continuing, in which case, in its application to any shipment or other delivery of a product it shall be considered to have been given at the date when such product was shipped or delivered by the person giving the guarantee.

(e) Expiration of guarantee. Any guarantee shall expire when the product is repacked or relabeled by the purchaser or when it becomes in violation of the Act or the regulations in this part after shipment or other delivery by the person giving the guarantee.

(f) Forms of guarantee. The following are suggested forms of guarantee: (1) Limited form for use on invoice or bill of sale.

ified in the regulations in this part dur. ing ordinary conditions of marketing or storage, and must not cause the product to be ineffective or result in its causing damage when used as directed.

(b) Arsenicals and barium fluosilicate. Standard lead arsenate, basic lead arsenate, calcium arsenate, magnesium arsenate, zinc arsenate, zinc arsenite, and barium fluosilicate shall be colored any hue, except the yellow-reds and yellows, having a value of not more than 8 and a chroma of not less than 4, or shall be discolored to a neutral lightness value not over 7.

(c) Sodium fluoride and sodium fluosilicate. Sodium fluoride and sodium fluosilicate shall be colored blue or green having a value of not more than 8 and a chroma of not less than 4, or shall be discolored to a neutral lightness value not over 7.

(d) Exceptions. (1) Notwithstanding the provisions of paragraphs (b) and (c) of this section, the Director, after opportunity for hearing, may permit other hues to be used for any particular purpose if he determines that use of the prescribed hues is not feasible for such purpose and that such action will not be injurious to the public.

(2) Any economic poison specified in this part which is intended solely for use by a textile manufacturer or commercial laundry, cleaner or dyer as a mothproofing agent, which would not be suitable for such use if colored and which will not come into the hands of the public except when incorporated into a fabric may be exempted by the Director from the requirements of section 3.a.(4) of the Act and the requirements of this section.

(3) The economic poison sodium fluoride shall be exempt from the requirements of section 3.a.(4) of the Act and paragraph (c) of this section when (1) ft is intended for use as a fungicide solely in the manufacture or processing of rubber, glue, or leather goods; (ii) coloration of the economic poison in accordance with said requirements will be likely to impart objectionable color characteristics to the finished goods; (iii) the economic poison will not be present in such finished goods in sufficient quantities to cause injury to any person; and (iv) the economic poison will not come into the hands of the public except after incorporation into such finished goods.

An economic poison is adulterated if its strength or purity falls below the professed standard or quality as expressed on its labeling or under which it is sold, or if any substance has been substituted wholly or in part for the article, or if any valuable constituent of the article has been wholly or in part abstracted.

(a) A valuable constituent will be considered as wholly abstracted whenever the designation or representation of the product imports its presence therein and such constituent has been wholly omitted therefrom in the preparation of the product or has been wholly removed from the completed product.

(b) A valuable constituent will be considered as partly abstracted whenever the designation or representation of the product imports its presence therein, and such constituent is not present in the usual or customary amount or in the amount indicated in the labeling.

§ 162.14 Misbranding.

An economic poison or device is misbranded if the article or its labeling is false or misleading to the public in any particular.

(a) Examples of statements or representations in the labeling of an economic poison or device which render it misbranded are the following:

(1) A false or misleading statement concerning composition of the product.

(2) A false or misleading statement concerning the effectiveness of the product as an economic poison or device.

(3) A false or misleading statement about the value of the product for purposes other than as an economic poison or device.

(4) A false or misleading comparison with other economic poisons or devices.

(5) Unwarranted claims as to the safety of the economic poison or its ingredients, including a statement such as "safe," "non-poisonous," "non-injurious," or "harmless" with or without such a qualifying phrase as "when used as directed": Provided, however, That the Director may permit a truthful statement such as "non-toxic to humans and pets" on those products which are determined by the Director to be non-toxic to humans and pets.

(6) Any statement directly or indirectly implying that the economic poison or device is recommended or endorsed by any agency of the Federal Government.

(7) The name of an economic poison which contains two or more principal active ingredients if it suggests the name of one or more but not all such principal active ingredients even though the names of the other ingredients are stated elsewhere in the labeling.

(8) Prominent reference in the labeling to one or more active ingredients without giving their percentages in immediate proximity thereto or without giving equal prominence to the other active ingredients or to the inert ingredients.

(9) A true statement used in such a way as to give a false or misleading impression to the purchaser.

(b) Justification of false and misleading statements not permitted. (1) The use of any false or misleading statement on any part of the labeling, given as the statement or opinion of any person or based upon such statement or opinion, shall not be justified by the fact that the statement or opinion is actually that of such person.

(2) The use of a false or misleading statement in the labeling cannot be justlfied by an explanatory statement.

(a) Collection of samples. Samples of economic poisons and devices shall be collected by official inspectors or by any employee of the Federal Government, or of a State or Territory, or political subdivision thereof who has been duly authorized by the Director to collect samples.

(b) Examination of samples. Methods of examination of samples shall be those adopted and published by the Association of Official Agricultural Chemists, where applicable, or such other methods as the Director may find necessary to determine whether the product complies with the law.

(1)

(c) Notice of apparent violation. If, from an examination or analysis, an economic poison or device appears to be in violation of the Act, a notice in writing shall be sent to the person against whom criminal proceedings are contemplated, giving him 20 days within which

97-025-73-54

to offer such written explanation as he may desire. The notice shall state the manner in which the sample fails to meet the requirements of the Act and the regulations thereunder.

(2) Any such person may, in addition to his reply to such notice, file within 20 days of its receipt a written request for an opportunity to present his views orally in connection therewith.

(3) No notice or hearing is required prior to the seizure of any economic poison or device.

§ 162.16 Notices of judgment.

Publication of notices of judgments of the courts in cases arising under the criminal or seizure provisions of the Act shall be made in the form of notices, circulars, or bulletins as the Director may prescribe.

TEMPORARY PERMITS

§ 162.17 Limited shipments for experimental purposes.

Temporary permits not to exceed a period of one year may be issued for shipment of limited amounts of a product which is to be tested further, usually on a larger scale, to determine its limitations. Permits will be issued only for bona fide experimental programs under the supervision of qualified persons. The Director may require the submission of such information and data concerning the product and the program which he deems necessary for the protection of the public. If, in the opinion of the Director, such information has not been submitted he may, for the protection of the public, refuse to issue the permit.

(a) Articles for which no permit is required. (1) A substance or mixture of substances being put through tests in which the purpose is only to determine its value for economic poison purposes or to determine its toxicity or other properties, and where the user does not expect to receive any benefit in pest control from its use, is not considered an economic poison within the meaning of section 2a of the Act. Therefore, no permit under the Act is required for its shipment.

(2) An economic poison shipped or delivered for experimental use by or under the supervision of any Federal or State agency authorized by law to conduct research in the field of economic poisons shall not be subject to the provisions of the Act and the regulations in this part.

(b) Articles for which permit is required. (1) An economic poison shipped or delivered for experimental use by qualified persons but not under the supervision of a Federal or State agency authorized by law to conduct research in the field of economic poisons, for which a permit has been issued by the Director pursuant to the provisions of this section, shall otherwise be exempt from the provisions of the Act and of the regulations in this part. Permits will be of two types, specific and general. A specific permit will be issued to cover a particular shipment on a specified date to a named person. A general permit will be issued to cover more than one shipment over a period of time to the same or different persons.

(2) If an economic poison is to be tested in such a manner that residues may result in or on food or feed, a permit for shipment will not be issued unless:

(i) Sufficient data are submitted to the Director to show that no residue will be present on food or feed involved in the experimental program or

(ii) A tolerance or exemption from the need of a tolerance or a temporary tolerance or exemption from the need of a temporary tolerance, has been established by the Environmental Protection Agency to cover any detectable residue which may be present on food or feed involved in the experimental program and sufficient data are submitted to the Director to show that such program will not result in any residue in excess of any such tolerance or

(iii) The food or feed derived from the experimental program will be destroyed or fed only to laboratory animals or otherwise disposed of in a manner which will protect the public and which is approved by the Director.

(3) A permit for shipment of any experimental economic poison for testing in any place likely to be frequented by people will be granted only if it is clearly shown in the application for such permit that the applicant's instructions for use reasonably assure the avoidance of injury to all persons concerned.

(4) All applications for permits covering shipments for experimental use shall be filed in duplicate with the Pesticides Regulation Division, Environmental Protection Agency, Washington, D.C. 20250, and must be signed by the shipper and must contain the following:

(1) A certification to the effect that food or feed derived from the experimen

tal program will not be used or offered for consumption or sale for consumption, except by laboratory or experimental animals if illegal residues are present in or on such food or feed.

(ii) Name and address of the shipper and place or places from which the shipment will be made.

(iii) Proposed date of shipment or proposed shipping period not to exceed one year.

(iv) A statement of the composition of material to be covered by the permit which should apply to a single material or group of closely allied formulations of the material.

(v) A statement of the approximate quantity of material to be shipped.

(vi) Available data or information, or reference to available data or information, on the toxicity of the economic poison.

(vii) A statement of the nature of the proposed experimental program, including designation of the type of pests or organisms to be experimented with, the crops or animals on which the economic poison is to be used, a statement of the dates during which the proposed experimental program will be conducted, and the states or geographical areas where it is proposed to conduct the program, and including the results of previous tests where necessary to justify the issuance of a permit for the quantity requested.

(viii) The percentage of the total quantity of material specified under subdivision (v) of this subparagraph which will be supplied without charge to the

user.

(ix) A statement that the economic poison is intended for experimental use only.

(x) Proposed labeling which must bear (a) the prominent statement "For Experimental Use Only" on the container label and any accompanying circular or other labeling, (b) a warning or caution statement if in the opinion of the Director it is necessary, which statement shall, if complied with, be adequate in his opinion, for the protection of those who may handle or be exposed to the experimental formulations, (c) the name and address of the applicant for the permit, (d) the name or designation of the formulation, (e) an ingredient statement as prescribed in § 162.7, and (ƒ) necessary directions for use including crops or sites to be treated, limitations on dosage to be used, and if the economic poison is to be tested on food or feed

crops the number of days required between last application and harvest.

(5) The Director may limit the quantity of economic poison covered by a permit to such less quantity than requested as he may determine if the available information on effectiveness, or toxicity or other hazards, is not sufficient to justify the scope of experimental use proposed in the application, or may make such other limitations in the permit as he may determine to be necessary for the protection of the public.

(6) Reports on experimental program: During the period in which a permit is effective, the holder shall submit to the Director periodic reports regarding the status of the experimental program. Reports shall be submitted at 3-month intervals and at the end of the experimental program. These reports shall include the following information:

(i) Amount of the economic poison shipped during reporting period.

(li) Name and address of consignee of each shipment.

(iii) A summary of data on effectiveness, phytotoxicity, or other pertinent information obtained during the reporting period.

(iv) Any additional data on residues or analytical methods obtained during the reporting period.

(v) Any additional data on toxicity obtained during the reporting period.

(vi) Such other information and data as the Director may require.

The Director may at any time request additional reports on the experimentai program if, in his opinion, such reports are necessary for the protection of the public.

(7) An economic poison shipped under a permit shall not be offered for general retail sale.

(c) General permit for economic poisons for experimental use which are also subject to the new drug requirements of the Federal Food, Drug, and Cosmetic Act. (1) Notwithstanding the provisions of paragraph (b) of this section, a general permit is hereby issued under section 7.a. (4) of the Act to the manufacturers and shippers of economic poisons for experimental use only, to ship such economic poisons: Provided, (1) That the product is a "new drug" within the meaning of section 201(p) and 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. sec. 321(p) and sec. 355); (ii) that it is subject to, and the manu

facturer or shipper complies with, the provisions of section 505 (1) of said Act (21 U.S.C. sec. 355(1)) and § 130.3 of the regulations (21 CFR 130.3) thereunder; and (iii) that the documents referred to in said § 130.3 shall be made available for inspection upon the request of any officer or employee of the Environmental Protection Agency at any reasonable time within two years after the introduction of the product into interstate commerce.

(2) The general permit referred to in the preceding subparagraph shall apply only insofar as the experimental uses are for drug purposes within the meaning of the Federal Food, Drug, and Cosmetic Act. It shall not apply to other experimental uses even though the product may be intended for both drug and nondrug uses.

(d) Cancellation of permits. Any permit for shipment for experimental use may be canceled at any time for any violation of the terms thereof or if it shall appear to the Director that the permit should be canceled for the protection of the public.

§ 162.18 DDT products.

All persons who distribute, sell, offer for sale, hold for sale, ship, deliver for shipment, or receive and (having so received) deliver or offer to deliver, any pesticide containing DDT [1,1,1-trichloro-2,2-bis (p-chlorophenyl) ethane], whether or not such pesticide is sold, offered for sale, held for sale, shipped, delivered for shipment, or received in intrastate commerce, are required to apply for registration pursuant to section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act as amended (86 Stat. 979), under the rules and regulations of this part as they relate to the registration of pesticides.

[38 FR 9089, Apr. 10, 1973]

§§ 162.19-162.24 [Reserved]

DECLARATION OF PESTS

§ 162.25 Forms of plant and animal life and viruses declared to be pests.

(a) Each of the following forms of plant and animal life and viruses is declared to be a pest under the Act when it exists under circumstances that make it injurious to plants, man, domestic animals, other useful vertebrates, useful invertebrates, or other articles or substances:

Mammals, including but not limited to dogs, cats, moles, bats, wild carnivores, armadillos, and deer;

Birds, including but not limited to starlings, English sparrows, crows, and black. birds;

Fishes, including but not limited to the jawless fishes such as the sea lamprey, the cartilaginous fishes such as the sharks, and the bony fishes such as the carp; Amphibians and reptiles, including but not limited to poisonous snakes;

Aquatic and terrestrial invertebrates, including but not limited to slugs, snails, and crayfish;

Boots and other plant parts growing where not wanted;

Viruses, other than those on or in living man or other animals.

All terms used in §§ 162.30 to 162.38, inclusive, shall have the meaning set forth for such terms in the Federal Insecticide, Fungicide, and Rodenticide Act and § 162.2 of the regulations promulgated by the Administrator of the Environmental Protection Agency thereunder. In addition the term "Collector of Customs" means any person authorized under the customs laws and regulations to perform the duties of a collector of customs.

CROSS REFERENCE: For regulations of the Bureau of Customs, Department of the Treasury, see 19 CFR Chapter 1.