40 CFR § 156.10 - Labeling requirements.

§ 156.10 Labeling requirements.

(a) General -

(1) Contents of the label. Every shall bear a label the information specified by the 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 is sold as prescribed in paragraph (b) of this section;

(ii) The name and address of the producer, registrant, or for whom as prescribed in paragraph (c) of this section;

(iii) The net contents as prescribed in of this section;

(iv) The registration number as prescribed in of this section;

(v) The producing establishment number as prescribed in of this section;

(vi) An statement as prescribed in of this section;

(vii) Hazard and precautionary statements as prescribed in of this part for human and domestic animal hazards and of this part for environmental hazards.

(viii) The directions for use as prescribed in of this section; and

(ix) The use classification(s) as prescribed in of this section.

(2) Prominence and legibility.

(i) All words, statements, graphic representations, designs or other information required on the labeling by the or the regulations in this part must be clearly legible to a 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 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 of the . For purposes of this section, and the misbranding provisions of the, “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 is enclosed within a wrapper or outside through which the label cannot be clearly read, the label must also be securely attached to such outside wrapper or , if it is a part of the package as customarily distributed or sold.

(ii) Tank cars and other bulk containers -

(A) Transportation. While a is in , the appropriate provisions of CFR parts -, concerning the 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 is transported in a car, truck or other mobiles or portable bulk , 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 are stored in bulk , whether mobiles 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 in the immediate vicinity of the valve.

(5) False or misleading statements. Pursuant to section 2(q)(1)(A) of the , a or a device declared subject to the 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 ;

(ii) A false or misleading statement concerning the effectiveness of the as a or device;

(iii) A false or misleading statement about the value of the for purposes other than as a or device;

(iv) A false or misleading comparison with other or devices;

(v) Any statement directly or indirectly implying that the or device is recommended or endorsed by any of the Federal Government;

(vi) The name of a which two or more principal active if the name suggests one or more but not all such principal active even though the names of the other are 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 and these regulations;

(ix) Claims as to the safety of the 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 , 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 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 .

(ii) Clearly legible reproductions or photo reductions will be accepted for unusual labels such as those silk-screened directly onto glass or metal 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 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 through registration or supplemental registration as an additional name pursuant to § 152.132.

(c) Name and address of producer, registrant, or 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 for whom the was 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 as a quantity.

(2) If the 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 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 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 content or around an average is permissible only to the extent that it represents deviation unavoidable in good manufacturing practice. Variation below a stated is not permitted. In no case shall the average content of the packages in a shipment fall below the average content.

(7) For a packaged in a refillable , 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 CFR or prior to distribution or sale of the. As required in 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 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 by the .

(f) Producing establishment's registration number. The producing establishment registration number preceded by the phrase “EPA Est.”, of the final establishment at which the was may appear in any suitable locations on the label or immediate . It must appear on the wrapper or outside of the package if the establishment registration number on the immediate cannot be clearly read through such wrapper or. For a packaged in a refillable , an appropriately sized area on the label may be left blank after the phrase “EPA Est.” to allow the establishment registration number to be marked in by the refiller according to CFR or prior to distribution or sale of the .

(g) Ingredient statement -

(1) General. The label of each must bear a statement which the name and percentage by weight of each active , the total percentage by weight of all inert ingredients; and if the arsenic in any form, a statement of the percentages of total and water-soluble arsenic calculated as elemental arsenic. The active must be designated by the term “active ” and the inert by the term “inert ,” 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 , none” is not required for which contain 100 percent active . Unless the statement is a complete analysis of the, the term “analysis” shall not be used as a heading for the statement.

(2) Position of ingredient statement.

(i) The statement is normally required on the front panel of the label. If there is an outside or wrapper through which the statement cannot be clearly read, the statement must also appear on such outside or wrapper. If the size or form of the package makes it impracticable to place the statement on the front panel of the label, permission may be granted for the statement to appear elsewhere.

(ii) The text of the 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 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 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 under the authority of section 25(c)(6).

(4) Statements of percentages. The percentages of shall be in terms of weight-to-weight. The sum of percentages of the active and the inert shall be 100. Percentages shall not be expressed by a range of values such as “22-25%.” If the uses of the are expressed as weight of active per unit area, a statement of the weight of active per unit volume of the formulation shall also appear in the 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 for each active shall be the lowest percentage which may be present.

(6) Deterioration. which change in chemical composition significantly must meet the following labeling requirements:

(i) In cases where it is determined that a formulation changes chemical composition significantly, the must bear the following statement in a prominent position on the label: “Not for sale or use after [date].”

(ii) The must meet all label claims up to the expiration time indicated on the label.

(7) Inert ingredients. The may require the name of any inert ingredient(s) to be listed in the 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 in terms which can be easily read and understood by the average likely to use or to supervise the use of the . 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 . Directions for use may appear on printed or graphic matter which accompanies the provided that:

(A) If required by the , such printed or graphic matter is securely attached to each package of the , 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 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 which are intended for use only by of other than in their regular manufacturing processes, provided that:

(1) The label clearly shows that the is intended for use only in manufacturing and specifies the type(s) of involved.

(2) Adequate information such as technical data sheets or bulletins, is available to the trade specifying the type of involved and its proper use in manufacturing processes;

(3) The will not come into the hands of the general public except after incorporation into finished products; and

(4) The 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 for which sale is limited to physicians, veterinarians, or druggists, provided that:

(1) The label clearly that the is for use only by physicians or veterinarians;

(2) The determines that such directions are not necessary to prevent unreasonable adverse effects on man or the environment; and

(3) The is also a drug and regulated under the provisions of the Federal Food, Drug and Cosmetic .

(C) Detailed directions for use may be omitted from the labeling of which are intended for use only by formulators in preparing 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 for purposes;

(2) The label clearly that the is intended for use only in manufacturing, formulating, mixing, or repacking for use as a and specifies the type(s) of involved;

(3) The as finally , formulated, mixed, or repackaged is registered; and

(4) The 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 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 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 .

(v) The dosage rate associated with each 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 of this part.

(ix) Specific directions concerning the , residue removal and of the and its , in accordance with of this part. These instructions must be grouped and appear under the heading, “Storage and .” This heading must be set in type of the same 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 , 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 that cycle off and on (i.e., refrigerators, thermostats, etc.). Call your gas utility or company if you need assistance with your pilot lights.”

(E) For restricted use , a statement that the may be applied under the direct supervision of a certified who is not physically present at the of application but nonetheless available to the applying the , unless the has determined that the may only be applied under the direct supervision of a certified who is physically present.

(F) Other pertinent information which the determines to be necessary for the protection of man and the environment.

(j) Statement of use classification. Any for which some uses are classified for general use and others for restricted use shall be separately labeled according to the labeling set forth in this subsection, and shall be marketed as separate 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 has both restricted use(s) and general use(s), both of these uses may appear on a labeled for restricted use. Such shall be subject to the provisions of of this section.

(1) General Use Classification. 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 extends beyond those purposes and uses in the Directions for Use will be considered a false or misleading statement under the statutory definitions of misbranding.

(2) Restricted Use Classification. 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 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 , the following statement is required: “For retail sale to and use only by Certified or under their direct supervision and only for those uses covered by the Certified 's .” If, however, other regulatory restrictions are imposed, the will define the appropriate wording for the terms of restriction by regulation.