tent, such terms shall be used on the label.

(2) When there is no general usage in the trade with respect to the terms of weight or measure of a particular economic poison, the content must be stated in terms of liquid measure if the product is a liquid, and in terms of weight if it is a solid, semisolid, viscous, or a mixture of liquid and solid.

(i) Liquids include all substances which flow freely like water and thus can be readily measured. Oils of low viscosity such as kerosene, creosote oil and pine oil are liquids. Emulsions with low viscosity are liquids, but emulsions of high viscosity such as mayonnaise, or viscous tars are not liquids within the meaning of this definition.

(ii) The terms solid, semisolid, viscous and mixture of liquid and solid include all products other than liquids.

(3) Statements of liquid measure must be in terms of the United States gallon, quart, pint and fluid ounce at 68° F.; statements of weight must be in terms of avoirdupois pound and ounce.

(4) Some liquid economic poisons are usually sold by weight. Examples are nicotine sulfate solution containing 40 percent of nicotine and U. S. P. formaldehyde solution. The content of these liquid economic poisons must be stated in terms of weight.

(5) In a few cases economic poisons are sold in gelatine capsules and the contents of such capsules stated in terms of fluid drams. Where such usage has been general, the net content must be given in terms of the number of capsules each containing a stated number of fluid drams.

(6) Some disinfectants are made up in tablet form. When so prepared, objection will not be raised to giving the number of tablets and the weight of each.

(c) Units of weight or measure. Statements of net content must be in terms of the largest unit present, but in the case of added fractions of the largest unit, the fractional portion may be expressed in terms of a smaller unit. Thus, 31⁄2 pounds may be stated as "31⁄2 pounds" or "3 pounds, 8 ounces"; 51⁄2 gallons may be stated as "51⁄2 gallons" or "5 gallons, 2 quarts"; 34 quarts may be stated as "334 quarts," "3 quarts, 11⁄2 pints," or "3 quarts, 1 pint, 8 fl. oz." It is not permissible to state net contents such as 128 fluid ounces, 32 fluid ounces, 6 pints, 8 quarts, or 24 ounces since in each case

the statement is not in terms of the largest unit present.

(d) Permissible variations. (1) If the contents are stated as a minimum quantity, the package must contain at least the quantity claimed. No variation below this quantity is permitted and any variation above the contents stated must not be unreasonably large.

(2) The net content is considered to be the average net content unless stated as a minimum quantity. Where average net content is used:

(i) The average content of the packages in any shipment must not fall below the quantity stated and variation above the quantity stated is permitted only to the extent that it represents deviations unavoidable in good packing practice.

(ii) There must be no unreasonable variation from the average in the content of any package.

(e) Allowance for loss. A statement of net content "when packed" does not comply with the requirements of the act. The statement must be such that it will be correct as long as the economic poison is subject to the law. Thus, if a product such as borax may lose weight by drying out when stored in paper bags, it must be packed and labeled in such a way that the statement of net content will be correct when the product is purchased.

(f) Location and prominence of net content statement. (1) The net content statement must appear on the label of the container. It is not required to appear on the front panel of the label but it must be prominently placed with such conspicuousness as to render it likely to be read by the purchaser under customary conditions of purchase and use. In the case of drums or bags the net content may be plainly and conspicuously stenciled on the drum or bag. If a single label is printed for use on several different sizes of containers, the net content may be plainly inserted on each label with a rubber stamp or by any other methods which gives the information clearly.

(2) When the retail package contains smaller unit packets as, for example, for single doses, the net contents must appear on the retail package but need not appear on the individual packets. Thus, if a rodenticide is made up into individual baits enclosed in cellophane, and these baits are packed in a retail package, the net contents should be shown on the retail container but need not be

(a) Requirements of the Act. The Act and the regulations require that every economic poison which is subject to their provisions must be properly labeled including directions for use which may be necessary and, if complied with, adequate to protect the public.

(b) Contents of directions. The extent of detailed information required in the directions for use will vary, depending upon the nature of the proposed use, general knowledge of the economic poison and its uses, and possible hazards involved. In general, directions should include:

(1) The site of application of the economic poison including such factors as the crops, animals, areas, or objects to be treated;

(2) The rate of application to each site;

(3) Instructions on timing applications to obtain best results and to avoid adverse effects;

(4) Any necessary limitation or restriction such as the time required between application and harvest of food crops, warning against use on certain crops, animals, objects, or in certain areas; and

(5) Any other pertinent information which in the opinion of the Director is necessary for the protection of the public.

(c) When directions are required. Directions for use are required whenever they are necessary for the protection of the public. The public includes all persons who may be affected by the handling, storage, or use of the economic poison. Directions for use are necessary in the labeling of all products which are sold for use as economic poisons with the following exceptions:

(1) Detailed directions for use may be omitted from the labeling of well known economic poisons which are sold in containers of 100 pounds or more of a solid intended primarily for use undiluted, 50 pounds or more of a solid intended primarily for use after dilution, 55 gallons or more of a liquid intended primarily for use undiluted, or 20 gallons or more

of a liquid intended primarily for use after dilution; Provided:

(i) There is readily available general knowledge of the composition, methods of use, and effectiveness of the product for economic poison purposes;

(ii) Option 1 of the ingredient statement is followed; and

(iii) In the opinion of the Director, such directions are not necessary for the protection of the public.

(2) Detailed directions for use may be omitted from the labeling of economic poisons (as defined in Interpretation 3, Revision I) which are intended for use only by manufacturers of products other than economic poisons in their regular manufacturing processes; Provided:

(i) Option 1 of the ingredient statement is followed;

(ii) The label clearly shows that the product is intended for use only in manufacturing processes;

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

(iv) The economic poison will not come into the hands of the general public except after incorporation into such finished products; and

(v) In the opinion of the Director; such directions are not necessary for the protection of the public.

Detailed directions for use are not considered necessary in such cases since such uses are highly specialized and usually Exwell-known to the manufacturer. amples of such products would be those intended for use during the manufacturing processes in treating leather, wool, other fabrics, paints, building materials, and other materials for protection against any pest.

(3) Detailed directions for use may be omitted from the labeling of economic poisons for which sale is limited to physicians, veterinarians, or druggists; Provided:

(1) Option 1 of the ingredient statement is followed;

(ii) The label clearly states that the product is for use only by physicians or veterinarians, or for use as prescribed by physicians or veterinarians; and

(lii) In the opinion of the Director. such directions are not necessary for the protection of the public.

An example of such products would be benzyl benzoate to be used by, or its use

prescribed by physicians or veterinarians for use against the itch mite or mange mite.

(4) Detailed directions for use may be omitted from the labeling of economic poisons which are intended for use only by distributors or formulators in preparing economic poisons for sale to the public; Provided:

(i) Option 1 of the ingredient statement is followed;

(ii) There is readily available to the trade, information on the composition, toxicity, methods of use, applicable restrictions or limitations, and effectiveness of the product for economic poison purposes;

(iii) The label clearly states that the product is intended for use only in manufacturing, formulating, mixing, or repacking for use as economic poisons; and

(iv) In the opinion of the Director, such directions are not necessary for the protection of the public.

Examples of such products are 50 per-cent DDT and concentrated 2,4-dichlorophenoxyacetic acid intended for use by distributors or formulators in preparing economic poisons of a lower concentration for sale to the public.

(d) Where directions shall appear. The directions for use shall appear on the labeling of the economic poison. The labeling includes the label which is affixed to the product plus all printed or graphic matter which accompanies the product at any time. Directions for use may appear on the label or on accompanying leaflets or circulars.

(1) Directions for use may be placed on any part of the label; Provided:

(i) They are conspicuous enough to be easily read by the user of the economic poison.

(2) Directions for use may appear on printed or graphic matter which accompanies the economic poison; Provided:

(i) Such printed or graphic matter is securely attached to each package of the economic poison, or placed within the outside wrapper or bag, so that it will not under normal condition be lost during shipment, storage, or handling,

(ii) The label bears a reference to the directions for use on accompanying leaflets or circulars, such as "See directions on the enclosed circular," and

(iii) In the opinion of the Director it is not necessary for such directions to appear on the label.

(e) Adequacy and clarity of directions. (1) Directions for use must be stated in terms which can be easily read and understood by the average person likely to use the economic poison. Directions must be adequate when carefully followed, to protect the public from economic cheat and from personal injury or damage to property. This requires sufficient completeness to insure the proper use of the product so as to obtain the desired results in pest control without causing injury to man, beneficial animals, or beneficial plants. Directions need not be exhaustive in every case, since some of the common economic poisons are intended for use against a large number of pests. Frequently the methods of control in different parts of the country vary and they may vary in a single locality from year to year, depending on weather conditions. It would be manifestly impractical to include detailed directions for all uses on the labeling of many widely used economic poisons.

(2) The need for detailed directions for use will be greater on household or home garden products likely to be used by persons not well informed in the use of economic poisons than it will be in the case of products intended for large scale agricultural or commercial uses. The large scale user is more likely to be informed of the properties of economic poisons and also to rely on local agricultural authorities for advice. The need for detailed directions is also greater in the case of new economic poisons, or those of unusual composition than it is in the case of older, well-known materials.

(3) The following general considerations apply:

(i) Directions for use of economic poisons which are likely to be applied by householders or small gardeners, cattle raisers, etc., shall be sufficiently detailed to give full information on usage. They must include methods of application, time of application, rate of application, dilutions, any necessary limitations or restrictions and when necessary they shall provide for repeated treatments. The directions for use shall be consistent with the warning or caution statements on the label.

(ii) Directions for use of well-known, standardized economic poisons which will be applied by professional pest control operators, may be more general in na

ture, giving sites of application, pests to be controlled, and rates and methods of application.

(iii) Directions for use of new or unusual economic poisons shall be given in full detail, since information or advice on the use of the product from other sources is not likely to be available.

(f) Applicability of directions. Directions for use in the labeling of economic poisons will be considered to apply in all parts of the country in which the product is marketed unless the labeling makes a direct statement to the contrary. It has been found that some pests are more easily controlled in certain parts of the country than in others. If an economic poison has a nationwide distribution, the directions for use should apply to all parts of the nation. However, if work by the State experiment stations in certain sections of the country shows, for example, that concentrations lower than those recommended in the labeling of the product will be effective against a certain pest in those particular sections than is required in other sections, objection is not raised to recommendation of the weaker dilution in the particular sections involved or to a reference to agricultural authorities in those sections for information as to usage there. If the product is marketed only in the sections where the weaker dilution has been found effective, the weaker dilution may be recommended without reference to the dilution required elsewhere. However, a statement to that effect must accompany the application for registration.

(g) Broad claims. The directions for use must not bear any false or misleading claims. Examples of broad claims, which are not acceptable in most cases, include the following:

(1) Broad references to insects, plant diseases, weeds, rodents, or a list of pests followed by the abbreviation "etc." which are likely to be interpreted as implying that the product will kill or control any or all such pests. (Specific pests which the product will adequately control when used as directed, may be named and in some cases are required to be named.)

(2) Claims for extermination of insects, plant diseases, weeds, rodents, or other pests. (Claims for killing or controlling particular kinds of pests are acceptable and may be required if the product will give a reasonable control of such pests under the specified conditions of use.)

(3) Claims for sterilization in the case of germicides when the product will not kill resistant spores under the specified conditions of use.

(4) Claims implying effectiveness of the economic poison under all conditions of use if it is not effective under all such conditions. When a product is not effective under certain conditions, as for example, in the presence of dirt, at low temperatures, or in the presence of other chemicals, the directions should make it clear that such conditions are to be avoided.

The

(h) Responsibility for claims. shipper or guarantor of an economic poison is responsible for the accuracy of all claims made for it, including those in the directions for use. Therefore, only those claims which have been proven to be accurate, in that effective pest control is accomplished without injury to living man, beneficial plants or beneficial animals, should appear in the directions for use.

§ 162.106 Interpretation with respect to registration requirements.

(a) Products which must be registered. (1) Registration is required for all economic poisons that are distributed, sold or offered for sale in the District of Columbia or the territories, shipped or delivered for shipment in interstate commerce, exported, or imported from abroad, except economic poisons which are intended solely for experimental use. (These, however, may be subject to the permit requirements of the law.)

(2) Custom mixes (special mixtures of economic poisons prepared on the order of and according to the specifications of the purchaser), are subject to the act and must be registered. When rush shipment of such mixtures is required, special attention will be given to expediting the registration. When requested, telegraphic notification of registration at the expense of the registrant will be given.

(b) Products for which registration is not required. (1) Economic poisons which are made and used in the same state without entering interstate commerce need not be registered under the act since they are not subject thereto. However, registration will not be denied them since it is possible they may be shipped out of the state.

(2) Economic poisons which are delivered for shipment to any foreign country need not be registered when they are

prepared or packed in accordance with the specifications or directions of the foreign purchaser.

(3) Registration will not be issued for devices or other products which are not economic poisons.

(c) Who may register an economic poison. (1) Any manufacturer, packer, seller, distributor, or shipper of an economic poison may register it.

(2) If the manufacturer of an economic poison ships it in interstate or foreign commerce or distributes it in the District of Columbia or the Territories, he will normally register it himself since it must be registered before such shipment or distribution. This is true whether the manufacturer ships it under his own label or under a label bearing the distributor's name.

(3) If the manufacturer sells to a distributor in the same state, the manufacturer may or may not register the product, but if he has not, registration by the distributor will be required before the product is shipped in interstate commerce.

(4) If a distributor has an economic poison made for him by two or more manufacturers following exactly the same formula and labeled with identical labels which bear his name as distributor but make no reference to the actual manufacturer, the distributor may register the product, obtaining a single registration to cover the material from all sources of manufacture. On the other hand, each manufacturer may register the product which he furnishes to the distributor, but in this case the manufacturer can register his own product only and it will be necessary for each manufacturer to have a separate registration.

(1)

(d) The effect of registration. Registration is a device to bring the economic poison to the attention of the Environmental Protection Agency and to furnish an opportunity to correct obvious faults in labeling. It does not place the responsibility for correct labeling upon the Agency though the Agency does advise relative to revision of labeling, on the basis of available information. The shipper of the goods or the guarantor is responsible for the compliance of his labeling with legal requirements. Before placing the article on the market, he should have it thoroughly tested by experimentors competent to judge its effectiveness and make only such claims as are justified by the results of their

tests. If it is likely to cause injury to human beings, or desirable plants or animals, its limitations from these standpoints should be determined and adequate cautions placed on the label. Determination should be made as to whether it is highly toxic within the meaning of the act and regulations and, if so, the label must bear the statements required with respect to highly toxic products. It is the purpose of the act to protect the public before injury occurs rather than to subject the public to the dangers of experimentation and take action only after injury has occurred.

(2) Registration is not to be understood as indicating the Environmental Protection Agency's approval or recommendation of the economic poison.

(3) Federal registration does not remove the requirements for state registration in those states which require registration.

(4) When the economic poison has been registered, no further registration under the act is required if the product is in the manufacturer's or registrant's original unbroken immediate container, and if the claims made for it and the directions for its use do not differ in substance from the representations made in connection with the registration.

(e) Multiple products. A single registration applies only to a single economic poison, that is, to a product having the same composition, usually manufactured by the same person, and the labeling of which is identical with and bears the same claims as those covered by the registration. If a single registration is to cover the same product sold under other trade names and bearing the names and addresses of the distributors, statements showing such other names and labels shall be filed with the Pesticides Regulation Division. Thus, when a manufacturer prepares an economic poison under a stock label which does not bear his name but on which he prints names of the product and names and addresses of distributors, who obtain the product from him, the manufacturer may register the product under his name and file an additional statement showing the trade names under which the product will be sold and the names and addresses which will appear on the label. These additional statements may be filed at any time before the goods become subject to the law.

(f) Procedure for registration. (1) Applications for registration should be