[Code of Federal Regulations]
[Title 40, Volume 21]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR156.10]

[Page 56-61]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 156--LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 156.10  Labeling requirements.


    (a) General--(1) Contents of the label. Every pesticide products 
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;
    (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 the package as customarily distributed or sold.

[[Page 57]]

    (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 Sec. 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 silk-screened 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 
Sec. 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 not the producer, or if 
the name of the

[[Page 58]]

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  deg.F (20  deg.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.
    (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 establishments 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.
    (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 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

[[Page 59]]

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 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

[[Page 60]]

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 and disposal of the 
pesticide and its container, meeting the requirements of 40 CFR 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 warning. (See table in 
Sec. 162.10(h)(1)(iv))
    (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.x5 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 utility or management company if you need 
assistance with your pilot lights.''

    (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

[[Page 61]]

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:
    (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.

[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]

Subparts B-C [Reserved]