
shall maintain a continuing efficacy data submission require-
ment for certain health—related use patterns. With respect to
registration, the Agency will require product performance data
in support of public health uses. A public health use exists
whenever the continued presence of a target pest organism may
pose a threat to health, either by direct action or through
transmittal of disease. The definition for public health uses
shall be further limited to include only those uses for which
the Agency believes there are inadequate marketplace controls,
and for which there appears to exist a low order of user
recognition of product performance. Such uses include antimi-
crobial use patterns. Performance data will be required for
all antimicrobial products intended to control microoganisms
infectious to man in any area where these microorganisms may
present a health hazard.
19
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The following criteria will be utilized to determine whether
or not the labeling of an antimicrobial pesticide bears uses of
human health/public health significance:
PUBLIC HEALTH SIGNIFICANCE/SUPPORTING DATA REQUIRED :
1. Products bearing claims for control of micro—
organisms infectious for man will be considered
as directly related to human health and will
require specific and complete efficacy data to
support such claims and patterns of use.
2. Unqualified and non—specific claims for products
as sterilizers, disinfectants, or sanitizers will
be considered to include or imply effectiveness
against microoganisms infectious for man. Antimi-
crobial products recommended for use in hospital
or medical environments, including sickrooms in
public or private dwellings, will be similarly
considered as human—health—related, and efficacy
data will be required.
3. Hospital sterilizers and disinfectants, swimming
pool water disinfectants, human drinking water
disinfectants and purifiers, and food—contact
surface sanitizers are, by their very nature,
human health—related and will require efficacy
data whether or not control of specific infectious
microorganisms are claimed.
4. veterinary and animal premise disinfectants will
require efficacy data to support claims against
those microorganisms which are infectious for
both man and animals.
NON-PUBLIC HEALTH SIGNIFICANCE/NO SUPPORTING DATA REQUIRED :
1. Algaecides, slimicides, preservatives, deodorizers,
and other products expressly claiming control of
microorganisms of economic or aesthetic significance
not directly related to human health will not require
efficacy data.
2. Products bearing claims for effectiveness at the
hacteriostatic level (inhibition of growth) are
not acceptable for health—related use patterns.
Bacteriostatic claims are only permitted for
products.
20
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expressly recommended for control of microorganisms
of economic or aesthetic significance, not directly
related to human health and therefore, will not
require efficacy data. (e.g. slime—forming bacteria,
odor—causing bacteria).
3. Veterinary and animal premise disinfectants will
not require efficacy data for claims against micro-
organisms which are infectious only for animals.
4. Manufacturing use products for the formulation of
antimicrobial pesticides only, will not require
efficacy data unless end—use recommendations are
made (dosages; claims; recommended formulations).
21
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SPECIFIC CONSIDERATIONS
EFFICACY DATA NOT REQUIRED :
Those patterns of use recorded upon current labeling
for products containing brominated salicyanilide as the
active ingredient, that fall within the non—human health—
related use category for which efficacy data submission
and review are waived, need not be supported by efficacy
data submission or reference.
EFFICACY DATA REQUIRED :
II Those patterns of use recorded upon current labeling
for products containing brominated salicyanilide as the
active ingredient that fall within the non—waivable,
human health—related use category must be supported by
efficacy data submission.
Section 162.18—2(d)(2) of 40 CFR requires that effi—
cacy data specific to each product that bears a claim
to control organisms that may pose a threat to human
health, either directly or through transmittal of disease”
must he submitted to support the registration of such a
product. Each antimicrobial product intended to control
microorganisms infectious to man in any area where these
microorganisms may present a health hazard falls under
the requirements of this section. Microbiological effi-
cacy data are product specific; data for one product can
not be used to support registration of another product
unless the two products are identical in composition,
use pattern, claims, dosages. Even then, confirmatory
data is required to register a product relying on data
developed with another product. The Agency has determined
that the nature of these products is such that performance
is intimately linked to and dependent upon not only the
final concentration of identified active ingredients,
but also the inert constituents of the complete formula,
the manufacturing process, raw material quality, etc.
It is for these reasons that formulation specific
efficacy data must be demanded for each product proposed
for reregistration. Such data shall be submitted for
review at the time of submission for reregistration.
22
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The specific, current efficacy data requirements (test
methodology and performance criteria) for end—use products
intended to provide human health—related benefits can be
found in the guidelines for product performance:
Pesticide Assessment Guidelines
Subdivision G, Product Performance, Series 91:
Efficacy of Antimicrobial Agents, Subseries 91A,
Public Health Uses
Available from National Technical Information
Service, Springfield, VA 22161
EPA Document Number 540/9—82—026, November 1982
Order No. PB 83—153924
Other regulatory considerations that must be noted for
health—related pesticides include:
Products proposed for use as final sanitizing
rinses on food contact surfaces, food handling
equipment, and eating utensils in food processing
establishments, must comply with FDA Regulations
at 21 CFR 178.1010.
2. Products recommended for use in federally inspected
food processing plants must be authorized for such
use under the USDA (U.S. Department of Agriculture)
Inspection and Grading Program.
3. Products recommended for use on certain medical
devices, such as hemodialysis equipment, are also
required to be approved by the Office of Device
Evaluation, Center for Devices and Radiological
health, FDA.
4. The new use of an active ingredient for sanitization
of hatching eggs may require approval as a new
animal drug by the Bureau of Veterinary Medicine,
FDA.
5. Products recommended as sartitizers for food grade
eggs must meet the same criteria as for use on
food contact surfaces, FDA Regulation at 21 CFR
178—1010.
23
-------
Additional specific guidance is available concerning current
efficacy data requirements in the DIS/TSS Enclosures listed
below and available from the Disinfectants Branch,
Registration Division:
1. Efficacy Data Requirements — Disinfectants
2. Efficacy Data Requirements — Supplemental Recommendations
3. Efficacy Data Requirements — Reporting of Data
4. Efficacy Data Requirements — Sanitizing Rinses(for
previously cleaned food—contact surfaces)
5A. Confirmatory Data Requirements — Duplicated product
formulations.
5B. Confirmatory Data Requirements — Product formulations
identical to a registered product. Formulations
produced by simple dilution of registered concentrates.
6. Efficacy Data Requirements — Supplemental Efficacy
7. Efficacy Data Requirements — Virucides
8. Efficacy Data Requirements — Carpet Sanitizers
9. Efficacy Data Requirements — Sterilizers
10. Efficacy Data Requirements — Sanitizer Test
(for inanimate, non—food contact surfaces).
11. Efficacy Data and Labeling Requirements — Air Sanitizers
12. Efficacy Data Requirement — Swimming Pool Water
Disinfectants.
13. Efficacy Data Requirements — Laundry Additives/
Disinfection and Sanitization.
14. Efficacy Data Requirements — Laundry Additives/Residual
Self—Sanitizatiori and Bacteriostasis.
Efficacy Data Requirements — Pre—saturated or Impregnated
Towelettes for hard Surface Disinfection.
Efficacy Data Requirements — In—Tank Sanitizer Products
24
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Testing Requirements for Alkaline Glutaraldehyde Products
Reuse Testing of Sterilant/Disinfectant Solutions
Efficacy Data Requirements — Water Purifier Units
Efficacy Data Requirements — Emergency Water Supplies
EFFICACY DATA SUBMISSIONS FOR REREGISTRATION
Over the past several years, products relying on basic
efficacy data developed prior to revision of the efficacy
data requirements were permitted to retain label claims and
registration, in certain situations. However, registrants
were informed that at the time of reregistration compliance
with the updated efficacy data requirements would be required.
Therefore, for reregistration, only efficacy data developed
in accordance with the current data requirements expressed in the
Pesticide Assessment Guidelines and the DIS/TSS Enclosures will
be considered for review in support of reregistration.
If efficacy data meeting the current requirements has been
previously submitted, assigned an Accession Number, been reviewed,
and accepted, the application for reregistration should identify
the Accession Number, Date of Submission, Title of Study and
Laboratory who conducted the study.
If previously submitted efficacy data does not meet the
current requirements, it will not be considered in support of
reregistration and should not be submitted. New efficacy data,
developed according to current requirements must accompany
the application for reregistration.
25
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EPA Index to Pesticide Chemicals
a077 4 0 2 4’ ,5—DIBROI4OSALICYLANILIDE
and
a07740 4 3,4’ ,5—TRIBROMOSALICYLANILIDE
and
a07 7405 3, 5—DIBROMOSALICYLANILIDE
and
OTHER ACTIVE INGREDIENTS
TYPE PESTICIDE : Antimicrobial, Fungicide
FORMULATIONS :
Fl (90%, 99%, 100%)
Impr (0.2%)
SC/S (0.15%, 0.6%, 79%, 99%)
SC/L (0.02%, 0.1%, 0.25%, 2%, 3%, 3.1%, 3.11%, 6.2%)
RTU (0.05%, 0.2%, 5%, 10%, 15%, 100%)
PrL (0.001.4%, 0.0134%, 0.02%, 0.025%, 0.05%, 0.2%, 0.36%, 0.7%, 1%)
PRESENTATION OF INFORMATION : All final concentrations are expressed in
parts per million (ppm) total active ingredient(s) or ppm available quater—
nary ammonium compound. Concentrations are rounded to the nearest whole
number when the value is less than 1,000 and to the third significant fig-
ure when the value is greater than 1,000. Unless otherwise stated, the
dilutions are the ratio of the volume of the product to be diluted to the
volume of fluid in which the product is diluted. The dilutions are rounded
to the nearest whole number. In some instances, dosages are given as
weight of product based on the total weight of the material being treated.
When bromosalicylanilides are formulated with quaternary ammonium compounds
or other active ingredients, separate ppm calculations are given in the
following order: 1) bromosalicylanilides, 2) quaternary ammonium com-
pounds, and 3) other active ingredients.
GENERAL WARNINGS AND LIMITATIONS : For claims/uses against microorganisms
of significance for human health, efficacy data is formula specific (in-
cluding inerts) and cannot be extrapolated.
Refer to individual sites for general warnings and limitations that are
specific for that particular site.
Do not mix any product containing a quaternary arnmonium compound in its
formulation with soaps or anionic detergents as these mixtures will reduce
the effectiveness of the product. Products containing quaternary ammonium
compounds should ot be mixed with other chemicals, particularly oxidiiing
agents such as chlorine, since such mixtures can form potentially explo-
sive compounds. Hard water may reduce the effectiveness of products con-
taining quaternary ammonium compounds.
Phenolic products should not be mixed with anything but water. For best
results, add water to the product.
Note all cautions concerning products under pressure. Do not puncture or
incinerate containers. Do not use near heat or open flame. Do not expose
to temperature above 1.20 F (48.9 C).
Issued: 3—11—85 V.1—077402—I
26
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EPA Index to Pesticide Chemicals
GENERAL WARNINGS AND LIMITATIONS (continued)
Apply product only as specified on the label and technical data sheets.
Read labels very carefully for specific warnings, human toxicity state-
ments, and environmental cautions.
Follow label directions for the disposal of the product container when
empty.
Definition of Terms :
a.i. — active ingredient
ppm — parts per million
quat — quaternary ammonium compound
Site, Efficacy, Use Directions
Dosage and Formulation
AQUATIC NON-FOOD
( Aquatic Sites )
/65011MB—2 Swimming Pool Related
Surfaces, Shower Rooms
and Locker Rooms
General Instructions for Use The products regis-
tered in this site are intended for use on locker
room, shower room, and swimming pool related sur-
faces. Swimming pooi related surfaces include
bathhouse surfaces, diving boards, ladders, pool—
side surfaces, runways, walkways, and other areas
around swimming pools commonly contacted by bare
feet.
Precleaning of surfaces to remove soil and filth
deposits is usually recommended. Observe required
contact time. Apply solutions to surfaces by mop,
swab, spray, or brush.
A24 Bacteriostat
348 ppm Bacteriostatic treatment for surfaces.
347 ppm Formulated witti N—lauryl diethylenetriamine.
(3 . SC/L)
A22 Disinfectant
A24 Deodorizer
FYABQBB Mold/mildew
450 ppm Disinfection and mold/mildew control on surfaces.
1,500 ppm Formulated with o—phenylphenol and 4—chloro—2—
(O.045 PrL) cyclopentyiphenol.
Issued: 3—11—85 V.1—077402—2
27
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
INDOOR
( Pets and Domestic Animals)
( Animals and Their Man—made Premises )
/53010GA Fishing Equipment
General Instructions for Use : The product regis-
tered in this site is for use on fishing equipment.
Spray with product from a distance of 6 to 8 inches
for 3 seconds until surface is wet. For mold/mil-
dew control, preclean surface and repeat applica-
tion weekly.
A18 Pseudomonacide
Al9 Tuberculocide
A22 Disinfectant
A24 Deodorizer
A25 Virucide—effective against Influenza Type A2 virus
FYABQBB Mold/mildew
3,600 ppm Disinfection and mold/mildew control on equipment.
550,000 ppm Formulated with ethyl alcohol, o—phenylphenol, and
(0.367. PrL) 4—chloro—2—cyclopentylphenol.
/54000JA—l Kennels and Pet Animal
Quar ters
General Instructions for Use: The products regis-
tered in this site are for use in cat, dog, bird,
rodent, fish, amphibian, and reptile living and
sleeping quarters, equipment, and litter trays.
All surfaces must first be cleaned of gross filth
and used litter by scrubbing with soap or deter-
gent, followed by a clear water rinse. The diluted
or full, strength product is then applied to sur-
faces by mop, spray, scrub, or brush. Allow treat-
ment to dry. Feeding and watering equipment must
be thoroughly rinsed with potable water prior to
reuse. Kennels and quarters should be thoroughly
ventilated before animals are returned to them.
For mold/mildew control, preclean hard non—porous
surfaces prior to treatment when required. Apply
by sponge, cloth, mop, or spray. Allow to dry.
Do not rinse. Repeat periodically or when mold/
mildew growth appears.
Issued: 3—11—85 V.1—077402—3
78
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EPA Index to Pesticide Chemicals
Site, Efficacy,
Dosage and Formulation
Use Directions
Kennels and Pet Animal Quarters (continued)
Pseudomonacjde
Tuberculocide
Disinfectant
Deodor izer
Virucide—effectjve against Influenza Type A2 virus
Fungicide
Mold/mildew
14 ppm
3,400 ppm quat
421,000 ppm
(0.0014% PrL)
2,000 ppm
2,500—5,000 ppm
quat
445,000—629,000 ppm
(0.2% PrL)
2,000 ppm
2,500—5,000 ppm
qua t
412,000—628,000 ppm
(0.2% PrL)
( Household )
Disinfection of surfaces.
Formulated with isopropanol, alkyl*dlmethyl benzyl
aminonium chloride *alkyl (60% Cl4, 30% C16, 5% C12,
5% C18), alkyl*dimethyl ethylbenzyl aminonium chlo-
ride *alkyl (50% C12, 30% Cl4, 17% C16, 3% C18),
and bis(tributyltin)oxide.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and alkyl*dimethyl
benzyl aminonium chloride *alkyl (50% C14, 40% Cl2,
10% Cl6).
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and methyldodecyl—
benzyl trimethyl anunonium chloride 80% and methyl—
dodecylxylylene bi.s(trimethyl ammonium chloride)
20%.
/63000 0A
Household Premises and
Equipment
Issued: 3—11—85
General Instructions for Use : The products regis-
tered in this site are for use in household prem-
ises (i.e. walls, floors, fixtures) and contents
(i.e. furnishings, equipment, and other hard sur-
faces).
Preclean surfaces prior to treatment when required.
Dilute products as specified on labels. Apply by
mop, wipe, scrub, or spray.
For mold/mildew control, preclean hard non—porous
surfaces prior to treatment when required. Apply
by sponge, cloth, mop, or spray. Allow to dry.
Do not rinse. Repeat periodically or when mold!
mildew growth appears.
V.1—077402—4
A18
Al 9
A2 2
A2 4
A2 5
A2 9
FYABQ BB
29
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EPA Index to Pesticide Chemicals
Site, Efficacy,
Dosage and Formulation
Use Directions
A2 4
Household Premises and Equipment (continued)
Bac terios tat
76—227 ppm
(0.25% SC/L)
or
500 ppm
(0.05% RTU)
Bacteriostatic treatment for surfaces.
Pseudomonac ide
Tuberculoc ide
Disinfectant
Deodorizer
Virucide—effective against Influenza Type A2 virus
Fungicide
Mold / m 11 dew
76—227 ppm
(0.25% SC/L)
14 ppm
3,400 ppm quat
421,000 ppm
(0.0014% PrL)
134 ppm
1,000 ppm quat
450,000 ppm
(0.0134% PrL)
200 ppm
3,800 ppm
(0.02% PrL)
500 ppm
1,500 ppm
(0.05% PrL)
2,000 ppm
2,500—5,000 ppm
quat
445,000—629,000
(0.2% PrL)
Issued: 3—11—85
Disinfection and mold/mildew control on surfaces.
Disinfection of surfaces.
Formulated with isopropanol, alkyl*dimethyl benzyl
ammonium chloride *alkyl (60% C14, 30% Cl6, 5% Cl2,
5% Cl8), alkyl*dimethyl ethylbenzyl ammonium chlo-
ride *alky]. (50% Cl2, 30% C14, 17% C16, 3% C18),
and bis(tributyltin)oxide.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol, alkyl*dimethyl ben—
zyl ammonium chloride *alkyl (60% C14, 30% Cl6, 5%
Cl2, 5% C18), alkyl*dimethyl ethylbenzyl ammonium
chloride *alkyl (68% C12, 32% Cl4), and triethylene
glycol.
Disinfection and mold/mildew control on surfaces.
Formulated with o—phenylphenol, 4—chloro—2—cyclo—
pentyiphenol, and lauryl diethanolamide.
Disinfection and mold/mildew control on surfaces.
Formulated with o—phenylphenol.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and alkyl*dimethyl
benzyl ammonium chloride *alkyl (50% C14, 40% C12,
ppm 10% C16).
V.1—077402—5
Al 8
A19
A2 2
A24
A2 5
A2 9
FYABQBB
30
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
Household Premises and Equipment (continued)
2,000 ppm Disinfection and mold/mildew control on surfaces.
2,500—5,000 ppm Formulated with ethyl alcohol and methyldodecyl—
quat benzyl trimethyl anuilonium chloride 80% and methyl—
445,000—629,000 ppm dodecyixylylene bls(trimethyl ammonium chloride)
(0.2% PrL) 20%.
JÔ30090A Sickroom Premises and
Contents
General Instructions for Use : The products regis-
tered in this site are for use in sickrooms found
in places other than primary health care facili-
ties. This includes household, commercial, insti-
tutional, and industrial establishments. The
products may be used on premises (i.e. ceilings,
fixtures, floors, walls, woodwork); contents (i.e.
bedding, furniture, telephones); equipment (i.e.
basins, bedpans, receptacles, vomitus pails, pans);
and utensils (i.e. dishes, trays, eating utensils,
glassware).
Thoroughly preclean and rinse surfaces prior to
treatment. One—step cleaner—sanitizer 5 and
cleaner—disjnfectants may be used without prior
cleaning. Dilute product as directed. Application
is by wet wipe, scrub, flood, flush, rinse, or
spray methods. Observe required contact time.
Rinse where required.
For mold/mildew control, preclean hard non—porous
surfaces prior to treatment when required. Apply
by sponge, cloth, mop, or spray. Allow to dry.
Do not rinse. Repeat periodically or when mold/
mildew growth appears.
The use of sanitizing solutions other than those
identified in Title 21 Code of Federal Regulations,
Section 178.1010; disinfecting solutions; one—step
cleaner—sanjtizers or one—step cleaner—disinfec...
tants must always be followed by a potable water
rinse when applied to any food contact surfaces.
Issued: 3—11—85 V.1—077402—6
31
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L’A Index to Pesticide Chemicals
Site, Efficacy , ____________________
Dosage and Formulation
Sickroom Premises and Contents (continued)
Use Directions
Ps eudomonac ide
Tuberculoc ide
Disinfectant
Deodorizer
Virucide—effective against Influenza Type AZ virus
Fungic ide
Mold/mildew
14 ppm
3,400 ppm quat
421,000 ppm
(0.0014% PrL)
2,000 ppm
2,500—5,000 ppm
qua t
445,000—629,000
(0.2% PrL)
2,000 ppm
2,500—5,000
ppm
qua t
4 12,000—628,000
(0.2% PrL)
3,600 ppm
550,000 ppm
(0.36% PrL)
Disinfection of surfaces.
Formulated with isopropanol, alkyl*dimethyl benzyl
ammonium chloride *alkyl (60% C14, 30% C16, 5% C12,
5% C18), alkyl*dimethyl ethylbenzyl ammonium chlo-
ride *aLkyl (50% C12, 30% C14, 17% Cl6, 3% Cl8),
and bis(tributyltin)oxide.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and alkyl*di.methyl.
benzyl ammonlum chloride *alkyl (50% C14, 40% Cl2,
ppm 10% C16).
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and methyldodecyl—
benzyl trimethyl ammonium chloride 80% and methyl—
ppm dodecylxylylene bis(trimethyl ammonium chloride)
20%.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol, o—phenylphenol, and
4—chloro—2—cyc lopentylphenol.
( Commercial and Industrial Uses )
/770020A—l Athletic and Recrea-
tional Equipment
Issued: 3—11—85
General Instructions for Use : The product regis-
tered in this site is for use on athletic and
recreational equipment surfaces.
Product label may recommend precleaning of surface
prior to treatment. Apply product by spray, cloth,
mop, sponge, brush, or pump spray. Thoroughly wet
surfaces and allow for required contact period.
V.1—077402—i
A18
Al 9
A22
A2 4
A2 5
A2 9
FYABQBB
32
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
Athletic and Recreational Equipment (continued)
A18 Pseudomonacide
A22 Disinfectant
A.24 Deodorizer
14 ppm Disinfection of surfaces.
3,400 ppm quat Formulated with isopropanol, alkyl*dimethyl benzyl
421,000 ppm ammonium chloride *alkyl (60% Cl4, 30% C16, 5% C12,
(0.0014% PrL) 5% C18), alkyl*dimethyl ethylbenzyl ammonium chlo-
ride *alkyl (50% C12, 30% C14, 17% Cl6, 3% C18),
and bis(tributyltin)oxide.
/770000A Commercial, Industrial
and Institutional
Premises and Equipment
( Non—Medical)
General Instructions for Use : The products regis-
tered in this site are for use on commercial, in-
dustrial, institutional, and public premises and
equipment.
This site includes the premises and equipment of
the following areas:
1) Commercial — hotels, motels, theaters, office
buildings, airports, bus stations, and train ter-
minals.
2) Industrial — factories, mills, industrial plants
and areas.
3) Institutional — schools, colleges, camps, cor-
ridors, offices, auditoriums, institutions, and
asylums.
4) Public areas — public areas, public buildings,
or public rooms.
Premises is defined to include: ceilings, doors,
doorknobs, fixtures, floors, light switches,
stairs, walls, windows, and woodwork.
Remove heavy surface soil or preclean surfaces
prior to treatment as indicated by label instruc-
tions. One step cleaner—sanicizers and cleaner—
disinfectants may be used without prior cleaning
of lightly or moderately soiled surfaces. Dilute
product according to label directions. Apply
product by mop, scrub, sponge, spray, or automatic
machine process. Wet surfaces thoroughly. Allow
recommended contact time. Drain surface or rinse
with potable water where required.
For mold/mildew control, preclean hard non—porous
surfaces prior to treatment when required. Apply
by sponge, cloth, mop, or spray. Allow to dry.
Issued: 3—11—85 V.1—077402—8
33
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
Commercial, Industrial and Institutional Premises and Equipment (Non—
Medical ) (continued)
Do not rinse. Repeat periodically or when rnold/
mildew growth appears.
A24 Bacteriostat
348 ppm
521 ppm
(37. SC/L)
500 ppm
(0.05% RTU)
A18 Pseudomonacide
A19 Tuberculocide
A22 Disinfectant
A24 Deodorizer
A25 Virucide—effective
A29 Fungicide
FYABQBB Mold/mildew
3—9 ppm
905—2,630 ppm
(0.02% SC/L)
26—59 ppm
400—882 ppm quac
27—59 ppm
(0.17. SC/L)
155—458 ppm
2,210—6,540 ppm
(2% SC/L)
14 ppm
3,400 ppm quat
421,000 ppm
(0.0014% PrL)
Bacteriostatjc treatment for surfaces.
Formulated with lauryl diethanolamide and N—lauryl
diethylenetriamine.
Bacteriostatic treatment for surfaces.
against Influenza Type A2 virus
Disinfection and cleaning of surfaces.
Formulated with o—benzyl—p—chlorophenol; p—tert—
amyiphenol; and o—phenylphenol, sodium salt.
Disinfection of surfaces.
Formulated with alkyl*dimethyl benzyl ammonium
chloride *alkyl (607. C14, 307. C16, 57. C12, 5% Cl8),
alkyl*dimethyl ethylbenzyl ammonium chloride *alkyl
(50% Cl2, 30% C14, 177. C16, 3% C18), and N—alkyl*_
N—ethyl morpholinium ethyl sulfate *alkyl (92% C18,
87. Cl6).
Disinfection and cleaning of surfaces.
Formulated with o—benzyl—p—chlorophenol, p—tert—
amyiphenol, o—phenylphenol, propylene glycol,
potassium hydroxide, and potassium ricinoleate.
Disinfection of surfaces.
Formulated with isopropanol, alkyl*dimethyl benzyl
ammonium chloride *alkyl (60% Cl4, 30% C16, 5% Cl2,
5% C18), alkyl*dimethyl ethylbenzyl aminonium chlo-
ride *alkyl (50% C12, 30% C14, 17% Cl6, 37. Cl8),
and bis(tributyltin)oxtde.
V.1—077402—9
Issued: 3—11—85
34
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EPA Index to Pesticide Chemicals
Site, Efficacy,
Dosage and Formulation
Use Directions
Commercial, Industrial and Institutional Premises and Equipment (Non—
Medical ) (continued)
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol, alkyl*dimethyl ben—
zyl ammonium chloride *alkyl (60% C14, 30¼ C16, 5%
C12, 5% C18), alkyl*dimethyl ethylbenzyl aminonium
chloride *alkyl (68% C12, 32% C14), and triethylene
glycol.
/700000A Commercial Transporta-
tion Vehicles
26—59 ppm
400—882 ppm quat
27—59 ppm
(0.1% SC/L)
Issued: 3—11—85
General Instructions for Use : The products regis-
tered in this site are for use on commercial
transportation vehicle surfaces. This includes
buses, railroad cars, steamships, automobiles,
airplanes, boats, and other conveyances.
E’reclean surfaces of vehicle or conveyance.
Dilute product as recommended on label. Apply
solution by mop, swab, rag, cloth, or spray.
Allow required contact time. Rinse treated
surfaces or allow to air dry in accordance with
label instructions.
For mold/mildew control, preclean hard non—porous
surfaces prior to treatment when required. AppLy
by sponge, cloth, mop, or spray. Allow to dry.
Do not rinse. Repeat periodically or when mold/
mildew growth appears.
Disinfection of surfaces.
Formulated with alkyl*dimethyl benzyl ammonium
chloride *alkyl (60% Cl4, 30¼ C16, 5% C12, 5% C18),
alkyl*dimethyl ethylbenzyl ammonium chloride *alkyl
(50% C12, 30% C14, 17% C16, 3% C18), and N_alkyl*_
N—ethyl morpholinium ethyl sulfate *alkyl (92% C18,
8% Cl6).
V.1—077402—10
134 ppm
1,000 ppm quat
450,000 ppm
(0.0134% PrL)
3,600 ppm
550,000 ppm
(0.36% PrL)
7,000 ppm
553,000 ppm
(0.7% PrL)
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol, o—phenylphenol, and
4—chloro—2—cyc lopentyiphenol.
Disinfection and moldJmildew control on surfaces.
Formulated with ethyl alcohol, o—phenylphenol, and
N—lauryl diethylenetriamine.
A18
A2 2
A2 4
A2 9
F YABQ B B
Pseudomonac ide
Disinfectant
Deodorizer
Fungicide
Mold/mildew
35
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
Commercial Transportation Vehicles (continued)
500 ppm Disinfection and mold/mildew control on surfaces.
1,500 ppm Formulated with o—phenylphenol.
(0.05 PrL)
( Food and Feed Processing Plants)
General Information:
Equipment and food contact surfaces general instructions for use :
Thoroughly clean and rinse equipment. Sanitize immediately before
equipment is to be used, or as specified by local regulations. One—step
sanitizer—cleaners and disinfectant—cleaners may be used without prior
cleaning. Dilute product as directed. Application may be by wet wipe,
scrub, flood, flush, rinse, circulation, immersion, or spray methods.
Observe local regulations regarding contact period of the sanitizing
solution. A 2 minute contact time is stipulated by health departments
that follow the United States Public Health Service Ordinance and Code.
Adhere to manufacturer’s instructionsregarding the temperature of dilu—
ent and rinse. Drain equipment and food contact surfaces thoroughly.
Rinse with potable water when required.
Sanitizing solutions are regulated by the Food and Drug Administration
as Indirect Food Additives under Title 21, Code of Federal Regulations,
Section 178.1010. Solutions specified in this sect ion may be safely
used on food processing equipment within the prescribed conditions. The
solutions may not exceed specified concentrations. A potable water rinse
is not required following the use of the solutions, provided the equip-
ment and surfaces are adequately drained before contact with food. The
solutions may not exceed specified concentrations. A potable water rinse
is required when drainage alone is inadequate to prevent adulteration of
food products.
rhe use of sanitizing solutions other than those identified in Title 21
code of Federal Regulations, Section 178.1010, disinfecting solutions,
one—step sanitizer—cleaners and disinfectant—cleaners must always be
followed by a potable water rinse.
Premises (i.e. floors, walls, and other non—food contact surfaces) gen-
eral instructions for use : Product directions may require a precleaning
step before treatment. Remove all particulate contamination. Applica-
tion may be by wipe, scrub, rinse, mop, or spray. Allow recommended
contact time. Remove or carefully protect food products and food pack-
aging materials before using quaternary ammonium products. Avoid con-
tamination of food contact surfaces and food when applying pesticide
solutions. Drain surfaces thoroughly. Rinse with potable water where
required.
For mold/mildew control, preclean hard non—porous surfaces prior to
treatment when required. Apply by sponge, cloth, mop, or spray. Allow
Issued: 3—11—85 V.1—077402—il
36
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EPA Index to Pesticide Chemicals
Site, Efficacy,
Dosage and Formulation
Use Directions
General Information (continued)
to dry. Do not rinse. Repeat periodically or when mold/mildew growth
appears.
General Instructions for Use : The product regis-
tered in this site is for use on food processing
equipment (i.e. blanchers, evaporators, fillers,
tanks, vats, pipelines, valves, utensils, cutting
boards, and other food contact surfaces).
Disinfection of surfaces.
Formulated with alkyl*dimethyl benzyl ammoniurn
chloride *alkyl (60% C14, 30% Cl6, 5% C12, 5% C18),
alkyl*dimethyl ethylbenzyl ammonium chloride *alkyl
(50% C12, 30% C14, 17% Cl6, 3% C18), and N—alkyl*_
N—ethyl rnorpholinium ethyl sulfate *alkyl (92% Cl8,
8% C16).
General Instructions for Use : The products regis-
tered in this site are for use on food processing
plant premises (i.e. floors, walls, and other non—
food contact surfaces).
Pseudomonac ide
Tuberculocide
Disinfectant
Deodorizer
Virucide—effective against Influenza Type A2 virus
Fungicide
Mold/mildew
26—59 ppm
400—882 ppm quat
27—59 ppm
(0.1% SC/L)
3,600 ppm
550,000 ppm
(0.36% PrL)
Issued: 3—11—85
Disinfection of surfaces.
Formulated with alkyl*dimethyl benzyl aminonium
chloride *alkyl (60% C14, 307. C 16, 5 Cl2, 57. Cl8),
alkyl*dimethyl ethylbenzyl ammontum chloride *alkyl
(50% C12, 30% C14, 17% C16, 37. C18), and N—alkyl*_
N—ethyl inorpholinium ethyl sulfate *alkyl (92% C18,
87. C16).
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol, o—phenylphenol, and
4—chloro—2—cyc lopentylphenol.
V.1—077402—12
/7I000JE Food Processing Equip-
ment and Surfaces
A22 Disinfectant
A24 Deodorizer
A29 Fungicide
26—59 ppm
400—882 ppm quat
27—59 ppm
(0.1% SC/L)
/7I000JF Food Processing Plant
Premises
A18
Al9
A2 2
A2 4
A2 5
A2 9
FYABQBB
37
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EPA Index to Pesticide Chemicals
Site, Efficacy , Use Directions
Dosage and Formulation
( Eating Establishments )
/72006JE Eating Establishment
Equipment and Utensils
General Instructions for Use : The products regis-
tered in this site are for use on equipment and
utensils in eating establishments (i.e. restau-
rants, taverns, bars, cafeterias, etc.) where food
and beverages are served. Utensils include sil-
verware, dishes, glassware, and similiar cooking
and eating utensils. Equipment includes fixtures,
stoves, sinks, and refrigerators.
For the treatment of utensils :
1) Remove surface soils by scraping or flushing
with water.
2) Wash with a suitable detergent or cleaner.
3) Rinse with clean water.
4) Sanitize in solution of product. Immerse all
utensils in sanitizing solution for at least 2
minutes, or for contact period specified by gov-
erning sanitary code.
5) Rinse with potable water if required.
6) Drain and allow to air dry. Do not use a towel
to dry.
For the treatment of equipment :
1) Clean all equipment prior to treatment with
product. One—step cleaner—sanitizers and cleaner—
disinfectants do not require a precleaning step.
2) Dilute products according to label directions.
3) Apply by mop, sponge, wipe, or spray.
4) Products may require a rinse with potable water
prior to equipment reuse.
5) Products may recommend treated surfaces be al-
lowed to air dry.
One—step cleaner—sanitizers and cleaner—disinfec—
tants may be used without prior cleaning.
Observe local regulations regarding contact period
of the sanitizing solution. A minimum of 2 minutes
contact time is stipulated by health departments
that follow the United States Public Health Service
Ordinance and Code. Adhere to manufacturer’s in-
structions regarding the temperature of diluent and
rinse. Drain equipment and food contact surfaces
thoroughly. Rinse with potable water when requir-
ed.
Issued: 3—11—85 V.1—077402—13
38
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EPA Index to Pesticide Chemicals
Site, Efficacy,
Dosage and Formulation
Use Directions
Eating Establishment Equipment and Utensils (continued)
SanitLzing solutions are regulated by the Food and
Drug Administration as Indirect Food Additives un-
der Title 21, Code of Federal Regulations, Section
178.1010. Solutions specified in this section may
be safely used on food processing equipment within
the prescribed conditions. The solutions may not
exceed specified concentrations. A potable water
rinse is required when drainage alone is inadequate
to prevent adulteration of food products.
The use of sanitizing solutions other than those
identified in Title 21, Code of Federal Regula-
tions, Section 178.1010; disinfecting solutions;
one—step cleaner—sanitizers and cleaner—disinfec—
tants must always be followed by a potable water
rinse.
For mold/mildew control, preclean hard non—porous
surfaces prior to treatment when required. Apply
by sponge, cloth, mop, or spray. Allow to dry.
Do not rinse. Repeat periodically or when moLdf
mildew growth appears.
Pseudornonac ide
Tubercu locjde
Disinfectant
Deodorizer
Virucide—effective against Influenza Type A2 virus
Fungic ide
Mold/mildew
200 ppm
3,800 ppm
(0.02% PrL)
2,000 ppm
2,500—5,000 ppm
quat
445,000—629,000
(0.2% PrL)
2,000 ppm
2,500—5,000 ppm
qua t
412,000—555,000
(0.2% PrL)
Issued: 3—11—85
Disinfection and mold/mildew control on surfaces
Formulated with o—phenylphenol, 4 -chloro—2—cyclo—
pentyipheno]., and lauryl diethanolamide.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and alkyl*dimethyl
benzyl amrnonium chloride *alkyl (507. C14, 40% Cl2,
ppm 10% Clô).
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and methyldodecyl—
benzyl trimethyl arnxnonium chloride 80% and methyl—
ppm dodecylxyly] .ene bis(trimethyl arnmonlum chloride)
20%.
V.1—077402—14
Al8
A19
A2 2
A24
A2 S
A2 9
FYABQ B8
39
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EPA Index to Pesticide Chemicals
Site, Efficacy,
Dosage and Formulation
Use Directions
/72000JF Eating Establishment
Premises
A24
Bac teriostat
General Instructions for Use: The products regis-
tered in this site are for use on eating estab-
lishment premises (i.e. floors, walls, and other
non—food contact surfaces). Eating establishment
premises include commercial restaurants and
cafeterias, institutional and household kitchens
and dining areas, etc.
Preclean surfaces before treatment with the anti-
microbial solution. One—step cleaner—sanitizers
and cleaner—disinfectants do not require a pre—
cleaning step. Dilute product according to label
directions. Apply by mop, spray, cloth, sprinkle,
scrub, brush, or machine apparatus. Thoroughly
wet surfaces to be treated. Avoid contamination
of foods or food contact surfaces. Some products
require a rinse with potable water following the
antimicrobial treatment.
For mold/mildew control, preclean hard non—porous
surfaces prior to treatment when required. Apply
by sponge, cloth, mop, or spray. Allow to dry.
Do not rinse. Repeat periodically or when mold!
mildew growth appears.
348 ppm
521 ppm
(37. SC/L)
Bacteriostatic treatment for surfaces.
Formulated with lauryl diethanolamide and N—lauryl
diethylenetriamine.
Pseudomonac ide
Tuberculocide
Disinfectant
Deodor izer
Virucide—effective against Influenza Type A2 virus
Fungic ide
Mold / mildew
3—9 ppm
905—2,630 ppm
(0.02% SC/L)
26—59 ppm
400—882 ppm quat
27—59 ppm
(0.1% SC/L)
Issued: 3—11—85
Disinfection and cleaning of surfaces.
Formulated with o—benzyl—p—chlorophenol; p—tert—
amylphenol, and o—phenylphenol, sodium salt.
Disinfection of surfaces.
Formulated with alkyl dimethy1 benzyl ammonium
chloride *alkyl (60% C14, 30% C16, 5% Cl2, 57. Cl8),
alkyl*dimethyl ethylbenzyl ammonium chloride *alkyl
(50% C12, 30% C14, 17% C16, 3% C18), and N_alkyl*_
N—ethyl morpholinium ethyl sulfate alkyl (92% Cl8,
8% C16).
V.1—077402—15
Al8
A 19
A2 2
A24
A2 5
A2 9
FYABQBB
40
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EPA Index to Pesticide Chemicals
SLte, Efficacy 1
Dosage and Formulation
Use Directions
Eating Establishment Premises (continued)
155—458 ppm
2,210—6,540 ppm
(2% SC/L)
14 ppm
3,400 ppm quat
421,000 ppm
(0.0014% PrL)
2,000 ppm
5,000 ppm quat
629,000 ppm
(0.2% PrL)
2,000 ppm
2,500—5,000 ppm
quat
412,000—628,000
(0.2% PrL)
( Food Markets )
Disinfection and cleaning of surfaces.
Formulated with o-benzyl—p—chlorophenol, p—tert—
amyiphenol, o—phenylphenol, propylene glycol,
potassium hydroxide, and potassium ricinoleate.
Disinfection of surfaces.
Formulated with isopropanol, alkyl*dimethyl benzyl
ammonium chloride *alkyl (60% C14, 30% C16, 5% C12,
5% Cl8), alkyl*dimethyl ethylbenzyl ammonium chlo-
ride *alkyl (50% Cl2, 30% C14, 17% C16, 3% C18),
and bis(tributyltin)oxide.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and alkyl*dimethyl
benzyl ammonium chloride *alkyi (50% C14, 40% C12,
10% C16).
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and methyldodecyl—
ben yl trimethyl ammonium chloride 80% and methyl—
ppm dodecylxylylene bis(trimethyl ammonium chloride)
20%.
/730020A Food Market Premises
Issued: 3—11—85
General Instructions for Use : The product regis-
tered in this site is for use on food market or
food store premises (i.e. walls, floors, and other
non—food contact surfaces).
A precleaning step before treatment is recommended
if surfaces are heavily soiled. Dilute product as
recommended. Application is by mop, spray, sponge,
or machine. Do not permit product to come in con-
tact with food. If food contact surfaces are con-
tacted by product solution, rinse surfaces with
potable water prior to reuse.
For mold/mildew control, preclean hard non—porous
surfaces prior to treatment when required. Apply
by sponge, cloth, mop, or spray. Allow to dry.
Do not rinse. Repeat periodically or when mold!
mildew growth appears.
V.1—077402—16
41
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
Food Market Premises (continued)
Al8 Pseudomonacide
A19 Tuberculocide
A22 Disinfectant
A24 Deodorizer
A25 Virucide—effective against Influenza Type A2 virus
FYABQBB Mold/mildew
3,600 ppm Disinfection and mold/mildew control on surfaces.
550,000 ppm Formulated with ethyl alcohol, o—phenylphenol, and
(0.36% PrL) 4—chloro—2—cyclopentylphenol.
( Hospital and Related Institutions )
/74012GA—2 Hospital Critical
Equipment
General Instructions for Use : The product regis-
tered in this site is for use on hospital equip-
ment that requires more stringent anitmicrobial
treatment than general hospital equipment. This
includes equipment which contacts the blood, tis-
sue, or mucous membranes of the patient or equip-
ment which is used in operating rooms, isolation
wards, nurseries, and other critical hospital
areas. Lensed instruments and fiberoptics, anes-
thesia and respiratory therapy equipment, and
hemodi.alysis machines are in this site.
Disassemble items as much as possible. Remove all
visible soil before treatment with a disinfectant.
Before treatment with a one—step disinfectant—
cleaner remove heavy soil; during treatment remove
other visible soil.
For an antimicrobial to be effective all surfaces
of the item must come in contact with the chemical
for the required contact time. All surfaces must
be rinsed with water when recommended. In the
case of narrow tubing or catheters this may require
flushing with a needle and syringe.
Site Specific General Warnings : If possible,
critical equipment should be sterilized with heat
or ethylene oxide. Phenolics and quaternary ammo—
nium compound solutions do not destroy bacterial
spores, hepatitis or hydrophi.lic viruses. Quater—
nary aminonium compounds also do not destroy
Mycobacterium tuberculosis .
Issued: 3—11—85 V.1—077402—Li
42
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
Hospital Critical Equipment (continued)
For mold/mildew control, preclean hard non—porous
surfaces prior to treatment when required. Apply
by sponge, cloth, mop, or spray. Allow to dry.
Do not rinse. Repeat periodically or when mold/
mildew growth appears.
A19 Tuberculocide
A22 Disinfectant
A24 Deodorizer
FYABQBB Mold/mildew
476 ppm Disinfection and mold/mildew control on surfaces.
769 ppm Formulated with o—benzyl—p—chloropheno l, potassium
(3.1% SC/L) salt.
/740000A Hospital Premises and
Equipment
General Instructions for Use : The products regis-
tered in this site are for use in hospitals and
medical facility premises (i.e. floors, walls,
ceilings, fixtures, air ducts, and environmental
surfaces) and on hospital non—critical contents
(i.e. furniture, bedframes, telephones, tables,
carts, physical therapy equipment, bedpans, basins,
and janitorial equipment). Some products are in-
tended for use on hospital conductive floors.
Medical facilities include nursing homes, doctor
and dentist offices, laboratories, and sanitariums.
Hospital noncritical contents includes those items,
hard surfaces, equipment, and furniture that do not
contact the patient or only contact the patient’s
skin.
Surfaces must be precleaned with detergent and
rinsed with water before treatment with a disin-
fectant solution. One—step disinfectant—cleaners
will clean and disinfect in 1 step in the pres-
ence of light to moderate soil conditions, heavy
surface soil must be removed before treatment.
Dilute products according to label directions and
apply.
Methods of Application:
Flood application . Cover surface with solution.
Allow required contact time. An automatic scrubber
may be used to loosen soil. Remove solution with
wet vacuum pick—up.
Issued: 3—11—85 V.1—077402—18
43
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
Hospital Premises and Equipment (continued)
Mop, sponge, or cloth application . Dip applicator
in pail of solution and apply to surface. A double
bucket method is preferred for one—step cleaning
and disinfecting. The applicator is dipped in a
rinse bucket of the solution to flush Out soil be-
fore being returned to wash bucket.
Spray application . Product is 1) in pressurized
spray container or 2) solution is to be applied by
hand—trigger spray dispenser. Spray with product
from a distance of 6 to 8 inches until surface is
moist. For one—step cleaning—disinfecting, wipe
surface clean with sponge or cloth.
Fog application . Close all doors and windows and
remove humans and animals from room. Apply product
with electric sprayer or mechanical fogging equip-
ment. Refer to product directions for rate, dura-
tion, and frequency of spraying, and required in-
terval before re—entering room. Fogging is an
adjunct to standard cleaning and disinfecting.
Following fogging, clean and disinfect surfaces
manually.
After cleaning or rinsing hospital floors, soil
containing solutions must be removed (i.e. by wet
vacuum pick—up). Following disinfectant treatment,
a rinse with water is usually not required. Dried
residue of disinfectant on conductive flooring
(i.e. in operating rooms) must not interfere with
floor conductivity if a flammable anesthetic will
be used in the room. Products which meet this
requirement are in accordance with the National
Fire Protection Association (N.F.P.A) Standard 56A
and are registered for use on conductive flooring.
For mold/mildew control, preclean hard non—porous
surfaces prior to treatment when required. Apply
by sponge, cloth, mop, or spray. Allow to dry.
Do not rinse. Repeat periodically or when mold/
mildew growth appears.
A24 Bacteriostat
500 ppm Bacteriostatic treatment for surfaces.
(0.05% R’flJ)
Issued: 3—11—35 V.1—077402—19
44
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EPA Index to PesticLde Chemicals
Site, Efficacy,
Dosage and Formulation
Use Directions
Hospital Premise8 and Equipment (continued)
Pseudomonac ide
Tuberc u bc ide
Disinfectant
Deodorizer
Virucide—effectjve against Influenza Type A2, Herpes simplex and Vaccinia
viruses
A29 Fungicide
FYABQBB Mold/mildew
3—9 ppm
905—2,630 ppm
(0.02% SCIL)
26—59 ppm
400—882 ppm quat
27—59 ppm
(0.1% SC/L)
155—458 ppm
2,210—6,540 ppm
(2% SC/L)
476 ppm
769 ppm
(3.1% SC/L)
14 ppm
3,400 ppm quat
421,000 ppm
(0.0014% PrL)
134 ppm
1,000 ppm quat
450,000 ppm
(0.0134% PrL)
240 ppm
786,000 ppm
(0.024% PrL)
Issued: 3—11—85
Disinfection and cleaning of surfaces.
Formulated with o—benzyl—p—chborophenol; p—tert—
amylphenol; and o—phenylphenol, sodium salt.
Disinfection of surfaces.
Formulated with alkyl*d imethyl benzyl ammonlum
chloride *alky]. (60% C14, 30% C16, 5% C12, 5% C18),
a1ky1 dimethyl ethylbenzyl ammonium chloride *alkyl
(50% Cl2, 30% C14, 17% C16, 3% C18), and N—alkyl*_
N—ethyl morpholinium ethyl sulfate *alkyl (92% C18,
8% Cl6).
Disinfection and cleaning of surfaces.
Formulated with o—benzyl—p—ciloropheno l, p—tert—
amylphenol, o—phenylphenol, propylene glycol,
potassium hydroxide, and potassium ricinoleate.
Disinfection and mold/mildew control on surfaces.
Formulated with o—benzyl—p—chlorophenol, potassium
salt.
Disinfection of surfaces.
Formulated with isopropanol, alkyl*dimethyl benzyl
arnmonium chloride *alkyl (60% Cl4, 30% C16, 5% C12,
5% C18), alkyl*dimethyl ethylbenzyl ammonium chlo-
ride ‘ alky1 (50% C12, 30% C14, 17% Cl6, 3% C18),
and bls(tributyltin)oxide.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol, alkyl*dimethyl ben—
zyl ammonium chloride *alkyl (60% C14, 30% Cl6, 5%
Cl2, 5% C18), alkyl*dimethyl ethylbenzyl aminonium
chloride *alky]. (68% Cl2, 32% C 14), and triethylene
glycol.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and o—phenylphenol.
V.1—077402—20
A18
Al9
A2 2
A2 4
A2 5
45
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EPA lnde to Pesticide Chemicals
Site, Efficacy,
Dosage and Formulation
Use Directions
Hospital Premises and Equipment (continued)
2,000 ppm
5,000 ppm quat
629,000 ppm
(0.2% PrL)
2,000 ppm
2,500—5,000 ppm
quat
412,000—628,000
(0.2% PrL)
3,600 ppm
550,000 ppm
(0.36% PrL)
10,000 ppm
280,000 ppm
(1% PrL)
/74011GA—2 Surgical Instruments
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and alkyl*dimethyl
benzyl ammonium chloride *alkyl (50% C14, 40% Cl2,
10% C16).
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and methyldodecyl—
benzyl trimethyl ammonium chloride 80% and methyl—
ppm dodecyixylylene bis(trimethyl aminonium chloride)
20%.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol, o—phenylphenol, and
4—chloro—2—cyc lopentylphenol.
Disinfection and mold/mildew control on surfaces.
Formulated with isopropanol.
General Instructions for Use : The product regis-
tered in this site is for use on surgical instru-
ments and hospital, medical, and/or laboratory
critical instruments. Criti a1 instruments are
those instruments which penetrate the tissue or
make intimate contact with ene blood or the mucous
membranes of the body.
Instrument surfaces must be precleaned with soap
or detergent and rinsed with water before treatment
with art antimicrobial solution. Instruments should
be scrubbed free of organic debris and allowed to
drain dry. One—step disinfectant—cleaners will
clean and disinfect in one step only in the pres-
ence of light to moderate soil conditions; heavy
surface soil must be removed before treatment with
a one—step disinfectant—cleaner.
Methods of Application :
Instrument presoak . Lightly to moderately soiled
instruments are immersed in disinfectant—cleaner
solution immediately after use and before cleaning
and terminal disinfection.
Wipe treatment . Instrument surfaces are sprayed
until wet.
Issued: 3—11—85
V.1—077402—21
46
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
Surgical Instruments (continued)
Solution immersion . Product is a ready—to—use so-
lution or a concentrate which is diluted with water
according to label instructions. The instruments
are immersed in the solution; if the product is a
disinfectant—cleaner, the instruments must be rub-
bed or brushed free of soil. To disinfect or
sterilize all surfaces, the instrument must make
contact with the solution, being careful to avoid
entrapment of air bubbles. Required contact time
and rinse directions must be observed, If no con-
tact time is given, allow a minimum of 10 minutes.
Sodium nitrite should be added to inhibit rust when
recommended.
Site Specific General Warnings : If possible, cri-
tical instruments should be sterilized with heat
or ethylene oxide. Phenolics and quaternary am—
monium compound solutions do not destroy bacterial
spores, hepatitis or hydrophilic viruses. Quater—
nary ammonium compounds also do not destroy Myco—
bacterium tuberculosis .
For mold/mildew control, preclean hard non—porous
surfaces prior to treatment when required. Apply
by sponge, cloth, mop, or spray. Allow to dry.
Do not rinse. Repeat periodically or when mold/
mildew growth appears.
Al9 Tuberculocide
A22 Disinfectant
A24 Deodorizer
FYABQBB Mold/mildew
476 ppm Disinfection and mold/mildew control on instru—
769 ppm ments.
(3.1% SC/L) Formulated with o—benzyl—p—chlorophenol, potassium
salt.
Issued: 3—11—85 V.1—077402—22
47
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PA Index to Pesticide Chemicals
Site, Efficacy,
Dosage and Formulation
Use Directions
( Industrial Preservatives and Additives )
/810120A Latex and Resin Emul —
s ions
A24
Bacteriostat
General Instructions for Use : The products regis-
tered in this site are used to control the growth
of bacteria and fungi in latex and resin emulsions
during manufacture and storage. These chemical
products are for industrial use only.
Add product to the latex or resin emulsion at a
point during the manufacturing process where there
is sufficient time and agitation for good disper-
sion.
158 ppm
40 ppm
(79% sC/S)
1,980 ppm
(99% sC/S)
Bacteriostatic treatment for PVA latex emulsions.
Add 0.02 percent of product based on the weight of
the emulsion.
Formula ed with zinc 2—pyridinethiol 1—oxide.
Bacteriostatic treatment for resin emulsions. Add
0.2 percent of product based on the weight of the
res in.
/810050A Leather and Leather
Products
General Instructions for Use :
tered in this site is for use
leather products. It is used
of protein digesting bacteria
transit from soaking plant to
plant) on rawhide.
The product regis—
on leather and
to control the growth
(during short term
tannery or curing
This product is for industrial use only, and is to
be added to various steps in leather processing
according to the following methods of application:
Fresh—hide spray method . Spray product on the
hair side of washed and fleshed hides. Trimmings
for animal feed should be removed from the hides
prior to application. Fresh treated hides should
not be exposed for more than 3 days before further
processing.
Soak method . Add product to the solutions used in
paddle, drum, and vat soaking. Use as a precaution
against bacterial action. Agitate 20 to 30 min-
utes.
Issued: 3—11—85
V.1—077402—23
48
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
Leather and Leather Products (continued)
A24 Bacterjostat
250—2,500 ppm Bacterjostatjc treatment for leather. Add 0.25
1,950—19,500 ppm percent to 2.5 percent of product based on the
(10% RTU) weight of the leather.
Formulated with isopropanol.
/810090A Paints
General Instructions for Use : The product regis-
tered in this site is a bacteriostat and fungistat
used to control bacteria and fungi in paints during
manufacture and in—can storage. This product is a
preservative for in—can storage and is not consid-
ered to be effective in protecting dried paint
films from bacterial or fungal attack.
This product is for industrial use only. It is
added at a point in the paint manufacturing process
where there is sufficient time and agitation for
good dispersion. Product is added as a liquid, dry
solid, or concentrated aqueous solution. Product
directions may specify addition at a specific phase
in the manufacturing process or to the raw materi-
als. Some products are used as a mixture with
other antimicrobial products. The exact product
concentration required will vary with the type of
system to be treated, the nature and extent of
microbiological contamination, the degree of con-
trol required, temperature, and pH. The exact
amount of product required is best determined by
actual test.
A24 Bacteriostat
158 ppm Bacteriostatic treatment for exterior latex paints
40 ppm (acrylic, PVA, water base latex paint). Add 0.02
(79% SC/S) percent of product based on the weight of the
paint.
Formulated with zinc 2—pyridinethiol 1—oxide.
FYABQBB Mold/mildew
1,980 ppm Mold/mildew control for exterior latex paints
500 ppm (acrylic, PVA, water base latex paint). Add 0.25
(79% SC/S) percent of product based on the weight of the
paint.
Formulated with zinc 2—pyridineth iol 1—oxide.
Issued: 3—11—85 V.1—077402—24
49
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
/S1O100A Paper and Paper Prod-
ucts
General Instructions for Use : The products regis-
tered in this site are used to control the growth
of bacteria and fungi on paper and paper products.
Apply products according to the following methods
of application.
8eater application : Add product to the pulp at the
beaters. The degree of retention of the active in-
gredient(s) will depend on the nature of other ad-
ditives in the system.
Spray application : Spray paper uniformly with the
product. Use conventional spray equipment. Con-
duct application in a spray booth or well ventilat-
ed area.
Impregnation application : Apply product to the dry
end of the paper machine or as an off—the—machine
operation. Apply by size press, rolicoater, calen-
dar, or pad bath.
A24 Bacteriostat
250—2,500 ppm Bacteriostatic treatment for paper. Add 0.25 per—
1,950—19,500 ppm cent to 2.5 percent of product based on the weight
(107. RTU) of the paper.
Formulated with isopropanol.
/8IM1IOA Plastics and Polymers
General Lnstructions for Use : The products regis-
tered in this site are bacteriostats and fungistats
for use in plastic, plastic products and synthetic
polymers. The majority of products included in
this ection are incorporated as antimicrobial ad-
ditives of plastics, plastic films, vinyl, and
other synthetic polymers during the manufacturing
process. These products are intended to control
the growth of bacteria and fungi during the service
life of the plastic or polymer. Other products in-
cluded in this section are intended for the treat-
ment of plastic surfaces or are impregnated plasti-
cized vinyl products which claim residual bacterio—
static activity.
Mixing or Milling application : Incorporate product
into the plastic mix. Mix thoroughly to ensure
even dispersion.
Issued: 3—11—85 V.1—077402—25
50
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
Plastics and Polymers (continued)
Spray application : Apply by conventional spray
equipment. Spray plastic uniformly with the prod-
uct. Conduct application in a spray booth or well
ventilated area.
A24 Bacteriostat
FYABQBB Mold/mildew
2,000 ppm Product is a bacteriostatic disposable plastic gar—
3,700 ppm bage bag.
(0.2% Impr) Formulated with dirnethyl phthalate and 5—chloro—2—
(2 ,4—dichlorophenoxy)phenol.
3,160 ppm Bacteriostatic treatment and mold/mildew control
800 ppm for PVC plastic (non—food use). Add 0.4 percent
(79% SC/S) of product based on the weight of the plastic.
Formulated with zinc 2—pyridinethiol 1—oxide.
19,400 ppm Bacteriostatic treatment for plastic. Add 0.4 per—
400 ppm cent of product based on the weight of the resin.
(99% SC/S)
/810140A Specialty Products
General Instructions for Use : The product regis-
tered in this site is for use in miscellaneous
products nor included in other Industrial Preserva-
tive sites. This includes solutions and emulsions
of unspecified use, joint cements, protein col—
bids, inks, dyes, ceramic glazes, waxes, polishes,
cleansers, liquid detergents, photographic solu-
tions, fire extinguisher solutions, milk samples
(Babcock), and air filter materiaL.
Add product during the manufacturing process and
mix thoroughly to ensure uniform distribution.
A24 Bacteriostat
99 ppm Bacteriostatic treatment for dry wall joint cement.
25 ppm Add 0.0125 percent of product based on the weight
(79% SC/S) of the cement.
Formulated with zinc 2—pyridinethiol 1—oxide.
Issued: 3—11—85 V.1—077402—26
51
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
/810150A Textiles
General Instructions for Use : The products regis-
tered in this site are bacteriostats and fungistats
for use on textile fabrics during the manufacturing
process. Many products are incorporated into the
textile fabric for residual bacteriostatic and fun—
gistatic activity. The products are for industrial
use only.
Padding operations : When product is incorporated
into the fabric during padding operations, it is
necessary to know the liquid pick—up value of the
textile material in order to determine the neces-
sary use concentration of the product. If the liq-
uid pick—up is 50 percent, to deposit 0.5 percent
of product requires a 1 percent product concentra-
tion in the treatment bath. The percentage of
product deposited is calculated based on the dry
weight of the textile fabric.
Product may be applied by immersion, spray, pad—
ders, or in a dyebeck, jig, paddle machine, or
rotary wheel.
Spray applications : Use conventional spray equip-
ment. Spray textile materia’ as uniformly as pos-
sible. Apply spray in a booth or well ventilated
area.
A24 Bacteriostat
280 ppm Bacteriostatic treatment for fabrics. Use 43 fluid
140 ppm ounces of product per 100 pounds of fabric.
(5 RTU) Formulated with N—lauryl diethylenetriamine.
501—2,500 ppm Bacteriostatic treatment for textiles. Add 0.05
390—19,500 ppm percent to 0.75 percent of product based on the dry
(10°!. RTU) weight of the textiles.
Formulated with isopropanol.
750—1,500 ppm Bacteriostatic treatment for textiles. Add 0.5
500—1,000 ppm percent to 1 percent of product based on the weight
(15’/ . RTU) of the textiles.
Formulated with 2,2’—methylenebis(3,4,6—trichloro—
phenol).
FYABQBB Mold/mildew
16 ppm Mold/mildew control for fabrics. Add 2 fluid
16 ppm ounces of product per 100 pounds of fabric.
(6.2% SC/L) Formulated with salicylanilide.
Issued: 3—11—85 V.1—077402—27
52
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
( Domestic and Human Uses )
/8bOO5OA Human Footwear
General Instructions for Use : The products regis-
tered in this site are for use on the inner sur-
faces of Street shoes, athletic shoes (bowling,
golf, tennis, etc.), skates, rental shoes, and
other footwear. May also be used on the exterior
surfaces of protective boots and shoes worn by
workers, farmers, hospital personnel, and veter-
inarians to decontaminate footwear and to aid in
reducing the spread of infectious organisms from 1
building or area to another.
Methods of Application.:
Spray : Spray surface until wet. Air dry.
Immersion : Dilute concentrate with water to obtain
required dilution. Immerse footwear in solution.
Observe required contact time. Rinse with water
if required. Air dry.
Wipe : Dilute concentrate with water to obtain re-
quired dilution. Wash surface with sponge, cloth,
or brusn dipped in solution. Rinse with water if
required. Air dry.
A18 Pseudomonacide
A19 Tuberculocide
A22 Disinfectant
A24 Deodorizer
A29 Fungicide
FYABQBB Mold/mildew
450 ppm Disinfection and mold/mildew control for shoes.
1,500 ppm Formulated with o—phenylphenol and 4—chloro-2—
(0.0457. PrL) cyclopentylphenol.
7,000 ppm Disinfection and mold/mildew control for shoes.
553,000 ppm Formulated with ethyl alcohol, o—phenylphenol, and
(0.7 PrL) N—lauryl diethylenetriamine.
Issued: 3—11—85 V.1—077402—28
53
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EPA Index to Pe tic ide Chemicals
Site, Efficacy , Use Directions
Dosage and Formulation
( Ba throoms )
/880030A Bathroom Premises
General Instructions for Use : The products regis-
tered in this site are for use in bathroom premises
(i.e. floors, walls, sinks, bathtubs, shower
stalls, toilet seats, toilet exterior surfaces,
and fixtures). Included are products for hospital,
institutional, comniercial, industrial, and house-
hold use.
Prec ean surfaces prior to treatment. A preclean—
ing step is not required for one—step disinfectant—
cleaners. Dilute product as directed. Apply by
mop, sponge, brush, cloth, or spray. Wet surfaces
thoroughly. Allow required contact time. Rinse
where required.
Porous surfaces such as grout and unfinished or
scarred surfaces may require a higher concentration
of solution than non—porous surfaces such as porce-
lain and tile.
For mold/mildew control, preclean hard non—porous
surfaces prior to treatment when required. Apply
by sponge, cloth, mop, or spray. Allow to dry.
Do not rinse. Repeat periou cally or when mold!
mildew growth appears.
A24 Bacter iostat
348 ppm Bacteriostatic treatment for surfaces.
521 ppm Formulated with auryl diethanolamide and N—lauryl
(37. SC/L) diethylenetriamine.
A18 Pseudomonacide
A19 Tuberculocide
A22 Disinfectant
A24 Deodorizer
A25 Virucide—effective against Influenza Type A2, Herpes simplex and Vaccinta
viruses
A29 Fungicide
FVABQBB Mold/mildew
2,000 ppm Disinfection and mold/mildew control on surfaces.
(0.2% RTU)
Issued: 3—11—85 V.1—077402—29
54
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EPA Index to Pesticide Chemicals
Site, Efficacy,
Dosage and Formulation
Use Directions
Bathroom Premises (continued)
14 ppm
3,400 ppm quat
421,000 ppm
(0.0014% PrL)
134 ppm
1,000 ppm quat
450,000 ppm
(0.0134% PrL)
200 ppm
3,800 ppm
(0.02% PrL)
240 ppm
786,000 ppm
(0.024% PrL)
500 ppm
1,500 ppm
(0.05% PrL)
2,000 ppm
9,400 ppm
(0.2% PrL)
2,000 ppm
2,500—5,000 ppm
quat
437,000—629,000
(0.2% PrL)
2,000 ppm
2,500—5,000 ppm
quat
412,000—628,000 ppm
(0.2% PrL)
3,600 ppm
550,000 ppm
(0.36% PrL)
7,000 ppm
553,000 ppm
(0.7% PrL)
Issued: 3—11—85
Disinfection of surfaces.
Formulated with isopropanol, al.kyl*dimethyl benzyl
ainxnonium chloride a1ky1 (60% C14, 30% C16, 5% C12,
5% C18), alkyl*dimethyl ethylbenzyl ammonium chlo-
ride *alkyl (50% ClZ, 30% C14, 17% C16, 3% C18),
and bis(tributyltin)oxide.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl aLcohol, alkyl*dimethyl ben—
zyl ammontum chloride *alkyL (60% C14, 30% C16, 5%
C12, 5% C18), alkyl*dimethyl ethylbenzyl ammonium
chloride *alkyl (68% C12, 32% C14), and triethylene
glycol.
Disinfection and mold/mildew control on surfaces.
Formulated with o—phenylphenol, 4—chloro—2—cyclo—
pentyiphenol, and lauryl diethanolamide.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and o—phenylphenol.
Disinfection and mold/mildew control on surfaces.
Formulated with o—phenylphenol.
Disinfection and mold/mildew control on surfaces.
Formulated with polyvinylpyrrol.idone.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and alkyl*dimethyl
benzyl ammonium chloride *alkyl (507. C14, 40% C1.2,
ppm 10% C16).
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and methyldodecyl—
benzyl trimethyl amrnonium chloride 80% and methyl—
dodecylxylylene bis(trimethyl ammonium chloride)
20%.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol, o—phenylphenol , and
4—chloro—2—cyclopentylphenol.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol, o—phenylphenol, and
N—lauryl diethylenetriamine.
V.1—077402—30
55
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
/880090A Diaper Pails
General Instructions for Use : The products regis-
tered in this site are for use on diaper pail sur-
faces against pathogenic and/or odor—causing bac-
teria.
Preclean diaper pail with soap or detergent and
rinse before disinfectant treatment. For one—step
disinfectant—cleaners, remove heavy organic soil
prior to treatment. Dilute product with water as
directed. Observe required contact time.
Pressurized liquid formulations are to be sprayed
from a distance of 6 to 12 inches. Spray surface
until thoroughly wet. Allow surface to dry. For
one—step disinfectant—cleaners, wipe surface clean
with a sponge or cloth after application.
For mold/mildew control, preclean hard non—porous
surfaces prior to treatment when required. Apply
by sponge, cloth, mop, or spray. Allow to dry.
Do not rinse. Repeat periodically or when mold/
mildew growth appears.
Pseudomonac ide
Tuberculoc ide
Dis infectant
Deodorizer
Virucide—effective against Influenza Type A2 virus
Fungic ide
Mold/mildew
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol, alkyl*dimethyl ben—
zyl ammonium chloride *alkyl (60% C14, 307. Cl6, 5%
C12, 5% cI a), alkyl*dimethyl ethylbenzyl ammonium
chloride *alkyl (68% C12, 327. C14), and triethylene
glycol.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and methyldodecyl-
ppm benzyl trimethyl ammonium chloride 80% and methyl
dodecylxylylene bis(trtmethyl ammonium chloride)
20%.
A18
Al9
A2 2
A2 4
A2 5
A2 9
FYABQ BB
134 ppm
1,000 ppm quat
450,000 ppm
(0.0134% PrL)
2,000 ppm
2,500—5,000 ppm
438,000—629,000 ppm
(0.27. PrL)
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and alkyl*dimethyl
benzyl ammonium chloride *alkyl (50% C14, 40% Cl2,
10% c16).
2,000 ppm
2,500—5,000 ppm
412,000—628, 000
(0.2% PrL)
Issued: 3—11—85 v.1—077402—31
56
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EPA Index to Pesticide Chemicals
Site, Efficacy,
Dosage and Formulation
Use Directions
/880040A Toilet Bowls and Uri-
nals
General Instructions for Use:
tered in this site are for use
urinal surfaces and water.
The products regis—
on toilet bowl and
Pressurized liquid formulations are to be sprayed
from a distance of 6 to 12 inches. Spray surface
until thoroughly wet. Allow surface to dry. For
one—step disinfectant—cleaners, wipe surface clean
with a sponge or cloth after application.
For mold/mildew control, preclean hard non—porous
surfaces prior to treatment when required. Apply
by sponge, cloth, mop, or spray. Allow to dry.
Do not rinse. Repeat periodically or when mold!
mildew growth appears.
Pseudomonac ide
Tuberculoc ide
Disinfectant
Deodorizer
Virucide—effective against Influenza Type A2, Herpes simplex and Vaccinia
viruses
A29 Fungicide
FYABQBB Mold/mildew
200 ppm
3,800 ppm
(0.02% PrL)
240 ppm
786,000 ppm
(0.024% PrL)
2,000 ppm
2,500—5,000 ppm
quac
445,000—629,000 ppm
(0.2% PrL)
2,000 ppm
2,500—5,000 ppm
quat
412,000—628,000 ppm
(0.2% PrL)
3,600 ppm
550,000 ppm
(0.36% PrL)
Issued: 3—11—85
Disinfection and mold/mildew control on surfaces.
Formulated with o—phenylphenol, 4—chloro—2—cyclo—
pentyiphenol, and lauryl diethanolamide.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and o—phenylphenol.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and alkyl*dimethyl
benzyl ainruonium chloride alkyl (507. C14, 407. C12,
10% Cl6).
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and methyldodecyl—
benzyl trimethyl ammonium chloride 80% and methyl—
dodecylxylylene bis(trimethyl aminonium chloride)
20%.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol, o—phenylphenol, and
4—chloro—2—cyc lopentylpheno 1.
V. 1—077402—32
Al S
A 19
A2 2
A2 4
A2 5
57
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
( Laundry )
/87007HE Diapers (Household)
General Instructions for Use : The product regis-
tered in this site iS for use on small loads of
diapers. The products provide instructions for
hand washing, use in small automatic machines, or
dosages based on 10 pounds of dry fabric. Products
in this section are for household use or for gen-
eral use. The object of control of the residual
bacteriostats is to inhibit the growth of odor—
causing and ammonia—producing bacteria (i.e.
Brevibacterium ammoniagenes. ) which act on urine
in diapers. Residual antimicrobial activity is
effective only under conditions of high relative
humidity or wet contamination.
For Use : Do not pour product directly on diapers.
Add product to water before immersing diapers.
Methods of Application :
I) Wash Water Additive :
a) Hand washing . Add product to wash water and
add detergent if directed. T nmerse diapers and
allow them to remain in water for a minimum of 5
minutes while washing.
b) Automatic machine . Add product to wash water.
2) First rinse additive :
a) Hand washing . Squeeze suds from diapers.
Prepare a dilute solution of product and soak
diapers in solution for a minimum of 5 minutes.
Rinse all trace of product from diaper with final
rinse.
b) Automatic machine . No applications.
3) Final rinse additive :
a) Hand washing . Rinse all soap from diapers.
Immerse diapers in dilute solution of product for
5 minutes.
b) Automatic machine . Add product to final rinse
cycle.
A24 Bacteriostat
8 ppm Bacteriostatic treatment for diapers.
(0.157. sc/s)
Issued. 3—11—85 V.1—077402—33
58
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EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
/87007HE Diapers (Presoak)
General Instructions for Use : The product regis-
tered in this site is for the treatment of soiled
diapers prior to laundering. The treatment is in-
tended to destroy or inhibit the growth of odor—
causing bacteria.
Methods of Application:
Presoak—Diaper Pail . Remove substantial soil by
flushing diaper in toilet. Add product to clean
water in diaper pail to prepare proper dilution or
add ready—to—use product directly to pail. Soak
soiled diapers in product solution until ready to
launder.
Washing Machine . Remove substantial soil by flush-
ing diaper in toilet. Add product to water in
washing machine to achieve proper dilution. Agi-
tate diapers and soak for recommended contact time.
Add soap or detergent and wash.
A24 Bacteriostat
44 ppm Bacteriostatic treatment for diapers.
(0.15% SC/S)
/87006H0 Laundry (Hospital,
Commercial and
Institutional)
General Instructions for Use : The products regis-
tered in this site are for use in the treatment of
laundry (i.e. washable fabrics such as clothing,
linens, sheets, towels, blankets, uniforms, and
bathing suits) in commercial, institutional, and
medical establishments (i.e., schools, resturants,
hotels, motels, athletic facilities, and hospi-
tals)
Fabrics are treated in bulk or multifamily laundry
loads. Commercial machines typically handle 50 to
100 pounds of fabric per load and have a lower
fabric—to—water weight ratio (1:3 to 1:5) than home
washing machines (1:10 to 1:15).
Do not pour bleach, quaternary ammonium compounds
or other soluble concentrates directly on fabrics.
Add to wash wheel after machine has filled with
water or dilute product in a gallon of water and
add this solution to laundry.
Issued: 3—11—85 V.1—077402—34
59
-------
EPA Index to Pesticide Chemicals
Site, Efficacy, Use Directions
Dosage and Formulation
Laundry (Hospital, Commercial and Institutional ) (continued)
Methods of Application:
Presoak . Prepare product dilution. Immerse con-
taminated fabric in solution. Allow for a minimum
of 10 minutes contact time. Wash fabric after
soaking.
Prerinse additive . Spin fabric dry. Add product
to wash wheel during prerinse cycle.
Wash water additive . Add product to wash water
with or without detergent as directed. Rinse fab-
ric following treatment.
First rinse additive . Wash fabric. Add product
to first rinse water. Rinse fabric following
treatment.
Final rinse additive . Wash fabric and rinse free
of all detergent. Add product to final rinse
water or sour cycle.
A24 Bacteriostat
9—12 ppm Bacteriostatic treatment for laundry.
(0.6% sc/s)
24—146 ppm Bacteriostatic treatment for laundry.
(3.11% SC/L)
/87006HE Laundry (Household )
General Instructions for Use: The product regis-
tered in this site is for use in the treatment of
household laundry (i.e. clothing, linens, sheets,
towels, and dish cloths).
Do not pour quaternary ammonium compound products
directly on fabric. Add product after machine has
been filled with water.
Methods of Application:
Presoak . Prepare product dilution. Immerse con-
taminated fabric in solution. Allow for a minimum
of 10 minutes contact time. Wash fabric after
soaking.
Wash water additive (machine or handwash) . Add
product to wash water. Rinse fabric following
treatment.
Issued: 3—11—85 V. 1—077402—35
60
-------
EPA Index to Pesticide Chemicals
Site, Efficacy,
Dosage and Formulation
Use Directions
Laundry (Household ) (continued)
First rinse additive .
to first rinse water.
treatment.
Wash fabric. Add product
Rinse fabric following
A24
Bac terios tat
Final rinse additive (machine or handwash) .
fabric and rinse free of all detergent. Add
product to final rinse water or sour cycle.
Wash
4—8 ppm
(0.15% SC/s)
Bacteriostatic treatment for laundry.
/870120A Laundry (Mattresses,
Pillows and Draper-
ies )
General Instructions for Use :
tered in this site are for use
lows, and draperies.
The products regis—
on mattresses, pu—
A18
AZ 2
A2 4
FYABQBB
Pseudomonac ide
Disinfectant
Deodorizer
Mold/mildew
Spray product onto fabric until surface is moist.
Allow product to dry before use. Fabric is treated
before use or between uses.
14 ppm
3,400 ppm quat
421,000 ppm
(0.0014% PrL)
500 ppm
1,500 ppm
(0.05% PrL)
Issued: 3—11—85
Disinfection of mattresses, pillows, and draperies.
Formulated with isopropanol, alkyl*dimethyL benzyl
ammonium chloride *alkyl (60% C 14, 30% C16, 5% C12,
5% C18), alkyl*dimethyl ethylbenzyl ammonium chlo-
ride *alkyl (50% CU, 30% C14, 177. C16, 37. C18),
and bis(tributyltin)oxide.
Disinfection and mold/mildew control on mattresses,
pillows, and draperies.
Formulated with o—phenylphenol.
V.1—077402—36
61
-------
EPA Index to Pesticide Chemicals
Site, Efficacy,
Dosage and Formulation
( Refuse )
Use Directions
/890010A Garbage Containers
General Instructions for Use :
tered in this site are for use
surfaces.
The products regis—
on garbage container
Clean and rinse surfaces prior to treatment. One—
step disinfectant—cleaners and sanitizer—cleaners
do not require a precleaning step. Dilute product
as directed on label. Application is by wipe, mop,
swab, wash, rinse, or spray. Observe required
contact time.
Pseudomonac ide
Tuberculocide
Disinfectant
Deodorizer
Virucide—effective against Influenza Type A2, Herpes simplex and Vaccinia
viruses
14 ppm
3,400 ppm quat
421,000 ppm
(0.0014% PrL)
134 ppm
1,000 ppm quat
450,000 ppm
(0.0134% PrL)
240 ppm
786,000 ppm
(0.024% PrL)
500 ppm
1,500 ppm
(0.05% PrL)
2,000 ppm
2,500—5,000 ppm
qua t
438,000—629,000
(0.2% PrL)
Issued: 3—11—85
Disinfection of surfaces.
Formulated with isopropanol, alkyl*dimethyl benzyl
ammonium chloride *alkyl (b0 C14, 307 C16, 5% C12,
5% C18), alkyl*dimethyl ethylbenzyl ammonium chlo-
ride *alkyl (50% C12, 30% C14, l7 C16, 3% c18),
and bis(tributyltin)oxide.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol, alkyl*dimethyl ben—
zyl aminonium chloride *alky]. (60% C14, 307. Cl6, 5%
Cl2, 5% C18), alkyl*dimethyl ethylbenzyl ammonium
chloride *alkyl (68% C12, 32% C14), and triethylene
glycol (083501).
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and o—phenylphenol.
Disinfection and mold/mildew control on surfaces.
Formulated with o—phenylphenol.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and alkyl*dimethyl.
benzyl ammonium chloride *alkyl (50% C14, 40% C12,
ppm 10% C16).
V. 1—077402—37
Al 8
A19
AZ 2
A2 4
AZ 5
A29 Fungicide
FYABQBB Mold/mildew
62
-------
EPA Index to Pesticide Chemicals
Site, Efficacy,
Dosage and Formulation
Use Directions
Garbage Containers (continued)
2,000 ppm
2,500—5,000 ppm
quat
412,000—555,000 ppm
(0.2% PrL.)
3,600 ppm
550,000 ppm
(0.36% PrL)
7,000 ppm
553,000 ppm
(0.7% PrL)
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol and methyldodecyl—
benzyl trimethyl ammonium chloride 80°h and methyl—
dodecylxylylene bis(trimethyl arnmonium chloride)
20%.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol, o—phenylphenol, and
4 —chloro—2—cyc lopentyiphenol.
Disinfection and mold/mildew control on surfaces.
Formulated with ethyl alcohol, o—phenylphenol, and
N—lauryl diethylenetrianune.
( Miscellaneous Indoor Uses )
/900l90A Air Sanitizers
A23
San it izer
General Instructions for Use : The products regis-
tered in this site are for use as air sanitizers
to reduce the number of airborne bacteria and
viruses. These products may be for commercial
(i.e. bathrooms, washrooms, auditoriums, public
rooms, hotels, theaters, hospitals, factories,
mills, schools, and department stores) and house-
hold use.
Spray application . For products that are pressur-
ized liquids marketed in pressurized spray contain-
ers, spray into air manually. For products regis-
tered for use in manufacturer’s automatic dispens-
ing devices, insert pressurized container in de-
vice. Preset device to depress valve of pressuriz-
ed container at the desired evenly spaced inter-
vals. Hang dispenser device above eye level in
room to be treated. Do not instal.l device in nur-
series or rooms where infants, ill, or aged people
are confined.
134 ppm
1,000 ppm quat
450,000 ppm
(0.0134% PrL)
240 ppm
786,000 ppm
(0.024% PrL)
Issued: 3—11—85
Sanitization of air.
Formulated with ethyl alcohol, alkyl*dimethyl ben—
zyl ammonium chloride *alkyl (60% C14, 30% C16, 5%
Cl2, 5% C18), alkyl*dimethyl ethylbenzyl ammonium
chloride *alkyl (68% C12, 32% C14), and triethylene
glycol.
Sanitization of air.
Formulated with ethyl alcohol and o—phenylphenol.
V.1—077402—38
63
-------
EPA Index to Pesticide Chemicals
Site, Efficacy,
Dosage and Formulation
Use Directions
Air Sanitizers (continued)
450 ppm
1,500 ppm
(0.0457 PrL)
Sanitization of air.
Formulated with o—phenylphenol and 4—chloro—2—
cyc lopentyiphenol.
2,000 ppm
2,500—5,000 ppm
437,000—629,000
(0.2% PrL)
Sanitization of
Formulated with
ppm benzyl aminonium
10% c16).
air.
ethyl alcohol and alkyl*dimethyl
chloride *alkyl (50% C14, 40% C12,
2,000 ppm
5,000 ppm quat
518,000—628,000
(0.2% PrL)
3,600 ppm
550,000 ppm
(0.36% PrL)
10,000 ppm
280,000 ppm
(1% PrL)
/900050A Filters (Air Condition-
ing, Air and Furnace )
Sanitization of air.
Formulated with isopropanol.
A24
Bac ter ios tat
Preclean filters by flushing
uCt in appropriate dilution.
sponge, spray, or immersion.
tact time.
14 ppm
3,400 ppm
421,000 ppm
(0.0014% PrL)
Issued: 3—11—85
Bacteriostatic treatment for filters.
Formulated with isopropanol, alkyl*dimethyl benzyl
ammonium chloride *alkyl (60% C14, 30% C16, 5% C12,
5% C18), alkyl*dimethyl ethylbenzyl ammonium chlo-
ride *a lkyl (50% C12, 30% C14, 17% C16, 3% cIa),
and bis(tributyltin)oxide.
V.1—077402—39
Sanitization of air.
Formulated with ethyl alcohol and methyldodecyl—
ppm benzyl trimethyl ammonium chloride 80% and methyl-
dodecylxylylene bis(trimethyl ammonium chloride)
20%.
Sanitization of air.
Formulated with ethyl alcohol, o—phenylphenol, and
4—chloro—2—cyclopencylphenol.
General Instructions for Use : The product regis-
tered in this site is a residual bacteriostat for
air—conditioning, air, and furnace filters.
with water. Use prod—
Apply product by
Allow specified con—
64
-------
EPA Index to Pesticide Chemicals
Listing of Registered Pesticide Products by Formulation
&090.0002 90% formulation intermediate
4’,5—dibromosalicylanilide (077402)
3,4’ ,5—tribromosalicylanilide (077404)
001457—00043
&099.0002 99% formulation intermediate
3,4’,5—tribromosalicylanilide (077404)
3,5—dibromosalicylanilide (077405)
009571—00003
&099.9902 100% formulation intermediate
4’ ,5—dibromosalicylanilide (077402)
3,4’ ,5—tribromosalicylanilide (077404)
001457—00047
&000.2010 0.2% impregnated materials
3 ,4’,5—tribromosalicylanilide (077404)
dimethyl phthalate (028002)
5—chloro—2—(2 ,4—d ichlorophenoxy)phenol (054901)
00 7101—00003
&000.1515 0.15% soluble concentrate/solid
3,4’ ,5—tribromosalicylanilide (077404)
001624—00028
&000.6015 0.6% soluble concentrate/solid
3,4’,5—tribromosal icylanilide (077404)
006142—00016
79°!. soluble concentrate/solid
4’ ,5—dibromosalicylaniI.jde (077402)
3,4’ ,5—tribromosalicylanilide (077404)
3,5—dibromosalicylanilide (077405)
zinc 2—pyridinethiol 1—oxide (088002)
001 2 58—00889
&099.00l5 997. soluble concentrate/solid
3 1 4’,5—tribromosalicy lanilide (077404)
003090—00098
3 , 4 ’,5—tribromosal icylanilide (077404)
3,5—dibromosal.icylanilide (077405)
006390—00029
Issued: 3—11—85 V.1—077402—40
&079.OOl 5
45.00%
45.00%
90. 00%
9 7.00%
2.00%
99.00/.
0.05/.
99. 9 5%
100.00%
0.20%
0.35%
0.02%
0.5 77 .
0.15%
0.6%
36 007
36.00/.
7.00/.
20.00/ .
99. 00%
99. 00%
97.00/.
2 00’ !
99.00/.
65
-------
EPA Index to Pesticide Chemicals
Listing of Registered Pesticide Products by Formulation (continued)
0.02% soluble concentrate/liquid
3,5—dibromosalicyLanhlide (077405)
o--benzyl—p—chlorophenol (062201)
p—terc—amylphenol (064101)
o—phenylphenol, sodium salt (064104)
005664—00039
0.1% soluble concentrate/liquid
3,4’ ,5—tribromosaL icylan ilide (077404)
3,5—dibromosalicylanilide (077405)
alkyl*dimethyl benzyl ammonium chloride *alkyl (60% C14,
30% C16, 5% C12, 5% Cl8) (069104)
alkyl*dimethyl ethylbenzyl ammonium chloride *alky].
(50% C12, 30% C14, 17% C16, 3% C18) (069111)
N_alkyl*_N_ethyl morpholinium ethyl sulfate *alkyl
(92Z C18, 8% c16) (069113)
0003 34—00 246
&200.2515 0.25% soluble concentrate/liquid
4’ ,5—dtbromosalicylanilide (077402)
3,4’,5—tribromosalicylani .lide (077404)
000787 —0003 5
2% soluble concentrate/liquid
4’, 5—dibromosalicylantlide (077402)
3,4’ ,5—cribromosalicylanilide (077404)
o—benzyl—p—chlorophenol (062201)
p—tert—amylphenol (064101)
o—phenylphenol (064103)
propylene glycol (068603)
potassium hydroxide (075602)
potassium ricinoleate (079023)
00 5664—0003 7
3% soluble concentrate/liquid
4’ ,5—dibromosalicylan ilide (077402)
3,4’ ,5—tribromosalicylanilide (077404)
lauryl diethanolamide (079018)
N—lauryl diethylenetriamine (079055)
001457—00051
&203.lOl5 3.1% soluble concentrate/liquid
4’ ,5—dibromosalicylanilide (077402)
3,4’ ,5—tribromosalicylanilide (077404)
o—benzyl—p—chlorophenol, potassium salt (062202)
&200.02l5
&200. 1015
&202.0015
&203 .0015
0.02%
1.88%
1.00%
3.00%
5. 90%
0 08%
0.02%
0. 75%
0. 75%
0. 10%
1 707
0.20%
0.05%
0.25%
0.4 0%
1.60%
3.75h
2.00%
6.007.
6.00%
1.80%
9.OOY .
30. 55%
1 50%
1 507
3.00%
1.50%
7.50/.
1.55%
1.55%
5.00%
8. 10%
0060 18—00007
Issued: 3—11—85 V.1—077402—41
66
-------
EPA Index to Pesticide Chemicals
Listing of Registered Pesticide Products by Formulation (continued)
&203.lll5 3.11% soluble concentrate/liquid
4’ ,5—dibromosalicylanilide (077402)
3,4’,5—tribrornosalicylanilide (077404) ____
006018—00001
&206.2015 6.2% soluble concentrate/liquid
4’ ,5—dibromosaltcylanilide (077402)
3,4’ ,5—tribromosalicylanjlide (077404)
salicylanilide (077407) ______
000335—00199
&200.05 16 0.05% liquid—ready to use
3,4’ ,5—tribromosalicylanil ide (077404)
000 54 1—00099
4’ ,5—dibromosal.icylanilide (077402)
3,4’ ,5—tribromosalicylanilicie (077404) ____
000 54 1—00103
4’ ,5—dlbromosalicylanii.ide (077402)
3,4’,5—tribrornosa licylanilide (077404) ____
000541—00171
0.04%
0.16%
0.20%
5’/. liquid—ready to use
4 ’,S—dibromosalicylanilide (077402) 2.50%
3,4’ ,5—tribromosa licylanilide (077404) 2.50%
N—lauryl dietl -tylenetriamine (079055) 2.50%
7.50%
001457—00048
10% liquid—ready to use
4’ ,5—dibromosal icylan i ljde (077402) 0.09%
3,4’ ,5—tribromosalicylanilide (077404) 9.60%
3,5—dibromosal icylanil icie (077405) 0.31%
isopropanol (047501) 78.00%
88.00%
003090—00152
&215.0016 15% liquid—ready to use
3 ,4’,5—tribromosa l icylaniljde (077404)
2 1 2 ’—methylenebis(3,4,6—trichloroptienol) (044901)
1.56%
1.55%
3.11%
2.80%
3.40%
6 20%
l2.40,
0.05/.
0.01%
0.047 .
0.05%
0.03%
0.02%
0.05%
0.2% liquid—ready to use
4 ’,5—dtbromosalicylanilide (077402)
3,4’ ,5—tribromosalicylanilide (077404)
001624—00099
&200. 20 16
&205. 0016
&2l0. OOlô
003090—00153 003090—00154
003090—00194
Issued: 3—11—85 V.1—077402—42
15. 00%
10. 00%
25. 00%
67
-------
EPA Index to Pesticide Chemicals
Listing of Registered PestLcide Products by Formulation (continued)
6299.9916 100% liquid—ready to use
4’ ,5—dibromosalicylanilide (077402)
3,41 ,5—tr ibromosal icylanilide (077404)
3,5—dibromosalicylanilide (077405) ______
00 309 0—00 149
0.0014% pressurized liquid
3,4’ ,5—tribromosal icylanilide (077404)
isopropanol (047501)
alkyl*dimethyl benzyl ammonium chloride a1kyl (60% C14,
30% C16, 5% C12, 5% C18) (069104)
alkyl*dimethyl ethylbenzyl aminonium chloride alky1
(50% C12, 30% C14, 17% C16, 3% C18) (069111)
bis(tributyltin)oxide (083001) ________
001 769—00170
6200.0119 0.0134% pressurized liquid
4 1 ,5—dibromosal.icylanilide (077402)
3,4’ ,5—tribromosalicylanilide (077404)
ethyl alcohol (001501)
alkyl*dimethyl benzyl ammonium chloride *alkyl (60% C14,
30% C16, 5% C12, 5% C18) (069104)
alkyl*dimethyl ethylbenzyl ammonium chloride *alkyl
(68% C12, 32% Cl4) (069154)
triethylene glycol (083501) _______
000257—00295 010744—00006
0.02% pressurized liquid
4’ ,5—d ibromosalicylan ilide (077402)
o—phenylphenol (064103)
4—chloro—2--cyclopentylphenol (064202)
lauryl diethanolamide (079013)
005590—00061
0.025% pressurized liquid
3,4’,5—tribromosalicylan ilide (077404)
3,5—dibromosalicylanilide (077405)
ethyl alcohol (001501)
o—phenyl.phenol (064103)
000675 —0002 5
6200.0519 0.05% pressurized liquid
3,4’ ,5—tribromosal icylanilide (077404)
o—phenylphenol (064103)
000706—00023
Issued: 3—11—85 V.1—077402—43
6200.0019
0.90%
96. 00%
3.10%
100.00%
0.0014%
42. 0000%
0. 1700%
0 1700%
0.0500%
42.3914%
0. 006 7%
0. 006 7%
3 7.0000%
0. 0500%
0. 0500%
8. 0000%
45. 1134%
0.02%
0.10%
0.08%
0.20%
0.40%
0. 019%
0. 00 5%
78. 500/
0. 136%
78. 650%
0.05%
0.15%
0.20%
&200. 02 19
6200.0319
68
-------
EPA Index to Pesticide Chemicals
Listing of Registered Pesticide Products by Formulation (continued)
&200.2019 0.2% pressurized liquid
3,4’,S—tribromosalicylan ilide (077404) 0.20%
polyvinylpyrrolidone (079033) 0.94%
1.14%
005075—00020
4’,5—dibromosalicylanilide (077402) 0.0400%
3,4’ ,5—tribromosalicylantlide (077404) 0.1600%
ethyl alcohol (001501) 43.7425%
alkyl*dimethyl benzyl ammonium chloride *alkyl (50% C14,
40% C12, 10% C16) (069105) 0.2500%
44.1925%
005590—00144
4’ ,5—dibromosalicylantlide (077402) 0.04%
3,4’,5—tribromosalicylanilide (077404) 0.16%
ethyl alcohol (001501) 44.53%
alkyl*dimethyl benzyl ammonium chloride *alkyl (50% C14,
40% C12, 10% C16) (069105) 0.25%
44.98%
005590—00133
41 ,5—dibromosalicylanilide (077402) 0.04%
3,4’,5—tribroinosalicylanilide (077404) 0.16%
ethyl alcohol (001501) 62.90%
alkyl*dimethyl benzyl ammonium chloride *alkyl (507. C14,
40% Cl2, 10% C16) (069105) 0.50%
63. 60%
005590—00101
4’ ,5—dibromosalicylanilide (077402) 0.040%
3,4’,5—tribromosal icylanilide (077404) 0.160%
ethyl alcohol (001501) 41.246%
methyldodecylbenzyl trimethyl ammonium chloride 80% and
rnethyldodecylxylylene bis(trimethyl ammonium chloride)
20% (069129) 0.250%
41.696%
005 590—00056
4’ ,5—dibromosalicylan ilide (077402) 0.040%
3,4’,S—tribromosal icylanilide (077404) 0.160%
ethyl alcohol (001501) 51.775%
methyldodecylbenzyl trimethyl ainmonium chloride 80% and
methyldodecyixylylene bis(trimethyl ammonium chloride)
20% (069129) 0.5007 .
52 .4 7 57.
001266—00117
Issued: 3—11—85 V.1—077402—44
69
-------
EPA Index to Pesticide Chemicals
Listing of Registered Pesticide Products by Formulation (continued)
0.2% pressurized liquid (continued)
4’ ,5—dibrornosalicylanil ide (077402)
3,4’ ,5-tribromosal icylanilide (077404)
ethyl alcohol (001501)
rnethyldodecylbenzyl trimethyl ammonium chloride 80% and
methyldodecyixylylene bis(trimethyl ammonium chloride)
20% (069129) _____
005 5 90—0006 5
4’ ,5—dibromosalicylanilide (077402)
3,4’,5—trtbromosalicylanilide (077404)
ethyl alcohol (001501)
methyldodecylbenzyl trimethyl anunonium chloride 80% and
ruethyldodecyixylylene b is(trimethyl ammonium chloride)
20% (069129) _____
000385—00063
0.36% pressurized liguid
3,4’ ,S—tribromosalicylanilide (077404) 0.3600%
ethyl alcohol (001501) 54.8100%
o—phenylphenol (064103) 0. 1400%
4—chloro—2—cyclopentylphenol (064202) 0.0256%
55.33567 .
000334—00 296
0.7% pressurized liquid
4’,S—dibromosalicylanilide (077402) 0.357 .
3,4’,5—tribromosalicylaniltde (077404) 0.35%
ethyl alcohol (001501) 54.81%
o—phenylphenol (064103) 0.14%
N—lauryl diethylenetriamine (079055) 0.35%
56. 00%
006018—00013
17. pressurized liquid
4’,5—dibromosahcylanilide (077402) 0.45%
3,4’,5—tribromosalicylanilide (077404) 0.55%
isopropanol. (047501) 28.00%
29. 00%
000257—00210
000257—00293
025023—00001
0. 04%
0.16%
55. 53%
0.50%
56.23%
0.04%
0. 16%
62. 75%
0.50%
63 .4 57.
&200.36 19
6200. 7019
6201. 0019
Issued: 3—11—85
V.1—077402—45
70
-------
REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA sec. 3(c)(2)(B). The
tables following this section list the data required for
maintaining the registrability of each product.
EPA has determined that additional generic data described
in Table A must be submitted to EPA for evaluation in order
to maintain in effect the registration(s) of your product(s)
identified as an attachment to the cover letter accompanying
this guidance document. As required by FIFRA Sec. 3(c)(2)(B),
you are required to take appropriate steps to comply with
thi8 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 1 ! Must be Submitted . You may deter-
mine which generic data you must submit by consulting Table A
at the end of this chapter. That table lists the generic
data needed to evaluate the continued registrability of all
products, and the dates by which the data must be submitted.
The required studies must be conducted in accordance with
EPA approved protocols çsuch as those contained in the Pesticide
Assessment Guidelines 2, or data collected under the approved
protocols of the Organization for Economic Cooperation and
Development (OECD). If you do not wish to develop data
in support of certain uses appearing in your labeling, you
may delete those uses at the time you submit your revised
labeling.
For certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a “typical
formulation,” and in those cases EPA needs data of that type
Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient, regardless
of the product’s unique composition or specific use. Product—
specific data relate only to the properties or effects of a
product with a particular composition (or a group of products
with closely similar composition).
21 The Pesticide Assessment Guidelines are available in hard
copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va. 22161.
71
-------
for each major formulation category (e.g., emulsifiable concen-
trates, wettable powders, granulars, etc.) These are classified
as generic data and when needed are specified in Table A.
EPA may possess data on certain “typical formulations” but
not others. Note : •Typical formulation” data should not be
confused with product—specific data (Table B) which are
required on each formulation. Product—specific data are
further explained in Chapter III of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled “FIFRA
Section 3(c)(2)(B) Summary Sheet” [ EPA Form 8580—1, Appendix
11—3] for each of your products. On that form you must state
which of the following methods you will use to comply with
the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe will
satisfy the requirement, or state that you wilL generate
the data by conducting testing. If the test procedures
you will use deviate from (or are not specified in) the
Pesticide Assessment Guidelines or protocols contained in
the Reports of Expert Groups to the Chemicals Group,
Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must enclose the
protocols you will use.
OR
2. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly develop (or
share in the cost of developing) the data. If you elect
this option, you must notify EPA which registrant(s) are
parties to the agreement.
OR
3. File with EPA a completed “Certification of Attempt to
Enter Into an Agreement With Other Registrants for Develop-
ment of Data” (EPA Form 8580—6, Appendix II—4)*/
*1 FIFRA sec. 3(c)(2)(B) authorizes joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator’s decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
(Footnote continued on next page)
72
-------
OR
4. Request that EPA amend your registration by deleting
the uses for which the data are needed. (This option is
not available to applicants for new products.)
OR
5. Request voluntary cancellation of the registration(s)
of your products for which the data are needed. (This option
is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required data
or how quickly the data must be submitted. If the test
procedures you plan to use deviate from (or are 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.
(Footnote continued from previous page)
In EPA’s opinion, joint data development by all regis-
trants subject to a data requirement or a cost—sharing agreement
among all such registrants is clearly in the public interest.
Duplication of testing could increase costs, tie up testing
facilities, and subject an unnecessarily large number of
animals to testing.
As noted earlier, EPA has discretion to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). EPA has concluded that
it should encourage joint testing rather than duplicative
testing, and that suspension should be withheld in certain cases.
to further this goal. Accordingly, If (1) a registrant has
Informed us of his Intent to develop and submit data required
by this Notice; and (2) a second registrant Informs EPA that
it has made a bona fide offer to the first registrant to share
in the expenses of the testing [ on terms to be agreed upon
or determined by arbitration under FIFRA Section 3(c)(2)(B)(iii)];
and (3) the first registrant has declined to agree to enter
into a cost—sharing agreement, EPA will not suspend the
second firm’s registration.
73
-------
The extension request should state the reasons why you believe
that an extension is appropriate. While EPA considers your
request, you must strive to meet the deadline for submitting
the required data.
74
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 3,4’,5—TBS
Data
Must
Be
Guideline Citation and
Test
Guidelines
Are
Data
Footnote
Submitted
Within
Name
of Test
Substance
Status
Required
Yes No
Number
Time
Below
Frames
1/
Listed
§158.120 Product Chemistry
Product Identity :
61—! — Identity of Ingredients TGAI R [ ] Li ______________ 6 Months
61—2 — Description of Beginning Materials TGAI R [ X I 1_I ______________ 6 Months
and Manufacturing Process
61—3 — Discussion of Formation of TGAI R [ J [ 1 _____________ 6 Months
Impurities
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis TGAI R [ ] [ 1 _____________ 12 Months
62—2 — Certification of Limits TGAI R [ ] [ ] ______________ 12 Months
62—3 — Analytical Methods to Verify TGAI R [ Xi [ 1 _____________ 12 Months
Certified Limits
Physical and Chemical Characteristics
63-2 — Color TGAI R I] [ XI _____________
63—3 — Physical State TGAI R [ I [ X] ______________
63—4 — Odor TCAI R [ 1 [ XI _____________
63—5 — Melting Point TGAI R [ ] [ J ______________ 6 Months
63—6 — Boiling Point TGAI N/A [ 1 [ XJ ______________
75
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 3,4’,S—TBS
uldeline Citation and
jme of Test
158.120 Product Chemistry (Continued)
‘ hysical and Chemical Characteristics
Continued)
63—7 — Density, Bulk Density, or ____________
Specific Gravity
63—8 — Solubility TCAI or PAl R ____________
63—9 — Vapor Pressure
63—10 — Dissociation constant
63—11 — Octanol/water partition
coefficient
63—12 — pH
63—13 — Stability
TGAI = Technical Grade of the Active Ingredient; PAl = Pure Active Ingredient; R = Required; CR = Conditionally Required
!/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
o 6 Month Due Date is June 30, 1986 .
o 12 Month Due Date is December 31, 1986 .
2/ These physical/chemical property data requirements are not required to support the registration of products under this
standard due to the minimal environmental impact of this chemical.
Test
Substance
must
Within
Guidelines
Are
Data
Footnote
Submitted
Listed
Status
Required
Yes No
Number
Time
Below
Frames
TGA I
[ 1 _____________ 6 Months
R [ i1
[ ]
R [ =1
R [ =1
R [ =1
R
R [ I ]
PAL
PA I
PA I
TGAI
TCAI
[ X]
[ XJ
[ XJ
EX]
[ XJ
[ X]
2
2
2
2
76
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 3,5—DBS; 4’S—DBS
Data
Must Be
Guideline Citation and
Test
Guidelines
Are Data
Footnote
Submitted Within
Name
of
Test
Substance
Status
Required
Yes No
Number
Time
Below
Frames
1/
Listed
§158.120 Product Chemistry
Product Identity:
61—1 — Identity of Ingredients
61—2 — Description of Beginning Materials
and Manufacturing Process
61—3 — Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis
62—2 — Certification of Limits
62—3 — Analytical Methods to Verify
Certified Limits
Physical and Chemical Characteristics
63—2 — Color
63—3 — Physical State
63—4 — Odor
63—5 — Melting Point
63—6 — Boiling Point
TCAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TCAI
TGAI
R
R
R
R
R
R
R
R
R
R
N/A
[ K]
[ XJ
[ XJ
[ XJ
[ X]
[ XJ
[ XJ
[ ]
[ X I
[ XI
Ej
[ 1
[ J
[ 1
[ ]
[ 1
[ 1
[ 1
[ 1
[ ]
[ 1
[ K]
6
6
6
12
12
12
6
6
6
6
Months
Months
Months
Months
Months
Months
Months
Months
Months
Months
77
-------
TABLE A
GENERIC DATA REQUIRE?€NTS FOR 3,5—DBS; 4’5—DBS
Data
must Be
Guideline Citation and
Test
Guidelines
Are Data
Footnote
Submitted Within
Name
of Test
Substance
Status
Required
Yes No
Number
Time
Below
Frames
,
Listed
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63—7 — Density, Bulk Density, or ____________
Specific Gravity
63—8 — Solubility ____________
63—9 — Vapor Pressure _____________
63—10 — Dissociation constant _____________
63—11 — Octanol/water partition ____________
coefficient
63—12 — pH ___________
63—13 — Stability _____________
TCAI = Technical Grade of the Active Ingredient; PAL = Pure Active Ingredient; R = Required; CR = Conditionally Required
!I Data must be submitted within the indicated time frame, based on the date of the Guidance Docura nt.
o 6 Month Due Date is June 30, 1986 .
o 12 Month Due Date is December 31, 1986 .
2/ These physical/chemical property data requirements are not required to support the registration of products under this
standard due to the minimal environmental impact of these chemicals.
TGAI
TGAI or
PAL
PAL
PAT
TGAI
TGAI
PAL
R
R
R
R
R
R
R
[ X]
[ XJ
[ =1
[ ]
[ 1
[ I
[ J
[ ]
[ J
[ x]
[ X I
El
[ XJ
[ 1
6
6
6
Months
Months
Months
2
2
2
2
78
-------
§158.135 Toxicology
ACUTE TESTING :
81—1 — Acute Oral Toxicity — Rat
81—2 — Acute Dermal Toxicity
— Rabbit
81—3 — Acute Inhalation Toxicity
— Rat
81—7 — Delayed
Neurotoxicity — Hen
SIJBCHRONIC TESTING :
82—1 — 90—Day Feeding
— Rodent, and
— Non-rodent (Dog)
21—Day Dermal — Rabbit
90—Day Dermal — Rabbit
90—Day Inhalation:
— Rat
82—5 — 90—Day Neurotoxicity:
— Hen
—Mammal
TGA I
TGA I
TGAI I
TGAI No
!/
Use 2/
Data Requirement Composition
Pattern
TABLE A
GENERIC DATA REQUIREMENTS FOR 3,4 ’,5—TBS;
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
3,5—DBS; 4’,S—DBS
Must Additional Data
Be Submitted Under
Bibliographic
FIFRA § 3(c)(2)(B)?
Citation
Time Frame for Data
Submission 3/
I
I
TGA I
TGAI
TGA I
TGA I
TGA I
I
I
I
No
No
No
No
No
No
No
No
82—2 —
82—3 —
82—4 —
Yes
Yes
Yes
No 4 /
Rese rved5/
Rese rved5/
Yes
Rese rved5/
9 Months
9 Months
9 Months
15 Months
18 Months
12 Months
15 Months
I
I
Reserved5/ 15 Months
No4 /
No4/
79
-------
— Rabbit
83—4 — Reproduction — Rat
2—generation
MUTAGENICITY TESTING
84—2 — Gene Mutation
84—2 — Structural Chromosomal
Aberration
84—4 — Other Genotoxic Effects
!/ Use 2/
Data Requirement Composition Pattern
TABLE A
GENERIC DATA REQUIREMENTS FOR 3,4’,S—TBS; 3,5—DBS; 4’,S—DBS
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Must Additional Data
Be Submitted Under
Bibliographic
FIFRA § 3(c)(2)(B)?
Citation
Time Frame for Data
Submission 3/
§158.135 Toxicology — Continued
CHRONIC TESTING :
83 —I — Chronic Toxicity -
2 species:
— Rodent, and
— Non—rodent (Dog)
83—2 — Oncogenicity —
2 species:
— Rat (preferred), and
— Mouse (preferred)
83—3 — Teratogenicity —
2 species:
- Rat
TCAI
I
No
Reserved5/
50
Months
Reserved5/
50
Months
TGAI
I
No
Reserved5/
50
Months
Reserved5/
50
Months
TGAI
I
No
Yes
15
Months
Yes
15
Months
TGAI
I
No
Reserved5/
39
Months
TGAI
I
No
Yes
9
Months
TGAI
I
No
Yes
12
Months
TGAI
I
No
Reserved5/
12
Months
80
-------
1/ Use 2/
Data Requirement Composition Pattern
TABLE A
GENERIC DATA REQUIREMENTS FOR 3,4’,5—TBS; 3,5—DBS; 4’,5—DBS
Does EPA Have
Data To Satisfy
This Require—
n nt? (Yes, No
or Partially)
Must Additional Data
Be Submitted Under
Bibliographic
FIFRA § 3(c)(2)(B)?
Citation
Time Fran for Data
Submission 3/
§158.135 Toxicology — Continued
SPECIAL TESTING
85—1 — General Metabolism
PAl
or PAIRA
I
No
Reserved5/
24
Months
Exposure Data
TGAI
TB
No
Yes /
18
Months
Leachability Data
TGAI
TB
No
YesL/
18
Months
Dermal Penetration
TGAI
TB
No
Yes8/
18
Months
81
-------
§158. 135 Toxicology — Continued
TABLE A
GENERIC DATA REQUIREMENTS FOR 3,4’,S—TBS; 3,5—DBS; 4’,5—DBS
!/ Composition: PAl 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: ATerrestrlal, Food Crop; BTerrestrial, Non—Food; CAqautic, Food Crop;
D=Aquatic, Non—Food; E=Greenhouse, Food Crop; F=Greenhouse, Non—Food; G=Forestry; HDomestlc Outdoor; Ilndoor;
TB=Textile Biocide.
3/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document....
o 9 Month Due Date is May 31, 1986.
o 12 Month Due Date is August 31, 1986.
o 15 Month Due Date is November 30, 1986.
o 18 Month Due Date is February 28, 1987.
o 24 Month Due Date is August 31, 1987.
o 39 Month Due Date is November 30, 1988.
o 50 Month Due Date is October 31, 1989.
This chemical is not an organophosphorous compound nor does it produce cholinesterase inhibition.
Depending on the outcome of the SPECIAL TESTING data required, the Agency will address these data requirements.
The data requirements are to be based on actual exposure, therefore the Registrant is requested to provide exposure
estimates or determinations on a mixture of all three chemicals under the conditions of use.
The data requirements are to be based on actual exposure, therefore the Registrant is requested to provide
leachability data on a mixture of all three chemicals at the highest percentage recommended on the label if the
intended use has the potential for direct body contact. Protocols to be used by the Registrant must be submitted
to the Agency prior to conducting the study.
The data requirements are to be based on actual exposure, therefore the Registrant is requested to provide dermal
penetration data for a mixture of all three chemicals at the highest percentage recommended on the label unless
under the conditions of use he has shown that there is no potential for leaching. Protocols must be submitted to
the Agency prior to conducting the study.
4/
5/
6/
7/
8/
-------
§158.130 Environmental Fate
DEGRADATION STUDIES—LAB :
161—1 — Hydrolysis
Photodegradat ion
161—2 — In water
161—3 — On soil
161—4 — In Air
METABOLISM STUDIES-LAB ;
162—1 — Aerobic Soil
162—2 — Anaerobic Soil
162—3 — Anaerobic Aquatic
162—4 — Aerobic Aquatic
MOBILITY STUDIES :
163—1 — Leaching and
Adsorption/Desorption
— Volatility (Lab)
— Volatility (Field)
No
No
No
No
No
No
1/ Use
2/
Data Requirement Composition Pattern
TABLE A
GENERIC DATA REQUIREMENTS FOR 3,4’,S—TBS;
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
3,5—DBS; 4’,5—DBS
Must Additional Data
Be Submitted Under
Bibliographic
FIFRA § 3(c)(2)(B)?
Citation
Time Frame for Data
Submission 3/
TGAI
or
PAIRA
I
No
Yes4/
TGAI
or
PAIRA
I
No
Yes 4 !
9
Months
TGAI
or
PAIRA
I
No
No
TGAI
or
PAIRA
I
No
No
TGAI
or
PAIRA
I
No
No
TGAI
or
PAIRA
I
No
No
TGAI
or
PAIRA
I
TGAI
or
PAIRA
I
TGAI
or
PAIRA
I
163—2
163—3
TEP I No
TEP I No
No
83
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 3,4’,5—TBS;
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
1/ Use 2/
Data Requirement Composition Pattern
3,5—DBS; 4’,5—DBS
Must Additional Data
Be Submitted Under
Bibliographic
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Citation
Submission 3/
§158.130 Environmental Fate — Continued
DISSIPATION STUDIES—FIELD :
164—1 — Soil
164—2 — Aquatic (Sediment)
164—3 — Forestry
164-4 — Combination and
Tank Mixes
164—5 — Soil, Long—term TEP
ACCUMULATION STUDIES :
165—1 — Rotational Crops PAIRA
(Confined)
165—2 — Rotational Crops TEP
(Field)
165—3 — Irrigated Crops TEP
165—4 — In Fish TGAI or PAIRA
165—5 — In Aquatic Non—Target TEP
Organisms
TEP
I
No
TEP
I
No
No
TEP
I
No
No
No
I No
I No
I No
No
I No
No
No
No
No
84
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TABLE A
GENERIC DATA REQUIREMENTS FOR 3,4’,5—TBS; 3,5—DBS; 4’,5-DBS
§158.130 Environmental Fate — Continued
!f Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end—use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non—Food; C=Aquatic, Food Crop;
DAquatic, Non—Food; E=Greenhouse, Food Crop; FCreenhouse, Non—Food; G=Forestry; H=Domestic Outdoor; Ilndoor.
3/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
o 9 Month Due Date is September 30, 1986 .
4/ These data are required because of the Aquatic Impact (direct discharge) use.
85
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 3,4’,5—TBS; 3,5—DBS; 4’,5—DBS
Does
EPA Have
Must Additional Data
Data
To Satisfy
Be Submitted Under
! /
Use 2/
This
Require—
Bibliographic
FIFRA 3(c)(2)(B)?
Tiuie Frau for Data
Data
Requirement
Composition
Pattern
ment? (Yes,
or Partially)
No
Citation
Submission 31
§158. 145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71—1 — Acute Avian Oral Toxicity TGAI No No
71—2 — Avian Subacute Dietary TGAI No Yes4/ 6 Months
Toxicity
71—3 — Wild Mammal Toxicity TGAI No No
71—4 — Avian Reproduction TGAI I No
- Upland Game Bird, and No
— Waterfowl No
71—5 — Simulated Field Testing TEP I No
— Mammals, and No
— Birds No
— Actual Field Testing TEP I No
— Mammals, and No
— Birds No
86
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 3,4’,S—TBS; 3,5—DBS; 4’,5—DBS
Does
EPA Have
Must Additional Data
Data
To Satisfy
Be Submitted Under
!/
Use 2/
This
Require—
Bibliographic
FIFRA § 3(c)(2)(B)?
Data
Requirement
Composition
Pattern
rnent? (Yes,
or Partially)
No
Citation
Time Frame for Data
Submission 3/
§158.145 Wildlife and
Aquatic Organisme — Continued
AQUATIC ORGANISM TESTING
72—1 — Freshwater Fish Toxicity TGAI I No
— Coidwater Fish Species, Yes 6 Months
and
— Warmwater Fish Species Yes 6 Months
72—2 — Acute Toxicity to TGAI No Yes 6 Months
Freshwater Invertebrates
72—3 — Acute Toxicity to TGAI I No
Estuarine and Marine
Organisms
— Fish No
— Mollusk No
— Shrimp No
72-4 — Fish Early Life Stage, TGAI I No No
and
— Aquatic Invertebrate No
Life—Cycle
87
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL 3,4’,5—TBS; 3,5—DBS; 4’,5—DBS
Does
EPA Have
Must Additional Data
Data
To Satisfy
Be Submitted Under
1/
Use
2/
This
Require—
Bibliographic
FIFRA § 3(c)(2)(B)?
Data
Requirement
Composition
Pattern
ment? (Yes,
or Partially)
No
Citation
Time Frame for Data
Submission 3/
§158.145 Wildlife and
Aquatic Organisms — Continued
72—5 — Fish — Life—Cycle TGAI I No No
72—6 — Aquatic Organism TGAI, PAl OR I No
Accumulation Degradation
Product
— Crustacean No
— Fish No
— Insect Nymph No
— Mollusk No
72—7 — Simulated Field Testing TEP I Mo No
— Aquatic Organisms
— Actual Field Testing No
—Aquatic Organisms
88
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 3,4’,5—TBS; 3,5—DBS; 4’,5—DBS
§158.145 WildlIfe and Aquatic Organisms — Continued
!/ Composition: TGAI Technical grade of the active ingredient; PAl = 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; CAquatic, Food Crop;
D=Aquatic, Non—Food; EGreenhouse, Food Crop; F=Greenhouse, Non—Food; C=Forestry; H=DomestIc Outdoor; I Indoor.
3/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
° 6 Month Due Date is June 30, 1986 .
4/ Only one species is required.
89
-------
III. REQUIREMENT FOR SUBMISSION OF PRODUCT—SPECIFIC DATA
Note: Unless stated otherwise in Section I, Regulatory
Position and Rationale, this Section applies only to manufac-
turing use products, not to end use products.
A necessary first step in determining which statements
must appear on your product’s label is the completion and
submission to EPA of product—specific data* listed on the
form entitled “Product Specific Data Report” (EPA Form
8580—4, Appendix Ill—I) to fill gaps identified by EPA
concerning your product. Under the authority of FIFRA sec.
3(c)(2)(B), EPA has determined that you must submit these
data to EPA in order to reregister your product(s). All of
these data must be submitted not later than six months after
you receive this guidance document.
Table B——Product—Specific Data Requirements for Manufacturing
Use Products——lists the product specific data you must submit.
Data that are required to be submitted are identified in the
column of those tables entitled “Must Data By Submitted
Under §3(c)(2)(B) .
*1 Product specific data pertain to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
90
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING—USE PRODUCTS CONTAINING 3,4’,5—TBS; 3,5—DBS; 4’,5—DBS
Data Must Be
Submitted Within
Time Frames Listed
Below 1/
Guideline Citation and
Test
Guidelines
Are
Data
Footnote
Name
of Test
Substance
Status
Required
Yes No
Number
§158.120 Product Chemistry
Product Identity:
61—1 — Product Identity and Disclosure
of Ingredients
MP
R
[ J
[ 1
6
Months
61—2 — Description of Beginning Materials
and Manufacturing Process
MP
R
E J
[ ]
6
Months
61—3 — Discussion of Formation of
Impurities
MP
R
[ J
[ ]
6
Months
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis
62—2 — Certification of Limits
62—3 — Analytical Methods to Verify
Certified Limit
MP
MP
MP
R
R
R
[ xi]
[ J
[ ]
[ J
[ =1
LI
12
12
12
Months
Months
Months
Physical and Chemical Characteristics
MP
tIP
HP
R
R
R
[ X I
[ ]
[ X]
[ ]
[ =1
[ 1
6
6
6
Months
Months
Months
63—2 — Color
63—3 — Physical State
63—4 — Odor
91
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TABLE B
PRODUCT SPECIFIC DATA REQUIRE 4ENTS FOR MANUFACTURING—USE PRODUCTS CONTAINING 3,4’,5—TBS; 3,5—DBS; 4’,5—DBS
Footnote
Submitted
Within
Guideline Citation and
Test
Guidelines
Are Data
Number
Time Frames Listed
Name
of
Test
Substance
Status
Required
Yes No
Below 1/
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63—7 — Density, Bulk Density, or HP R El ____________ 6 Months
Specific Gravity
63—12 — pH MP CR [ 1 IX ] 2
63—14 — Oxidizing or Reducing MP CR [ K] [ 1 ____________ 6 Months
Action
63—15 — Flammability MP CR [ K] [ 1 ____________ 6 Months
63—16 — Explodability MP R [ K] F_I ____________ 6 Months
63—17 — Storage Stability MP R [ ] E ] ____________ 15 Months
63—18 — Viscosity MP CR [ _] [ X I 3
63—19 — Miscibility MP N/A i_i E ] ____________
63—20 — Corrosion Characteristics MP R [ X] [ =] ____________ 15 Months
MP = Manufacturing—use Product; R Required; CR = Conditionally Required
Data must be submitted within the Indicated time frame, based on the date of the Guidance Document.
o 6 Month Due Date is June 30, 1986 .
o 12 Month Due Date is December 31, 1986 .
o 15 Month Due Date is March 31, 1987 .
2/ Not required due to the minimal environmental impact of these chemicals.
3/ Not required unless the product is a liquid.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING—USE PRODUCTS CONTAINING 3,4’,5—ThS; 3,5—DBS; 4’,5—DBS
Data Requirement
!/
Composition
Does EPA Have
Data To Satisfy
This Require—
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3/
§158.135 Toxicology
ACUTE TESTING
81—1 — Acute Oral Toxicity — Rat
MP
No
Yes 9 Months
81—2 — Acute Dermal Toxicity
— Rabbit
HP
No
Yes 9 Months
81—3 — Acute Inhalation Toxicity
- Rat
MP
No
Yes 9 Months
81—4 — Primary Eye
Irritation — Rabbit
MP
No
Yes 9 Months
81—5 — Primary Dermal
Irritation — Rabbit
HP
No
Yes 9 Months
81—6 — Dermal Sensitization —
Guinea Pig
MP
No
Reserved3/ 9 Months
!/ Composition: MP Manufacturing—use product.
2/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
° 9 Month Due Date is September 30, 1986 .
3/ Depending on the outcome of the SPECIAL TESTING data required, the Agency will address this data requirement.
93
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TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END—USE PRODUCTS CONTAINING 3,4’,5—TBS; 3,5—DBS;
Data
Must Be
Guideline Citation and
Test
Guidelines
Are Data
Footnote
Submitted Within
Name
of Test
Substance
Status
Required
Yes No
Number
Time
Below
Frames
/
Listed
EP
R
EP
[ X I
[ I
R
EP
[ X]
[ J
R
[ X]
[ I
§158.120 Product Chemistry
Product Identity:
61—1 — Product Identity and Disclosure
of IngredIents
6
Months
61—2 — Description of Beginning Materials
and Manufacturing Process
6
Months
61—3 — Discussion of Formation of
Impurities
6
Months
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis
62—2 — Certification of Limits
62—3 — Analytical Methods to Verify
Certified Limit
EP
EP
EP
[ 1
[ =1
[ =1
12
12
12
Months
Months
Months
Physical and Chemical Characteristics
EP
EP
EP
R
R
R
[ X]
E J
[ X I
[ 1
[ 1
[ 1
6
6
6
Months
Months
Months
63—2 — Color
63—3 — Physical State
63—4 — Odor
R
R
R
IX ]
[ XJ
[ X l
94
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TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END—USE PRODUCTS CONTAINING 3,4’,5—TBS; 3,5—DBS; 4’,5—DBS
Data Must Be
Guideline Citation and
Test
Guidelines
Are Data
Footnote
Submitted Within
Name
of
Test
Substance
Status
Required
Yes No
Number
Time Frames
Below 1/
Listed
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63—7 — Density, Bulk Density, or EP R [ XJ [ _J ____________ 6 Months
Specific Gravity
63—12 — pH EP CR [ XJ 1_I ____________ 6 Months
63—14 — Oxidizing or Reducing EP CR [ X l [ =1 _____________ 6 Months
Action
63—15 — Flammability EP CR [ X I [ 1 ____________ 6 Months
63—16 — Explodability EP R [ X] [ J ____________ 6 Months
63—17 — Storage Stability EP R [ X l [ 1 _____________ 15 Months
63—18 — Viscosity EP CR [ X l [ ] _____________ 6 Months
63—19 — Miscibility EP CR [ XJ [ 1 _____________ 6 Months
63—20 — Corrosion Characteristics EP R [ XI [ 1 _____________ 15 Months
EP = End—Use Product; R = Required; CR = Conditionally Required
!/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
o 6 Month Due Date is June 30, 1986 .
o 12 Month Due Date is December 31, 1986 .
o 15 Month Due Date is March 31, 1987 .
95
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TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END—USE PRODUCTS CONTAINING 3,4’,5—TBS; 3,5—DBS; 4’,5—DBS
Data Requirement
1/
Composition
Does EPA 1-lave
Data To Satisfy
This Require—
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3/
§158. 135 Toxicology
ACUTE TESTING
81—1 — Acute Oral Toxicity — Rat
EP
No
Yes 9 Months
81—2 — Acute Dermal Toxicity
— Rabbit
EP
No
Yes 9 Months
81—3 — Acute Inhalation Toxicity
- Rat
EP
No
Yes / 9 Months
81—4 — Primary Eye
Irritation — Rabbit
EP
No
Yes 9 Months
81—5 — Primary Dermal
Irritation Rabbit
EP
No
Yes 9 Months
81—6 — Dermal Sensitization —
Guinea Pig
EP
No
Yes4/ 9 Months
1, Composition: EP = End-Use Product
2/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
9 Month Due Date is September 30, 1986 .
3/ Required if the product is to be used as an aerosol.
4/ Required if repeated dermal exposure Is expected.
96
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TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING—USE PRODUCTS CONTAINING 3,4’,S—TBS; 3,5—DBS; 4’,5—DBS
Does EPA Have
Data To Satisfy
Must Additional Data
Be
!/
This Require—
Bibliographic
Under
FIFRA § 3(c)(2)(B)?
Data Requirement
Composition
ment? (Yes,
or Partially)
No
Citation
Time Frame for Data
3/
§158.160 Product Performance
Submission
Efficacy of Antimicrobial
Agents
91—2 — Products For Use On Hard
Surfaces
TEP
No
Yes2/ 6 Months
91—3 — Products Requiring
TEP
No
Yesa/ / 6 Months
Confirmatory Data
!I Composition: TEP = Typical end—use Product
2/ Data must be submitted for products bearing a claim to control microorganisms that pose a threat to human
health and whose presence cannot be readily observed by the user. Such microorganisms include, but are not
limited to, microorganisms infectious to man In any area of the inanimate environment. Products not meeting
this requirement need not submit efficacy data at this time. However, all registrants must have data available
to show that their products are efficacious when used in accordance with label directions and commonly accepted
pest control practices. The Agency reserves the right to require, when necessary, submission of efficacy data
for any proposed or registered pesticide product.
3/ This is to show similarity to products with sufficient data.
4/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
° 6 Month Due Date is June 30, 1986 .
97
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IV. SUBMISSION OF REVISED LABELING
Note : This section applies to all products.
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the results of data concerning the product and its ingredients.
Labeling requirements are set out in 40 CFR 162.10 (see
Appendix IV—1) and are summarized for products containing
this active ingredient as part of this Guidance Document
(See Appendix IV—2). Applications submitted in response to
this notice must include draft labeling for Agency review.
If you fail to submit revised labeling information
complying with this section (supplemented by requirements
described in Section I, Regulatory Position and Rationale),
EPA may issue a notice of intent to cancel the registration
under FIFRA sec. 6(b)(1).
A. Label Contents
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling . Specific label items
listed below are keyed to Appendix IV—2.
Item 1. PRODUCT NAME — The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS — The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS — A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., “1 pound 10 ounces” rather than
“26 ounces.’ In addition to English units, net contents may
be expressed in metric units. See Appendix IV—l. [ 40 CFR
162. LO(d)]
98
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Item 4. EPA REGISTRATION NUMBER — The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase “EPA Registration No.,” or “EPA
Reg. No.” The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required Identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix IV—l.
[ 40 CFR l 62 .l0(e)]
Item 5. EPA ESTABLISHMENT NUMBER — The EPA establishment
number, preceded by the phrase “EPA Est. is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
See Appendix IV—1. [ 40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT — An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. See Appendix IV—l. [ 40 CFR
1 62 .10(g)]
Item 6B. POUNDS PER GALLON STATEMENT — For liquid agricul—
tural formulations, the pounds per gallon of active Ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, prefe ably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word “Keep Out of Reach
on Front Panel Minimum Type Size of Children’
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT — The statement
“Keep Out of Reach of Children” must be located art the front
panel above the signal word except where contact with children
during distribution or use is unlikely. See Appendix IV—l.
[ 40 CFR 162.10(h)(l)(jj)]
99
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Item 7B. SIGNAL WORD — The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. See Appendix tV—i.
[ 4OCFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD “POISON” — On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word “Poison” shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear In immediate proximity to
the word POISON. See Appendix IV—l. [ 40 CFR 162.iO(h)(i)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix IV—l. [ 40 CFR 162.1O(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT — The statement “See Side
(or Back) Panel for Additional Precautionary Statements” is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
See Appendix tv—I. [ 40 CFR 162.lO(h)(l)(Iii)J
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING — The
precautionary statements listed below must appear together
on the label under the heading “PRECAUTIONARY STATEMENTS.”
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix tV—i. [ 40 CFR 162.10
(h)(2)
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. See Appendix TV—i. [ 40 CFR 162.10
(h)(2)(i)]
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 IV—l. [ 40 CFR
162. 1O(h)(2)(iI)J
100
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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 meet8 the criteria in Appendix IV—3. The require—
ment is based on the results of the flashpoint determinations
and flame extension tests required to be submitted for all
products. These statements are to be located in the side/back
panel precautionary statements section, preceded by the
heading “Physical/Chemical Hazards.” Note that no signal
word is used in conjunction with the flammability statements.
2. Criteria for declaration of non—flammability . The
following criteria will be used to determine if a product
is non—flammable:
a. A •non—flammable gas” is a gas (or mixture of gases)
that will not ignite when a lighted match is placed
against the open cylinder valve.
b. A “non—flammable liquid” is one having a flashpoint
greater than 350°F (177°C).
c. A “non—flammable aerosol” is one which meets the
following criteria:
i. The flame extension is zero inches;
Ii. There is no flashback; and
iii. The flashpoint of the non—volatile liquid
component is greater than 350°F (177°C).
3. Declaration of non—flammability . Products which
meet the criteria for non—f lammabi,li,ty çi i ed above
may bear the notation “non—flammable” or “non—flammable
(gas, liquid, etc.)” on the label. It may appear as a
substatement to the ingredients statement, or on a back
or s ide panel, but shall not be highlighted or emphasized
(as with an inordinately large type size) in any way
that may detract from precaution.
4. Other physical/chemical hazard statements . Wt 1 en
chemistry data demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such statements
may address hazards of explosivity, oxi4iztng or reducing
capability, or mi xing with o.ther substances o produce
toxic fumes.
-------
Item 9A . RESTRICTED USE CLASSIFICATION — FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard,, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section I
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active Ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency’s review of your application, your proposed classi—
fication determination will be evaluated in accordance with
the provisions of 40 CFR l 62 .ll(c). You will be notified of
the Agency’s classification decision.
Classification Labe ling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. Front panel statement of restricted use classification.
a. The statement “Restricted Use Pesticide” must
appear at the top of the front panel of the label.
The statement must be set in type of the same
minimum size as required for human hazard signal
word (see table in 40 CFR 162.10(h)(1)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if
specified in Section I). If use is restricted to
certified applicators, the following statement is
required: “For retail sale to and use only by
Certified Applicators or persons under their direct
supervision and only for those uses covered by the
Certified Applicator’s Certification.”
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
102
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a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may •split” your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B [ There is no Item 9B}.
Item 9C. MISUSE STATEMENT — All products must bear the
misuse statement, “It isa violation of Federal law to use
this product in a manner inconsistent with its labeling.”
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
Item IOA. REENTRY STATEMENT — If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83—2, March 29, 1983.
Item lOB [ There is no Item lOB].
Item lOC. STORAGE AND DISPOSAL BLOCK — All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading •Storage and Disposal” in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix
IV—4, IV—5, and IV—6 to determine the storage and disposal
instructions appropriate for your products.
Item 1OD. DIRECTIONS FOR USE — Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix IV—l. [ 40 CFR 162.10]
103
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B. Collateral Labeling
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
V. INSTRUCTIONS FOR SUBMISSION
A. For Manufacturing Products (MP) containing (Brominated
Salicylanilide) as sole active ingredient .
1. Within 90 days from receipt of this document, you must
submit to the Product Manager in the Registration Division at
the address given at the end of this section the ‘FIFRA Section
3(c)(2)(B) Summary Sheet” EPA Form 8580—1. Refer to Appendix
11—3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit protocols or modifted
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
2. Within 6 months from receipt of this document you must
submit to the Product Manager on the Registration Division:
a. Confidential Statement of Formula, EPA Form 8570—4.
b. Product Specific Data Report, EPk Form 8580—4
(Appendix 111—1).
c. Two copies of any required product—specific data
(See Tables B).
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short—term data, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section 1 (Regulatory Position and Rationale) of this
guidance document. The labeling should be either typewritten
104
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text on 8—1/2 x 11 inch paper or a mockup of the labeling
suitable for storage in 8—1/2 x 11 inch files. The draft
label must indicate the intended colors of the final label,
clear indication of the front panel label, and the intended
type sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(1)(D). Refer to 40 CFR 152.80—152.99
for latest requirements.
3. Within the times set forth in Table A , you must submit
to the Registration Division all generic data, unless you are
eligible for the formulator’s exemption. If for any reason any
test is delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
B. For Manufacturing Use Products containing (Brominated
Salicylanilide) in combination with other active ingredients
1. Within 90 days from receipt of this document, you must
submit the FIFRA Section 3(c)(2)(B) Summary Sheet,” EPA Form
8580—1. Refer to Appendix 11—3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a data
requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will he monitoring the data generated
in response to this notice. This information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
2. Within the times set forth in Table A , you must submit
to the Registration Division all generic data, unless you are
eligible for the formulator’s exemption. If for any reason any
test is delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Mont toring.
105
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C. For End Use Products containing (Brominated Salicylanilide)
alone or in combination with other active ingredients
1. Within 90 days from receipt of this document, you must
submit the “FIFRA Section 3(c)( 2 )(B) Summary Sheet,” EPA Form
8580—1. Refer to Appendix 11—3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
2. Within 6 months from receipt of this document you must
submit:
a. Confidential Statement of Formula, EPA Form 8570—4.
b. Product—Specific Data Report, EPA Form 8580—4
(Appendix 111—1), if applicable (if Table C lists required
product—specific data).
c. Two copies of any required product—specific data,
if applicable (if Table C lists required product—specific
data).
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short—term data, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. Labeling should be either typewritten
text on 8 1/2 x 11 inch paper or a mockup of the labeling
suitable for storage in 8 1/2 inch files. The draft label
must indicate the intended colors of the final label, clear
indication of the front panel label, and the intended type
sizes of the text.
3. Within the time frames set forth in Table A , submit all
generic data, unless you are eligible for the formulator’s
exempt ton.
106
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D. For intrastate products containing (Brominated Salicylanilide)
either as the sole active ingredient or in combination with
other active ingredients
These products are being called in for full Federal
registration. Producers of these products are being sent
a letter instructing them how to submit an application for
registration.
E. Addresses
Applications and other required information should be
submitted to the following address:
A. E. Castillo
Product Manager (32)
Registration Division (TS—767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW.
Washington, D.C. 20460
Phone No. (703) 557—3964
The address for submission to the Office of Compliance Monitoring
is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN—342)
Environmental Protection Agency
401 M St., SW.
Washington, D.C. 20460
107
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Appendix Il—I
Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a “study.” In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
“studies” generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by “Master Record Identifier, ” or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six—digit “Accession Number”
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine—character
temporary identifier. These entries are Listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
108
-------
Appendix lI—i (continued)
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four—digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self—explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
“received.
(2) Administrative Number. The next element,
immediately following the word “under,” is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element ts the submitter,
following the phrase “submitted by.” When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six—digit accession number follows
the symbol “CDL,” standing for “Company Data
Library.” This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456—A; the second, 123456—
B; the 26th, 123456—Z; and the 27th, 123456—AA.
109
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Appendix 11—2
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Reviewed but Found to be Non—Conclusive of the
Registration Standard Guidelines Under the Brominated
Salicylanilide Standard
00042949 Dow Chemical Company (19??). Tuasal® (Unpublished
study received on unknown date under unknown admin,
no.; CDL: 106266—A)
00043906 Hexcel Corporation (19??). Temasept It (TBS):
Composition, Manufacturing and Specifications
(Unpublished study received on September 4, 1959
under unknown admin. no.; CDL: 106241—AD)
110
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EPA REGISTRATION NO
SHEET
I DATE GUIDANCE DOCUMENT ISSUED
FIFRA section 3(C)(2)(b) notice containeo in tne ret renced
requirements. If the test procedures I will use aeviate from br are no:
in the Reports of Expert Groups to tne Cnemicals Group, OECD
use
under FIFRA section 3(C)(2)(B) ( iii to satisfy the following data
to EPA by
Agreement with Other Registrants for Development of Data’ witr
04. I request that you amend my registration by deleting the following uses (this option not available to applicants for new products)
0 5. I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products..)
REGISTRANT’S AUTHOR IZED REPRESENTATIVE SIGNATURE DATE
EPA Fo,m 8580-1 (10-82)
:iii
-------
0MB Approval 2070—0057 (expires 5/31/86)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To qualify, certIfyAj , four items) FOR DEVELOPMENT OF DATA
GUIDANCE DOCUMENT DATE
(This firm or group of firms is referred to below as “my firm” ) ——
2 My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data
1 I am duly authorized to
represent the following firm(s) w
ho are subject to the require-
ments of a Notice under
to submit c ata concernin
FIFRA Section 3(c)(2UB) contained in a Guidance Document
g the active ingredient
NAME OF FIRM
ACTIVE INGREDIENT
EPA COMPANY NUM8ER
3. My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an crbrtretion decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following date(s).
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4 My firm requests that EPA not suspend the registration(s) of my firm’s product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
Appendix 11—4
TYPED NAME SIGNATURE DATE
-------
Appendix Ill—I
PRODUCT SPECIFIC DATA REPORT
EPA Registration No. Guidance Document for_________
Date
Registration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
(For EPA Use Only)
Accession Numbers
Assigned
Citing MRIDI/
Submit-
ting
Data
(At—
tached)
§158.20
PRODUCT
CHEMISTRY
61—1
Identity of
ingredients
61—2
Statement of
composition
61—3
Discussion of
formation of
ingredients
62—1
Preliminary
analysis
62—2
CertificatIon of
limits
62—3
Analytical methods
for enforcement
limits
63—2
Color
63—3
Physical state
63—4
Odor
63—5
Melting point
63—6
Boiling point
63—7
Density, bulk—
density, or
specific_gravity
63—8
Solubility
63—9
Vapor pressure
63—10
Dissociation
constant
63—il
Octanol/water
part i t ion
coefficient
63—12
pH
113
-------
Appendix 111—1 (continued)
Registration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
(For EPA Use Only)
Accession Numbers
Assigned
Citing MRID#
Submit—
ting
Data
(At—
tached)
63—13
Stability
63—14
Oxidizing/reducing
reaction
63—15
Flammability
63—16
Explodability
63—17
Storage stability
63—18
Viscosity
63—19
Miscibility
63—20
Corrosion
characteristics
63—21
Dielectric break—
down_voltage
§158. 135
TOXICOLOGY
81—1
Acute oral LD—SO,
rat
81—2
Acute dermal
LD—50
81—3
Acute inhalation,
LC—50 rat
81—4
Primary eye
irritation, rabbit
81—5
PrImary dermal
irritation
81—6
Dertnal sensitiza—
tion
114
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APPENDIX IV —1
§ 162.10 TItle 40—Protection of Envlronrn.nt
D 162.10 Labeling requirement.
(a) Genera1—( 1) Contents of the
LabeL Every pesticide products shall
bear a label contathing the informa-
tion specified by the Act and the regu-
lations in this Part. The contents of a
label must show clearly and promi-
nently the following.
(1) The name, brand, or trademark
under which the product Is sold as pre-
scribed En paragraph (b) of this .
tion:
(ii) The name and address of the
producer, registrant, or person for
115
-------
Appendix IV-l (continued)
chopt.e I —Environmental Ps’ot.dIon Ag.ncy
whom produced as prescribed in para-
graph (C) of this section:
(ill) The net contents as prescribed
In paragraph (d) of this section:
(iv) The product registration
number a.s 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 sec-
tion;
(vii) Warning or precautionary state-
ments as prescribed In paragraph (h)
of this section:
(vtii) The directions for use as pre-
scribed in paragraph (i) of this section.
and
th) The use classification(s) as pre-
scribed in paragraph (j) of this section.
(2) ProminenCe and legibility. (i) 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 used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as Is considered necessary to
protect 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 af 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
* 162.10
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the Im-
mediate container Is enclosed within a
wrapper or outside container through
which the label cinnot 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-
talners—(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, marklnz 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 traits-
ported In a tank car, tank truck or
other mobUe or portable bulk contain-
er, a copy of the accepted libel must
be attached to the shipping papers.
and left with the consignee at the time
of delivery.
(B) Storuçe 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, shill
be securely attached to the container
in the immediate vicinity of the dis-
charge control valve.
(5) False or misleading statements.
Pursuant to section 2(QX1XA) of the
Act, a pesticide or a device declared
subject to the Act pursuant to
* 162.15. is misbranded L I its labeling Is
false or misleading In any particular
including both pesticidal and non-pea-
ticidal claims. Examples of statements
or representations In the labeling
which constitute misbranding include’
(1) A false or misleading statement
concerning the composition of the
product;
(ii) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device;
(iii) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device;
(lv) A false or misleading comparison
with other pesticides or devices.
116
-------
Appendix IV—l (continued)
§ 162.10
Title 4 0—Protection of Environment
(v) Any statement directly or indi-
rectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern.
merit;
(vi) The name of a pesticide which
contains two or more principal active
ingredients if the name suggests one
or more but not a.lJ such principal
active Ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling;
(vii) A true statement used In such a
way as to give a false or misleading im-
pression to the purchaser
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(i x) Claims as to the safety of the
pesticide or its ingredients. including
statements such as “sale,” “nonpoison-
ous.” “noninjurlous,” “harmless” or
“nontoxic to humans and pets” with
or without such a qualifying phrase as
“when used as directed”, and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) “Contains all natural ingredi-
ents”;
(B) “Among the least toxic chemi-
cals known”
(C) ‘Pollution approved”
(6) FznaZ punted iabeZtnp (1) Except
as provided in paragraph (aX6Xil) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision.
ally accepted by the Agency.
(ii) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand., or trademark. (1)
The name, brand, or trademark under
which the pesticide product Is sold
shall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which’
(i) Is false or misleading, or
(ii) has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tionai name pursuant to 162 6b 4)
(C) Name and address of producer.
registrant, or person for whom pro.
duced. An unqualified name and ad.
dre-s given on the label shall be con-
sidt red as the name and address of the
pri cucer. If the registrant’s name ap-
pears on the label and the registrant is
not the producer, or if the name of the
person for whom the pesticide was
produced appears on the label, it must
be qualified by appropriate wording
such as “Packed for ‘ ,“ “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-
tent .s (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated 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 unlt.s of fluid ounces, pints,
quarts, and gallons
(3) If the pesticide is solid or semi-
solid, viscous or pressurized, or is a
mixture of liquid and solid, the net
content statement shall be in terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be
stated in terms of the largest suitable
units, i.e., “1 pound 10 ounces” rather
than “26 ounces.”
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(6) VarIation above minimum conS
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
117
-------
Appendix IV—l (continued)
Chopt.? I_Envronmlfltol Protsctioi’ Ag.ncy
other print on that part of the label
on ‘ahich it appears and shall run par-
allel to it. The registratiOn number
and the required Identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
or endorsement of the product by the
AgencY
(f) Productn establishments regi.s-
tratzon number The producing estab-
lishment registration number preced-
ed by the phrase “EPA Est.”. of the
final establishment at which the prod-
uct a.s produced may appear in any
suitable location on the label or trnme-
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—(l) Gener-
aL The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient. the total per-
centage by weight of all inert ingredi-
ents, and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ai-
senic The active ingredients must be
designated by the term “active Ingredi-
ent.s” 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 tcteinent-
( I) The ingredier.t 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
§ 162.10
may be granted for the in.gi-edient
statement to appear elsewhere.
(ii) The text of the Ingredient state-
ment must rim parallel with other
text on the pane) on which it appears.
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names Co be u.sed 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 chemiqal
name alone shall be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless such
name has been accepted as a common
name by the AdrnlnlMratOr under the
authority of Section 25(cX6).
(4) Statements of percentapes. 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) Aceizrv .cV of stated percentapea .
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-
nil icantly must meet the following 1*-
beling requirements
1 In cases where it is determined
that a pesticide formulation changes
chemical composition significantly,
the product must bear the foUowtrtg
statement In a prominent position on
the label. ‘Not for sale or use after
(date].”
(ii) The product must meet all label
claims up to the exp 1 ration time indi-
cated on the label.
118
-------
Appendix IV—1 (continued)
§ 162.10
(7) Inert ingredients. The Adrntnts
trator may require the name of any
Inert Lngrethent(s) to be listed in the
Ingredient statement If he determines
that such ingiedienUs) may pose a
hazard to man or the environment.
(h) Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of toxicological
hazard including hazard to children,
environmental hazard, and physical or
chemical hazard fall into two groups,
those required on the front panel of
Till. 40—Protection of Environm,nt
the labeling and those which may
appear eLsewhere Specific require
ment.s concerning content, placement,
type size, and prominence are given
below.
(1) Required front panel statements,
With the exception of the child
hazard warning statement, the text re
quired on the front panel of the label
is determined by the Toxicity Catego
ry of the pesticide The category Is as
signed on the basis of the highest
hazard shown by any of the indicators
in the table below
.
I
II
ii I i v
ui 1.0,.
Up ar vO. ig 50
I 4
Fron 50 SYU 500 rrçIIQ
From 500 yi 5000 nçl
Q
Grsars. nan 5000 trç/
ha
Wtib IC ,, .
Up .2
From .2 STU 2 mg/
FrOm 2 SVU 20 n /l
G’..a rl 20 mg/
Oum I ID..
up w i ç 200
“c /h.
From 200 wvu 2000
Fr 2 000 Pwu 20000
Grsai.r nwr 20000
E T s4Ssc
Coro.,... vsS
cp y fbi
roWi 7 yi
Cor &
r, ial, TIOWi 7
iyi rT iafbn
p-’ c to’ 1 i
No T i
.fl aior
rsw 7 dsyU
No rOal n
Si ,’ iftocto
Cororwe
Sews .n abor ii 72
, ., d
Hoards rntsuon si 12 Hid o’ ligru ,matJon ii
.ii 72 tro..,s
(i) Human hczard signal word—LA)
Toxicity Category I. All pesticide prod-
uct.s meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word “Danger.” In ad.
dition if the product was assigned to
Toxicity Category I on the basis of its
oral, inhalation or derma.l toxicity (as
distinct from akin and eye local ef-
fects) the word “Poison” shall appear
in red on a background of distinctly
contrasting color and the skull and
crossbones shall appear in immediate
proximity to the word “poison.”
(B) Toxicity Category II. All pesti-
cide products meeting the criteria of
Toxicity Category II shall bear on the
front panel the signal word “Warn-
ing”
(C) Toxicity Category I II. All pesti-
cide products meeting the criteria of
Toxicity Category UI shall bear on
the front panel the signal word “Cau-
tion”
(D) Toxicity Category IV. All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word “Caution.”
(E) Use of signal word.s Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling Is necessary to pre-
vent unreasonable adverse effects on
man or the environment In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(I I) C?iLZd hazard warning Every pesO
ticide product label shall bear on the
front panel the statement “keep out of
reach of children.” Only in cases
where the likelihood of contact with
children during distribution, market-
ing. storage or use Is demonstrated by
the applicant to be extremely remote.
or if the nature of the pesticide is such
that it is approved for use on lnfant.s
or smali children. may the Adminlstra•
tol- waive this requirement.
(iii) Statement of practical treat-
ment—(A) Toxicity Category I A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall.
ing into Toxicity Category I on the
119
-------
Appendix IV—1 (continued)
Chopt.r I—Envirorim.ntaI Prot.ction Ag.ncy
basis of oral, inhalation or dermal tox-
icity The Agency may, however.
permit reasonable variations In the
placement of the statement of practi-
cal treatment is some reference such
as “See statement of practical treat-
rnent on back panel” appears on the
front panel near the word “Poison”
and the skull and crossbones
(B) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (h)(1)(ill)(A) of
this section The applicant may. how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are, however, re-
quired elsewhere on the label lit
accord with paragraph (h)(2) of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with saUl-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use The foUowing table
shoas the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
1i) Environmental hazards Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
§ 162.10
Sa. of fab.i trOflt palS WI 5 jWi
Wd ’lIS
p u
R .#Sd
al
e If
,
Ki jt
of t.aof I of
5snd.md
Ab .SIo l0
A ,totaIs
Abo,. 15 1 03 0
O Iw30
a
10
12
14
II
a
0
a
10
12
(2) Other required warnings and pre-
cautionary statement.s The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
“Precautionary Statements” and
under appropriate subheadings of
“Hazard to Humans and Domestic Ani-
mals,” “ wironmental Hazard” and
“Physical or Chemical Hazard.”
(I) Hazard to human.a and domestic
animals (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident,
injury or dAmage. The precautionary
paragraph shall be Immediately pre-
ceded by the appropriate hazard signal
word,
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
hazard and the appropriate precau-
tions to avoid potential accident,
Injury or damage. Examples of the
hazard statements and the clrcum
Toroi’y
CaIiQ y
Pr. j iiiy ilh1WIT flhI by tO y t.Q v
sj rwe,s n
sam w eye .4 1IC
I
c .I ’ (po’sonoul) 4 iwif$o sd (wvlaI.d sbioi’bsd
Cørøs,we c is lye and s am dung. ( sat
iY 4I Sil l) Do f l SIO V t 0’ W •Y
,,,tason) Do i l gr m e, or Silt 0’ On
1 1 1 .51) Do rol gal m eyes Oil Sill 0, C II c Owig
W g 0’ tS W ’e,
(Froi t pinil sIullnwll of pracXal b.sunnI ,s
o,es wndn luf HW,flt i 0’ liii I lwt Sd
,wld
(Awxnt. ?rlt sid staIrnnl r. w .d)
fl
MI y be liii if vwalio*ed (iISsd sotsd
lI’WOuSJi 54 SII ) Do rot su5Ie v s t j$t 0’
SCISy LTS,II Do ‘ UI gal I I or sAm 0’ On
Cau s (and ml milaboil 1101 QV WI lfSS
011 Sill, .51 ØO5WlQ l’(lm,tii I e,s d LAO’
0,00,811 fIll r lllansrI ‘1.5 , 10
ClOtrWIg A4xI Iluli vii 10 s t at nnta re .d I
UI
4•rmf 1 5fI (WII’JhlO 0’ 5050 ’b10 5 ’va h d l i
saIl) Avoid ‘sut11.ng 110011 ( 4I CI sy ,,v,tJ
AvOid liiC1 mdl Sill lyle 0’ dOd’Wlg 1.1 1l Of
oCIlIlCI I,r4 SIWy r,an lyes 0’ Mill mdl piSlIly If
Avoid contuci mdl sun (ayes doawig) (Apçwo-
.st Gal Ins al uflpm if r11utov I ps
ynuli wit aid siulimini ,, .d I
I V
(No p’scIuuoIwy StalalTirIts ‘SQi$Sd I
(No 0,i uXnWy St*I.rllhllI 110,Id I
120
-------
Appendix IV—l (continued)
§ 162.10
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LD.. of
100 or less, the statement “This Pesti-
cide is Toxic to Wildlife” is required.
(B) U a pesticide Intended for out-
door use contains an active ingredient
with a fish acute LC. of 1 ppm or less,
the statement “This Pesticide is Toxic
to Fish” is required.
(C) If a pesticide Intended for Out-
door use contains an active ingredient
with an avian acute oral LD.. of 100
mg/kg or less, or a subacute dietary
LC 1 . of 500 ppm or less, the statement
“This Pesticide is Toxic to Wildlife” is
required.
(D) If either accident history or field
studies demonstrate that use of the
Titi. 40—Prot.cfion of Invironm,nt
pesticide may result in fatality to
birds, fish or mammals, the statement
“This pesticide is extremely toxic to
wildlife (fish)” is required
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution ‘Keep out of lakes,
ponds or streams Do not contaminate
water by cleaning of equipment or dis-
posal of wastes.”
(UI) Physical or chemical ha.rards.
Warning statement ,s on the flammabil-
ity or explosive charactertstics of the
pesticide are required as follows
I
)A) P Uu ZtO C0ifl*i. JS
FUsI pol’ ii b 20 F i s i flur(4 3 r
z w
riui xv t O S 3 F r not — SO’ F I I 511
s . Stan IS It ç it S *W S
Sit Sins
A l ‘w isoa sd ,ns,s
£ s y a.sY. lb i Ccrt.nts ui suJs kilO a s k
e lo t$ w P sses øi s Do no pi ct,u
‘Iu E.ipos&s. o ,. I 30 F y caa.
FSnw,t ie C It.nIs v r kilO SWIP I1 PISSI
WWU wis Coin Sins Do no’ osctt. r it. l1ta,sl
Ei osas nossis.s 130’ F nta c as bsiwi
Coiflanta , osissi Do nol i as oi itois r P it oi
Do r p, tai oi w inv. 1ta 11t E t,i E
W’ .ItnI O i 130’ F ‘My csial OJi t9
(8) P40a.m 5I*urnflD Co,nAi i*
At oi is . 20’ F
Ai 20’ F s SO’ F ——
Abe ,. SO’ F wd r ISO’ F -
£gna !VM5it K.sç SWay fret’ t sits b tWitSd
FI.. ka y Pet It I I w Coin Sit’s
i t I t Sims
(i) Dtreetions for Use—( 1) General
reqissrements—(i) Adeq,.iacii and cZar-
fly qf directions. Directions for use
must be stated In terms which can be
easily read and understood by the av-
erage person likely to use or’ to super-
vise the use of the pesticide. When fol-
lowed., directions must be adequate to
protect the public from fraud and
from personal injury and to prevent
unreasonable adverse effects on the
environment.
(U) Placement qf directions for use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that
(A) If required by the Agency, such
printed or graphic matter is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag:
(B) The label bears a reference to
the directions for use in accompanying
leaflets or circular’s, such as “See di-
rections In the enclosed circular” and
(C) The Administrator determines
that it is not necessary for such direc-
Uons to appear on the label.
(Ui) Exceptions to requirement for
direction for use—(A) Detailed direc-
tions for use may be omitted from la-
beling of pesttcides which are intended
121
-------
Appendix IV—1 (continued)
Chapter I—Environm.ntal Protection A 9 .ncy
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes.
provided that:
1 The label clearly shows that the
product is intended for use only In
manufacturing processes and specifies
the type(s) of products involved.
(2) Adequate information such as
technical data sheets or bulletins, Is
available to the trade specifying the
type of product Involved and its
proper use in manufacturing process-
es.
(3) The product will not come into
the hands of the general public except
alter 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:
(1) The label clearly states that the
product Is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse 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 which are intended for
use only by formulators 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 states that the
product is intended for use only in
manufacturing, formulating, mixing.
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod.
ucts involved:
(3) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered, and
§ 62 .1O
(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.”
(lii) 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 assøciated 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
re”ults without causing unreasonable
adverse effects on the environment.
(vlll) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requfrementa
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 CTh Part 165. These
Instructions shall be grouped and
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 162.10(hXl)(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]
122
-------
Appendix IV—1 (continued)
§ 162.11
(E) For restricted use pesticides. a
statement that the pesticide may be
applied under the direct supervision of
a certified appilcator who Is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who Is physically present
(F) Other pertinent Information
which the Admint trator det y jy
to be necessary for the protection of
man and the environment.
(j) Statement of Use C’Za slfication.
By October 22, 1976, all pesticide prod-
ucts must bear on their labels a state-
ment of use elassiflcation as described
In paragraphs (j)(1) and (2) of this sec-
tion. Any pesticide product for which
some uses are classified for general use
and others for restricted use shall be
separately Labeled according to the La-
beling standards set forth in this sub-
section, and shall be marketed as sepa-
rate products with different registra-
tion numbers, one bearing directions
only for general use(s) and the other
bearing directions f or restricted use(s)
except that. if a product has both re-
stricted use(s) and general use(s), both
of these uses may appear on a product
Labeled for restricted use Such prod-
ucts shall be subject to the provisions
of 162.1O(j)(2).
(1) General Tue Classification. Pesti-
cide products bearing directions for
use(s) e1s . sified general shall be 1*.
beled with the exact words “General
Classification” immediately below the
heading “Directions for Use.” And ref-
erence to the general Lw11ication
that suggests or impfles that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tithed In the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of misbranding.
(2) Restricted Use Clautficatlon ,
Pesticide products bearing direction
for use(s) classified restricted shall
bear statements of restricted use cLas-
sification on the front panel as de-
scribed below:
(I) Front panel stafement of restrict-
ed use c i asificatlcn, (A) At the top of
the front panel of the label, set in type
This 40—Prot.ctlon of Erivironmsni
of the same mimmuin sizes as required
for human hazard signal words (see
table in I 162.1O(h)(l) 1v)), and appear-
lug with sufficient prominence relative
to other text and graphic material on
the front panel to make It unlikely to
be overlooked under customary condi-
tions of purchase and use, the state-
ment “Restricted Use Pesticide” shall
appear.
(B) Directly below this statement on
the front panel, a summary statement
of the terms of restriction Imposed as
a precondition to registration shall
appear. If use Is restricted to certified
applicators, the following statement is
required. ‘For retail sale to and use
only by Certified Applicators or per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator’s certification.” If.
however, other regulatory restrictions
are imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertising. (Reserved)
140 FR 28265. July 3. 1975. 40 FR 32329.
Aug 1, 1975, 40 FR 36571, Aug 21. 1975. as
amended at 43 FR 5786. Feb V. 1918)
123
-------
Appendix 1V2
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
LABEL ELEMENT
APPLICABILITY
OF REQUIREMENT
PLACEMENT ON LABEL
COMMENTS
REQUIRED
PREFERRED
1
Product name
All products
Front panel
Center front
panel
2
Company name
and address
All products
None
Bottom front
panel or end
of label text
If registrant Is not the producer, must
be qualified by “Packed for . . .,“
“Distributed by. . .,“ etc.
3
Net contents
All products
None
‘
Bottom front
panel or end
of_label_text
May be in metric units In addition to
U.S. units
4
EPA Reg. No.
All products
None
Front panel
Must be in similar type size and run
parallel_to_other_type.
5
EPA Est. No.
-
All products
None
Front panel,
immediately
before or
fol lowing
Reg. No.
May appear on the container instead of
the label.
6A
Ingredients
statement
All products
Front panel
Immediately
following
product_name
Text must run parallel with other text
on the panel.
6B
Pounds/gallon
statement
Liquid products
where dosage
given as lbs.
ai/unit area
Front panel
Directly below
the main
ingredients
statement
7
Front panel
precautionary
statements
All products
Front panel
All front panel precautionary statements
must be grouped together, preferably
blocked.
7A
Keep Out of Reach
of Children
(Child hazard
warning)
All products
Front panel
Above signal
word
Note type size requirements.
7B
Signal word
All products
Front panel
Immediately
below child
hazard
warning
Note type size requirements.
‘.24
-------
Appendix IV—2 (continued)
ITEM
LABEL ELEMENT
APPLICABILITy
OF REQUIREMENT
PLACEMENT ON LABEL
REQUIRED
PREFERRED
7C
Skull & cross—
bones and word
POISON (in red)
All products
which are Cat—
egory I based
on oral, der—
mal, or inhala-
tion_toxicity
Front panel
Both in close
proximity to
signal word
COMMENTS
7D
Statement of
practical
treatment
All products
in Categories
I, It, and III
Category I:
Front panel
unless refer-
ral statement
i8 used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
for all.
7E
Referral
statement
All products
where pre-
cautionary
labeling
appears on
other than
front_panel.
Front panel
8
Side/back panel
precautionary
statements
All products
None
Top or side
of back panel
preceding
directions
for
Must be grouped under the headings in
8A, 88, and 8C; preferably blocked.
8A
Hazards to
humans and
domestic
an I ma ls
All products
in Categories
I, II, and III
None
use
Same as above
Must be preceded by appropriate signal
word.
8B
Environmental
hazards
All products
None
Same as above
Environmental hazards include bee
125
-------
Appendix IV—2 (continued)
ITEM
LABEL ELEMENT
APPLICABILITY
OF REQUIREMENT
PLACEMENT ON lABEL
COMMENTS
REQUIRED
PREFERRED
8C
Physical or
chemical
hazards
All pressurized
products, others
with flash
points under
150°F
None
Same as above
9A
Restricted
block
All restricted
products
Top center
of front
panel
Preferably
blocked
Includes a statement of the terms of
restriction. The words RESTRICTED USE
PESTICIDE” must be same type size as
signal_word.
9C
Misuse
statement
All products
Immediately
following
heading of
directions
for use
lOA
Reentry
statement
,
All
cholinesterase
inhibitors
In the
directions
for use
Immediately
after misuse
statement
1OC
Storage and
disposal block
All products
In the
directions
for use
Immediately
before
specific
directions
for use or
at the end of
directions
for_use
Must be set apart and clearly distin—
guishable from from other directions
for use.
lOD
Directions
for_use
All products
None
None
May be in metric as well as U.S. units
-------
Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
Required Label Statement
I. Pressurized Containers
A. 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. Flashpolnt above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
127
-------
Appendix IV—4
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading :
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.”
Storage Instructions :
All product labels are required to have appropriate storage
instructions. Specific storage Instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do If the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross—contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
128
-------
Appendix IV—5
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.”
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 inhalation toxicity
must bear the followipg 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 he
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.”
3. 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 meet any of
the criteria in 40 CFR 261, Subpart C for a hazardous waste
must bear the following pesticide disposal statement:
“Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance.”
4. 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.••
5. 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.”
129
-------
Appendix IV—5
(continued)
Pesticides that are hazardous wastes under 40 CFR 2 61.33(e) and (f)
when discarded.
“ Acutely Hazardous” Commercial Pesticides (RCRA “E” List)
Active Ingredients :
Ac role in
Aldicarb
Aidrin
Allyl alcohol
Aluminum phosphide
4—Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p—Chloroani line
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2—Cyclohexyl—4,6—dinitropheno].
Dieldrln
0, 0—Diethyl S— [ 2—ethylthio)ethylj phosphorodithioate
(disulfoton, Di—Syston)
0,0—Diethyl 0—pyrazirtyl phosphorothioate (Zinophos)
Dime t hoa t e
0,0—Dimethyl 0—p—nitrophenyl phosphorothloate (methyl parathion)
4 ,6—Dinitro—o—cresol and salts
4 ,6—Dinitro--o—cyclohexylpheno].
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endotha 11
Endrin
Fatnphur
Fluoroace tamide
Hep t achlo r
Hexane thy 1 tet raphosphate
Hydrocyanic acid
Hydrogen cyanide
Me thornyl
alpha—Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
130
-------
Appendix IV—5
(continued)
“ Acutely Hazardous” Commercial Pesticides (RCRA E” List)
Active Ingredients continued :
Phenylmercuric acetate (PMA)
Phora te
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0, 0—Tetraethy]. di thiopyrophospha te (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarjn
Zinc phosphide
131
-------
Appendix IV—5
(continued)
“ Toxic” Commercial Pesticide Products (RCRA “F” List)
Active Ingredients :
Acetone
Acrylonitri le
Am i t to 1 e
Benzene
Bis(2—ethylhexy l)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chiordane (technical)
Chlo robenzene
4—C h 1. or o — in—cr e s ol
Chloroform
o—Chlorophenol
4—Chlo ro—o—t oluidine hydrochloride
Creosote
Cresylic acid
Cyc lohexane
Decachlorooctahydro—l,3,4—metheno—2H—cyclobuta [ c,dJ--penta len—2—one
(kepone, chiordecone)
1, 2—Dibromo—3—chloropropane (DBCP)
Dibutyl phthalate
S—3,3—(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o—Dichlorobe nzene
p—Di ch lo ro benz ene
Dichiorod i fluoromethane (Freon 12 a)
3, 5—Dichloro—N--(l, 1—dimethyl—2—propynyl) benzamide (pronamide,Kerb)
Dichioro diphenyl dichioroethane (DDD)
Dichioro diphenyl trichioroethane (DDT)
Dichiorethyl ether
2,4—Dichlorophenoxyacetic, esters and salts (2,4—D)
1,2—Dichloropropane
1,3—Dichioropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4’—dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexach lorobenzene
Hexachlorocycl opentadiene
Hexachloroethane
Hydrofluoric acid
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Appendix IV—5
(continued)
•Toxic” Commercial Pesticide Products (RCRA “F” List)
Active Ingredients continued :
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Me rcury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2 ‘—Methylenebis (3,4, 6—trlchlorophenol) (hexachiorophene)
Methylene chloride
Methyl ethyl ketone
4—Methyl—2—pentanone (methyl Isobutyl ketone)
Naphthalene
NIt robenzene
p—Ni trophenol
Pentachlo roethane
Pentachloroni trobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0—diethyl, methyl ester
Propylene dlchloride
Pyridine
Resorcino].
Saf role
Selenium disulfide
SI ivex
1,2,4, 5—Tetrachiorobeazene
1, 1, 2, 2—Tetrachioroethane
Tetrachioroethylene
2, 3, 4, 6—Tet rachiorophenol
Thi ram
Toluene
1,1, 1—Trichioroethane
Trichioroet hylene
Trichioromonofluoromethane (Freon il®)
2,4, 5—Trichiorophenol
2,4, 6—Trichlorophenol
2, 4 ,5—Trichlorophenoxyacetic acid (2,4,5—T)
Xylene
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Appendix IV—5
(continued)
“ Toxic” Commercial Pesticide Products (RCRA “F” List)
Inert Ingredients :
Acetone
Ace toni t rile
Ace tophenone
Acrylic acid
Aniline
Benz ene
Chlorobenzene
Chloroform
Cyc lohexane
Cyclohexanone
Dichiorodifluoromethane (Freon 12 )
Diethyl phthalate
Dime thy lamine
Dimethyl phthalate
1, 4—Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl me thacrylate
Naphthalene
Saccharin and salts
Thi ourea
Toluene
1 ,1,1—Trichioroethane
1,1, 2—Trichioroethane
Trichiorofluoromethane (Freo 11 )
Vinyl chloride
Xylene
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Appendix IV—6
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Non—aerosol products
(bottles, cans, jars)
Do not reuse container (bottle, can, jar).
Rinse thoroughly before
Non—aerosol products
(bags)
discarding in trash.
Do not reuse bag. Discard bag in trash.
Aerosol products
Replace cap and discard containers in
trash. Do not incinerate
2. All other products must bear container disposal instructions,
based on container type, listed below:
1/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
Container TyDe Statement
Metal
containers
(non—aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfUl, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and
Fiber drums
with liners
procedures.
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’, of
Paper and
plastic bags
the same manner.
Completely empty bag into ‘plication
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Compressed gas
çylinders
—
Return empty cylinder for reuse (or
similar wording)
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