ICR Attachment B - Labeling Requirements for Pesticides and Devices (40 CFR 156.10)

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ICR Attachment B - Labeling Requirements for Pesticides and Devices (40 CFR 156.10)

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Environmental Protection Agency

§ 156.10

156.78 Precautionary statements for physical or chemical hazards.

(vi) An ingredient statement as prescribed in paragraph (g) of this section;
(vii) Hazard and precautionary statements as prescribed in subpart D of
this part for human and domestic animal hazards and subpart E of this part
for environmental hazards.
(viii) The directions for use as prescribed in paragraph (i) of this section;
and
(ix) The use classification(s) as prescribed in paragraph (j) of this section.
(2) Prominence and legibility. (i) All
words, statements, graphic representations, designs or other information required 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 customary
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 applied equally to both the English and
other-language versions of the labeling.
(4) Placement of Label—(i) General.
The label shall appear on or be securely
attached to the immediate container of
the pesticide product. For purposes of
this section, and the misbranding provisions of the Act, ‘‘securely attached’’
shall mean that a label can reasonably
be expected to remain affixed during
the foreseeable conditions and period
of use. If the immediate container is
enclosed within a wrapper or outside
container through which the label cannot be clearly read, the label must also
be securely attached to such outside
wrapper or container, if it is a part of

Subpart E—Environmental Hazard and
Precautionary Statements
156.80
156.85

General.
Non-target organisms.

Subparts F–G [Reserved]
Subpart H—Container Labeling
156.140 Identification of container types.
156.144 Residue removal instructions—general.
156.146 Residue removal instructions for
nonrefillable
containers—rigid
containers with dilutable pesticides.
156.156 Residue removal instructions for refillable containers.
156.159 Compliance date.

Subparts I–J [Reserved]
Subpart K—Worker Protection Statements
156.200 Scope and applicability.
156.203 Definitions.
156.204 Modification and waiver of requirements.
156.206 General statements.
156.208 Restricted-entry statements.
156.210 Notification-to-workers statements.
156.212 Personal
protective
equipment
statements.
AUTHORITY: 7 U.S.C. 136–136y.

Subpart A—General Provisions
§ 156.10 Labeling requirements.
(a) General—(1) Contents of the label.
Every pesticide product shall bear a
label containing the information specified by the Act and the regulations in
this part. The contents of a label must
show clearly and prominently the following:
(i) The name, brand, or trademark
under which the product is sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or person for whom
produced as prescribed in paragraph (c)
of this section;
(iii) The net contents as prescribed in
paragraph (d) of this section;
(iv) The product registration number
as prescribed in paragraph (e) of this
section;
(v) The producing establishment
number as prescribed in paragraph (f)
of this section;

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§ 156.10

40 CFR Ch. I (7–1–07 Edition)

the package as customarily distributed
or sold.
(ii) Tank cars and other bulk containers—(A) Transportation. While a pesticide product is in transit, the appropriate provisions of 49 CFR parts 170–
189, concerning the transportation of
hazardous materials, and specifically
those provisions concerning the labeling, marking and placarding of hazardous materials and the vehicles carrying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is transported in a tank car, tank truck or
other mobile or portable bulk container, a copy of the accepted label
must be attached to the shipping papers, and left with the consignee at the
time of delivery.
(B) Storage. When pesticide products
are stored in bulk containers, whether
mobile or stationary, which remain in
the custody of the user, a copy of the
label of labeling, including all appropriate directions for use, shall be securely attached to the container in the
immediate vicinity of the discharge
control valve.
(5) False or misleading statements. Pursuant to section 2(q)(1)(A) of the Act, a
pesticide or a device declared subject
to the Act pursuant to § 152.500, is misbranded if its labeling is false or misleading in any particular including
both pesticidal and non-pesticidal
claims. Examples of statements or representations in the labeling which constitute misbranding include:
(i) A false or misleading statement
concerning the composition of the
product;
(ii) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device;
(iii) A false or misleading statement
about the value of the product for purposes other than as a pesticide or device;
(iv) A false or misleading comparison
with other pesticides or devices;
(v) Any statement directly or indirectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Government;
(vi) The name of a pesticide which
contains two or more principal active
ingredients if the name suggests one or
more but not all such principal active

ingredients even though the names of
the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a
way as to give a false or misleading impression to the purchaser;
(viii) Label disclaimers which negate
or detract from labeling statements required under the Act and these regulations;
(ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as ‘‘safe,’’ ‘‘nonpoisonous,’’ ‘‘noninjurious,’’ ‘‘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 comparative statements on the safety of the
product, including but not limited to:
(A) ‘‘Contains all natural ingredients’’;
(B) ‘‘Among the least toxic chemicals
known’’
(C) ‘‘Pollution approved’’
(6) Final printed labeling. (i) Except as
provided in paragraph (a)(6)(ii) 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 provisionally accepted by the Agency.
(ii) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silkscreened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of microfilm 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 additional name pursuant to § 152.132.
(c) Name and address of producer,
registrant, or person for whom produced. An unqualified name and address given on the label shall be considered as the name and address of the
producer. If the registrant’s name appears on the label and the registrant is

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Environmental Protection Agency

§ 156.10

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 * * *,’’ ‘‘Distributed by
* * *,’’ or ‘‘Sold by * * *’’ to show that
the name is not that of the producer.
(d) Net weight or measure of contents.
(1) The net weight or measure of content shall be exclusive of wrappers or
other materials and shall be the average content unless explicitly stated as
a minimum quantity.
(2) If the pesticide is a liquid, the net
content statement shall be in terms of
liquid measure at 68 °F (20 °C) and shall
be expressed in conventional American
units of fluid ounces, pints, quarts, and
gallons.
(3) If the pesticide is solid or semisolid, 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 expressed
in metric units.
(6) Variation above minimum content
or around an average is permissible
only to the extent that it represents
deviation unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In
no case shall the average content of
the packages in a shipment fall below
the stated average content.
(7) For a pesticide product packaged
in a refillable container, an appropriately sized area on the label may be
left blank to allow the net weight or
measure of content to be marked in by
the refiller according to 40 CFR
165.65(h) or 165.70(i) prior to distribution or sale of the pesticide. As required in paragraph (a)(1)(iii) of this
section, the net contents must be
shown clearly and prominently on the
label.
(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 Registration
No.,’’ or the phrase ‘‘EPA Reg. No.’’

The registration number shall be set in
type of a size and style similar to other
print on that part of the label on which
it appears and shall run parallel to it.
The registration number and the required identifying phrase shall not appear in such a manner as to suggest or
imply recommendation or endorsement
of the product by the Agency.
(f) Producing establishment’s registration number. The producing establishment registration number preceded by
the phrase ‘‘EPA Est.’’, of the final establishment at which the product was
produced may appear in any suitable
location on the label or immediate container. It must appear on the wrapper
or outside container of the package if
the EPA establishment registration
number on the immediate container
cannot be clearly read through such
wrapper or container. For a pesticide
product packaged in a refillable container, an appropriately sized area on
the label may be left blank after the
phrase ‘‘EPA Est.’’ to allow the EPA
establishment registration number to
be marked in by the refiller according
to 40 CFR 165.65(h) or 165.70(i) prior to
distribution or sale of the pesticide.
(g) Ingredient statement—(1) General.
The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total percentage by weight of all inert ingredients; and if the pesticide contains arsenic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental arsenic. The active ingredients must be
designated by the term ‘‘active ingredients’’ and the inert ingredients by the
term ‘‘inert ingredients,’’ or the singular forms of these terms when appropriate. 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 contain 100 percent active ingredients. Unless the ingredient statement is a complete analysis of the pesticide, the
term ‘‘analysis’’ shall not be used as a
heading for the ingredient statement.
(2) Position of ingredient statement. (i)
The ingredient statement is normally
required on the front panel of the label.
If there is an outside container or

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§ 156.10

40 CFR Ch. I (7–1–07 Edition)

wrapper through which the ingredient
statement cannot be clearly read, the
ingredient statement must also appear
on such outside container or wrapper.
If the size or form of the package
makes it impracticable to place the ingredient statement on the front panel
of the label, permission may be granted
for the ingredient statement to appear
elsewhere.
(ii) The text of the ingredient statement must run parallel with other text
on the panel on which it appears, and
must be clearly distinguishable from
and must not be placed in the body of
other text.
(3) Names to be used in ingredient statement. The name used for each ingredient shall be the accepted common
name, if there is one, followed by the
chemical name. The common name
may be used alone only if it is well
known. If no common name has been
established, the chemical name alone
shall be used. In no case will the use of
a trademark or proprietary name be
permitted unless such name has been
accepted as a common name by the Administrator under the authority of section 25(c)(6).
(4) Statements of percentages. The percentages of ingredients shall be stated
in terms of weight-to-weight. The sum
of percentages of the active and the
inert ingredients shall be 100. Percentages shall not be expressed by a range
of values such as ‘‘22–25%.’’ If the uses
of the pesticide product are expressed
as weight of active ingredient per unit
area, a statement of the weight of active ingredient per unit volume of the
pesticide formulation shall also appear
in the ingredient statement.
(5) Accuracy of stated percentages. The
percentages given shall be as precise as
possible reflecting good manufacturing
practice. If there may be unavoidable
variation
between
manufacturing
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 significantly must meet the following labeling requirements:
(i) In cases where it is determined
that a pesticide formulation changes
chemical composition significantly,
the product must bear the following

statement in a prominent position on
the label: ‘‘Not for sale or use after
[date].’’
(ii) The product must meet all label
claims up to the expiration time indicated on the label.
(7) Inert ingredients. The Administrator may require the name of any
inert ingredient(s) to be listed in the
ingredient statement if he determines
that such ingredient(s) may pose a hazard to man or the environment.
(h) [Reserved]
(i) Directions for Use—(1) General requirements—(i) Adequacy and clarity of
directions. 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.
(ii) Placement of 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 accompanies
the pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter is securely
attached to each package of the pesticide, or placed within the outside
wrapper or bag;
(B) The label bears a reference to the
directions for use in accompanying
leaflets or circulars, such as ‘‘See directions in the enclosed circular:’’ and
(C) The Administrator determines
that it is not necessary for such directions to appear on the label.
(iii) Exceptions to requirement for direction for use. (A) Detailed directions for
use may be omitted from labeling of
pesticides which are intended for use
only by manufacturers of products
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

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Environmental Protection Agency

§ 156.10

available to the trade specifying the
type of product involved and its proper
use in manufacturing processes;
(3) The product will not come into
the hands of the general public except
after incorporation into finished products; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse effects
on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesticide products for which sale is limited to physicians, veterinarians, or
druggists, 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 effects
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 pesticide products which are intended for
use only by formulators in preparing
pesticides for sale to the public, provided 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 products involved;
(3) The product as finally manufactured, formulated, mixed, or repackaged is registered; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse effects
on man or the environment.
(2) Contents of Directions for Use. The
directions for use shall include the following, under the headings ‘‘Directions
for Use’’:
(i) The statement of use classification as prescribed in paragraph (j) of
this section immediately under the
heading ‘‘Directions for Use.’’

(ii) Immediately below the statement
of use classification, the statement ‘‘It
is a violation of Federal law to use this
product in a manner inconsistent with
its labeling.’’
(iii) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vi) The method of application, including instructions for dilution, if required, and type(s) of application apparatus or equipment required.
(vii) The frequency and timing of applications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(viii) Worker protection statements
meeting the requirements of subpart K
of this part.
(ix) Specific directions concerning
the storage, residue removal and disposal of the pesticide and its container,
in accordance with subpart H of this
part and part 165 of this chapter. These
instructions must 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 warning.
(See table in § 156.60(b))
(x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects, such as:
(A) Required intervals between application 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) For total release foggers as defined in paragraph (h)(2)(iii)(B) of this
section, the following statements must
be included in the ‘‘Directions for
Use’’:
DO NOT use more than one fogger per
room. DO NOT use in small, enclosed spaces
such as closets, cabinets, or under counters
or tables. Do not use in a room 5 ft.×5 ft. or
smaller; instead, allow fog to enter from
other rooms. Turn off ALL ignition sources
such as pilot lights (shut off gas valves),
other open flames, or running electrical appliances that cycle off and on (i.e., refrigerators, thermostats, etc.). Call your gas

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§ 156.60

40 CFR Ch. I (7–1–07 Edition)

utility or management company if you need
assistance with your pilot lights.’’

(i) Front panel statement of restricted
use classification. (A) At the top of the
front panel of the label, set in type of
the same minimum sizes as required
for human hazard signal words (see
table in paragraph (h)(1)(iv) of this section), and appearing with sufficient
prominence relative to other text and
graphic material on the front panel to
make it unlikely to be overlooked
under customary conditions of purchase and use, the statement ‘‘Restricted Use Pesticide’’ shall appear.
(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 persons under their direct supervision and
only for those uses covered by the Certified Applicator’s certification.’’ If,
however, other regulatory restrictions
are imposed, the Administrator will define the appropriate wording for the
terms of restriction by regulation.

(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not physically 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 applicator who is physically present.
(F) Other pertinent information
which the Administrator determines to
be necessary for the protection of man
and the environment.
(j) Statement of Use Classification. By
October 22, 1976, all pesticide products
must bear on their labels a statement
of use classification as described in
paragraphs (j) (1) and (2) of this section. Any pesticide product for which
some uses are classified for general use
and others for restricted use shall be
separately labeled according to the labeling standards set forth in this subsection, and shall be marketed as separate products with different registration numbers, one bearing directions
only for general use(s) and the other
bearing directions for restricted use(s)
except that, if a product has both restricted use(s) and general use(s), both
of these uses may appear on a product
labeled for restricted use. Such products shall be subject to the provisions
of paragraph (j)(2) of this section.
(1) General Use Classification. Pesticide products bearing directions for
use(s) classified general shall be labeled with the exact words ‘‘General
Classification’’ immediately below the
heading ‘‘Directions for Use.’’ And reference to the general classification
that suggests or implies that the general utility of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading statement
under the statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing direction for
use(s) classified restricted shall bear
statements of restricted use classification on the front panel as described
below:

[40 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1,
1975; 40 FR 36571, Aug. 21, 1975, as amended at
43 FR 5786, Feb. 9, 1978. Redesignated and
amended at 53 FR 15991, 15999, May 4, 1988; 57
FR 38146, Aug. 21, 1992; 60 FR 32096, June 19,
1995; 63 FR 9082, Feb. 23, 1998; 66 FR 64764,
Dec. 14, 2001; 71 FR 47420, Aug. 16, 2006]

Subparts B–C [Reserved]
Subpart D—Human Hazard and
Precautionary Statements
SOURCE: 66 FR 64764, Dec. 14, 2001, unless
otherwise noted.

§ 156.60 General.
Each product label is required to bear
hazard and precautionary statements
for humans and domestic animals (if
applicable) as prescribed in this subpart. Hazard statements describe the
type of hazard that may occur, while
precautionary statements will either
direct or inform the user of actions to
take to avoid the hazard or mitigate
its effects.
(a) Location of statements—(1) Front
panel statements. The signal word, child
hazard warning, and, in certain cases,
the first aid statement are required to

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File Typeapplication/pdf
File TitleDocument
SubjectExtracted Pages
AuthorU.S. Government Printing Office
File Modified2007-10-02
File Created2007-10-02

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