(j) Official inspector. "Official inspector" means any employee or agent of the Environmental Protection Agency or the Treasury Department authorized by the Director or by the Secretary of the Treasury to make investigations in connection with enforcement of the Act.

(k) Vertebrate animals. "Vertebrate animals" means all species of the subphylum vertebrata including domestic vertebrates and vertebrate species of fish and wildlife.

(1) Invertebrate animals. "Invertebrate animals” means all forms of animal life other than vertebrate animals, including both domestic and wild species. § 162.3

Administration.

All statements, words, and other information required by the Act or the regulations in this part to appear on the label or labeling of any economic poison shall be in the English language: Provided, That shipments of articles intended solely for sale in foreign countries may bear labels or labeling in the appropriate foreign language. The Director may permit the use of an appropriate foreign language version of the label or labeling in addition to the English version on products intended for distribution in areas of the United States where a large percentage of the population does not speak English.

§ 162.6 Labeling.

(a) Contents of label and labeling. The label of every economic poison must show, clearly and prominently, the name, brand or trademark under which the product is sold; the name and address of the manufacturer, registrant, or person for whom manufactured; the net contents as prescribed in paragraph (e) of this section; an ingredient statement as prescribed in § 162.7; the registration number assigned to the economic poison as prescribed in paragraph (f) of this

section, and an appropriate warning or caution statement as prescribed in § 162.9. The label or labeling of every economic poison must bear directions for use which are necessary and if complied with, adequate for the protection of the public.

(b) Placement of label. The label shall appear on the economic poison or the immediate container thereof. If the immediate container is enclosed within a wrapper or outside container through which the label cannot be clearly read by a person with normal vision, the label must also appear on such outside wrapper or container if it is a part of the retail package.

(c) Name and address of manufacturer, distributor, packer, formulator, or registrant. An unqualified name and address given on the label shall be considered as the name and address of the manufacturer. If the registrant's name appears on the label and the registrant is not the manufacturer, or if the name of the person for whom the economic poison was manufactured 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 manufacturer. If a person has two or more locations at which an economic poison is manufactured or packaged, or from which it is distributed, the name and address of the person's principal office will be accepted except in cases where the Director determines that the address of the exact location is necessary for the protection of the public. The address of the manufacturer, registrant, or person for whom manufactured shall include the street address, if any, unless the street address is shown in a current city directory or telephone directory.

(d) Name, brand, or trade-mark of economic poison. The name, brand, or trade-mark of the economic poison, appearing on the label shall be that under which the economic poison is registered.

(e) Net content. (1) The net content shall be exclusive of wrappers or other material, and shall be deemed to be average content unless stated as a minimum quantity.

(2) Net content shall be stated in the terms of weight or measure in general use by consumers and users of the type of economic poison to give accurate information as to the quantity of the economic poison. If there is no general use,

the net content statement shall be in terms of liquid measure if the product is a liquid, and in terms of weight if it is solid, semi-solid, viscous, or a mixture of liquid and solid. Statements of liquid measure shall be in terms of the United States gallon, quart, pint, and fluid ounce at 68° F. The statements of weight shall be in terms of avoirdupois pound and ounce. All statements of net content shall be in terms of the largest unit present.

(3) If the contents are stated as a minimum quantity, variation below the stated quantity is not permissible and variation above shall not be unreasonably large.

(4) If the contents are not stated as a minimum quantity, variation shall be permitted only to the extent that it represents deviations unavoidable in good packing practice. The average quantity in the packages in a shipment shall not fall below the average quantity stated. nor shall there be any unreasonable variation from the average in the contents of any package.

(f) Registration number. The registration number assigned to an economic poison at the time of registration shall appear on the label of such economic poison. The number must be the same as that appearing on the notice of registration and shall be preceded by the phrase "EPA Registration No.," or the phrase "EPA Reg. No." all of which shall be 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 shall not appear in a manner which would make it misleading to the public.

(g) Legibility of label and labeling. All words, statements, graphic representations, or designs required by the regulations in this part to appear on the label or labeling must be clearly legible and easy to read by a person with normal vision. The signal word, when required, and the statement "Keep out of reach of children" prescribed in § 162.9(a) shall be of a size bearing a reasonable relationship to the other type on the front part of the label and to the size of the container. The signal word, when required, shall not be less than 18 point type and the said warning statement shall not be less than 12 point type, unless the label space on the container is too small to accommodate such type sizes in which case the Director shall prescribe the type size. When the size of the label space

requires a reduction in type size, the reduction shall be made to a size no smaller than is necessary and in no event to a size smaller than 6 point type.

§ 162.7 Ingredient statement.

(a) Location of ingredient statement. The ingredient statement must appear on the front panel or that part of the label displayed under customary conditions of purchase, except in cases where the Director determines that, due to the size or form of the container, a statement on that portion of the label is impracticable, and permits such statement to appear on another side or panel of the label. Regardless of the placement of the ingredient statement on the label, it shall be sufficiently prominent and in type size which can be easily read by a person with normal vision. The ingredient statement must run parallel with other printed matter on the panel of the label on which it appears and must be on a clear contrasting background not obscured or crowded.

(b) Names of ingredients. The wellknown common name of each of the listed ingredients must be given or, if an ingredient has no common name, the correct chemical name which conforms most closely with generally accepted rules of chemical nomenclature. If there is no common name and the chemical composition is complex, the Director may permit the use of a new or coined name which he finds to be appropriate for the information and protection of the user. If the use of a new or coined name is permitted, the Director may prescribe the terms under which it may be used. A trade-mark or trade name shall not be used as the name of an ingredient except when it has become a common name.

(c) Percentages of ingredients. Percentages of ingredients shall be determined by weight and the sum of the percentages of the ingredients shall be 100. Sliding scale forms of ingredient statements shall not be used.

(a) Economic poisons which fall within any of the following categories when tested on laboratory animals as specified in subparagraphs (1), (2), or (3) of this paragraph are highly toxic to man or contain substances or quantities of substances highly toxic to man within the meaning of the Act (such economic poisons being hereinafter in this part referred to as economic poisons highly toxic to man): Provided, however, That the Director may, upon application and after opportunity for hearing, exempt any economic poison which is in any of these categories, but which is not in fact highly toxic to man, from the requirements of the Act and the regulations in this part with respect to economic poisons highly toxic to man:

(1) Oral toxicity. An economic poison which has a single dose LD50 of 50 milligrams or less per kilogram of body weight when administered orally to both male and female rats which have been fasted for a period of 24 hours (or to other rodent or nonrodent species specified by the Director); or

(2) Toxicity on inhalation. An economic poison which has an LC50 of 2,000 micrograms or less of dust or mist per liter of air or 200 parts per million or less by volume of a gas or vapor, when administered by continuous inhalation for one hour to both male and female rats (or to other rodent or nonrodent species specified by the Director), if the Director finds that it is reasonably foreseeable that such concentration will be encountered by man; or

(3) Toxicity by skin absorption. An economic poison which has an LD50 of 200 milligrams or less per kilogram of body weight when administered by continuous contact for twenty-four hours with the bare skin of rabbits (or other rodent or nonrodent species specified by the Director).

(b) Tests on other species. Tests on other specified rodent or nonrodent species may be required by the Director

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with respect to individual economic poisons or to classes of economic poisons whenever he finds that tests on other species are necessary to determine whether an economic poison is highly toxic to man.

(c) Terms LD50 and LC50. An LD50 as used in connection with oral toxicity and skin absorption toxicity tests specified in paragraph (a) (1) and (3) of this section is the dose and LC50 as used in connection with inhalation tests specified in paragraph (a) (2) of this section is the concentration which is expected to cause death within 14 days in 50 percent of the test animals so treated.

ence.

(d) Toxicity based on human experiIf the Director finds, after opportunity for hearing, that available data on human experience with any economic poison indicate a toxicity greater than that determined from the above described tests on animals, the human data shall take precedence and, if he finds that the protection of the public so requires the Director shall declare such an economic poison to be highly toxic to man for the purposes of this Act and the regulations thereunder. § 162.9 Warning or caution statement.

Warning or caution statements, which are necessary and, if complied with, adequate to prevent injury to living man and useful vertebrate animals, useful vegetation, and useful invertebrate animals, must appear on the label in a place sufficiently prominent to warn the user, and must state clearly and in nontechnical language the particular hazard involved in the use of the economic poison, e.g., ingestion, skin absorption, inhalation, flammability or explosion, and the precautions to be taken to avoid accident, injury, or damage.

(a) The label of every economic poison shall bear warnings or cautions which are necessary for the protection of the public, including the statement, "Keep out of reach of children,” and a signal word such as "Danger," "Warning," or "Caution" as the Director may prescribe, on the front panel or that part of the label displayed under customary conditions of purchase: Provided, however, The Director may permit reasonable variations in the placement of that part of the required warnings and cautions other than the statement "Keep out of reach of children" and the required signal word, if in his opinion such variations would not be injurious to the

public. If an economic poison is marketed in channels of trade where the likelihood of contact with children is extremely remote, or if the nature of the product is such that it is likely to be used on infants or small children without causing injury under any reasonably foreseeable conditions, the Director may waive the requirement of the statement "Keep out of reach of children" if in his opinion such a statement is not necessary to prevent injury to the public. The Director may permit a statement such as "Keep away from infants and small children" in lieu of the statement "Keep out of reach of children" if he determines that such a variation would not be injurious to the public.

(b) The label of every economic poison which is highly toxic to man as described in § 162.8 shall bear the word "Danger" along with the word "Poison" in red on a contrasting background in immediate proximity to the skull and crossbones and an antidote statement including directions to call a physician immediately, on the front panel or that part of the label displayed under customary conditions of purchase: Provided, however, The Director may permit reasonable variations in the placement of the antidote statement if some reference such as "See antidote statement on back panel" appears on the front panel near the word "Poison" and the skull and crossbones.

(a) Eligibility. Any manufacturer, packer, seller, distributor, or shipper of an economic poison is eligible to apply for registration of such economic poison.

(b) Effect of registration. If an economic poison is registered under the Act no further registration under the Act by other persons is required: Provided, That

(1) The product is in the manufacturer's or registrant's original unbroken immediate container; and

(2) The claims made for it and the directions for its use do not differ from the representations made in connection with registration; and

(3) The product contains the labeling accepted in connection with registration and otherwise complies with the Act.

(c) Procedure for registration. Applications for registration should be addressed to Pesticides Regulation Division, Environmental Protection Agency, Washington, D.C., 20250. Application forms will be furnished upon request. All ap

plications for registration shall be accompanied by duplicate copies of the proposed labeling, including all printed or graphic matter which is to accompany the economic poison at any time and, if requested by the Director, a full description of the tests made and the results thereof upon which the claims for the economic poison are based, together with such other information as may be necessary to assure compliance with the Act and the regulations in this part. If any part of the proposed labeling submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. Applications should be submitted as far in advance as possible, and at least 30 days, before it is desired that registration take effect. However, the period of time required to process applications to determine the adequacy of the proposed labeling may exceed 30 days in some cases. Applications which require consultation with other governmental agencies will take a longer period of processing. No fees are charged for registration.

(d) Registration number. When an economic poison is registered under the Act, the Director shall assign a registration number to the economic poison. The registration number shall consist of a number assigned to the registrant, immediately followed by a hyphen and a number assigned to the product. For distributor products marketed under supplemental registration, the product number must be followed by a hyphen and the number assigned to the distributor. This may also include a letter designation of revised or amended registration as required by State law.

(e) Effective date of registration. Registration of an economic poison shall become effective on the date the notice of registration is issued.

(f) Responsibility of applicant for registration. The applicant for registration is responsible for the accuracy and completeness of all information submitted in connection with his application for registration of an economic poison.

(g) Changes in labeling or formulas. (1) Changes in the labeling or changes in the formula of a registered economic poison must be submitted in advance to the Pesticides Regulation Division, Environmental Protection Agency, Washington, D.C. 20250. The registrant must describe the exact changes desired and the proposed effective date and, upon re

quest, shall submit a description of tests which justify such changes.

(2) After the effective date of a change in labeling or formula, the product shall be marketed only under the new claims or formula: Provided, however, The Director may permit a reasonable time for the disposition of stocks of the discontinued product, if in his opinion such an extension would not endanger the public.

(h) Claims must conform to registration. Claims made for an economic poison must not differ from representations made in connection with registration, including representations with respect to effectiveness, ingredients, directions for use, or pests against which the product is recommended.

(i) Duration of registration. If at any time it does not appear to the Director that the economic poison is such as to warrant the proposed claims for it or if the economic poison and its labeling and other material required to be submitted do not comply with the provisions of the Act, the Director shall notify the registrant of the facts involved and afford him an opportunity to bring the product and its labeling into compliance with the Act. If after a reasonable period of time, the registrant has not made such corrections, the Director may cancel the registration under the provisions of section 4.c. of the Act. Unless cancelled in accordance with this paragraph or with the acquiescence of the registrant, or unless continued in effect in accordance with the provisions of paragraph (1) of this section, the registration of an economic poison shall be cancelled at the end of a period of five years following the date of registration of such economic poison, or at the end of five years following the date of any subsequent registered change in formula or labeling, or at the end of five years following the date of any continuance of registration pursuant to paragraph (j) of this section: Provided, however, That prior to any such cancellation the Pesticides Regulation Division shall send to the registrant a notice of intent to cancel, and, in the event such notice is not sent to the registrant 30 days prior to the expiration of the five-year period, the registration shall remain in effect until 30 days following the date such notice has been sent to the registrant at his latest address submitted to the Pesticides Regulation Division.

(j) Continuance of registration. If a registrant desires to continue the registration in effect, he shall notify the Pesticides Regulation Division in writing and

it shall be continued in effect under the same terms as the original registration: Provided, however, That if, on the basis of information available at the time, it appears that the product or its labeling fails to comply with the Act, the registrant shall be so notified and afforded the opportunity to make the necessary corrections. If the corrections are not made, registration will be cancelled as provided in section 4.c. of the Act.

(k) Limitations on registrations. The Director may refuse to register any economic poison or any specific use thereof if, in his opinion, directions and warnings cannot be written which will prevent injury to the general public when the product is used in accordance with warnings and directions or in accordance with commonly recognized practices. If, however, such an economic poison is proposed for certain acceptable uses, the Director may require the label to bear a warning against specific unacceptable uses such as in the home or home garden. [36 F.R. 22496, Nov. 25, 1971, as amended at 36 F.R. 24802, Dec. 23, 1971]

GUARANTEES

§ 162.11 Guarantee of economic poison.

(a) By whom given; effect of guarantee. Any manufacturer, distributor, wholesaler, or other person residing in the United States may furnish to any person to whom he sells an economic poison a guarantee that the economic poison was lawfully registered at the time of sale and delivery to such person, and that the economic poison complies with all the requirements of the Act and of the regulations in this part. The Act provides that penalties for violation of section 3.a. of the Act shall not apply to a person who establishes that he has received a guarantee as specified in the Act.

(b) Reference to guarantee. No reference to a guarantee or suggestion that such a guarantee has been given shall be made in the labeling of any economic poison.

(c) Contents of guarantee. In order to afford effective protection, each guarantee must:

(1) Be signed by and contain the name and address of the person giving it; and

(2) State that the economic poison was lawfully registered at the time of sale and delivery and that it complies with all other requirements of the Federal Insecticide, Fungicide, and Rodenticide Act.