40 CFR § 156.10 - Labeling requirements.
发布时间：2020-11-19 06:55:56 阅读量：572
40 CFR § 156.10 - Labeling requirements.
§ 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:
(iii) The net contents as prescribed in paragraph (d) of this section;
(v) The producing establishment number as prescribed in paragraph (f) of this section;
(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 theAct, “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.
(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 pesticideor 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;
(iv) A false or misleading comparison with other pesticides or devices;
(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.
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or
(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 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.
(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 thepesticide. 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 productat 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 orcontainer. 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 activeingredients 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 thepesticide, 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 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 theAdministrator 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 thepesticide 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 theingredient 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.
(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 pesticideproduct. Directions for use may appear on printed or graphic matter which accompanies thepesticide provided that:
(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:
(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.
(2) The Administrator determines that such directions are not necessary to prevent unreasonable adverse effects on man or the environment; and
(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 forpesticide 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) ofpesticide products involved;
(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 pesticideand its container, in accordance with subpart H of this part. 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 § 156.78(d)(1), 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 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 theAgency 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. Any pesticide product for which some uses are classified for general use and others for restricted use shall be separately labeled according to the labelingstandards 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 productsshall 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 usescontained in the Directions for Use will be considered a false or misleading statement under the statutory definitions of misbranding.
(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.