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sent to the Pesticides Regulation Division, Environmental Protection Agency, Washington, D.C. 20250. No fee is required. Application forms may be obtained from the Plant Pest Control Division by request. Applications should be submitted as far in advance as possible and at least 30 days before it is desired that the registration take effect. In special cases, the Agency will try to issue registrations in less than 30 days, but dependence should not be placed on obtaining registration in a shorter period except for real emergencies.

(2) As many products may be submitted for registration as desired with one application form. If there is not room on the form to name all of the products, their names may be continued on a separate plain sheet of paper attached to it.

(3) The blank spaces on the form should be filled in and the form signed by the proposed registrant or, if the registrant is a firm, by a responsible officer.

(4) With the filled-in application for registration there should be submitted two "data sheets" for each product which it is desired to register. The "data sheet" should be 81⁄2 inches by 11 inches in size. A sheet of heavy typewriter paper is satisfactory. On each data sheet should be clearly stated the name of the product, the name and address of the registrant and, if it does not appear on the label, a statement giving the name and percentage of each active ingredient in the product and any pertinent information about the inert ingredients. To each data sheet there should be attached a specimen of the label for the product and specimens of any leaflets, circulars, or other advertising material accompanying the product. If the same label, except for statement of net contents, is used for several sizes of the product, information as to the different sizes should be given and the label for only the smallest size need be submitted. labels bearing different claims should be submitted. Before attaching the labels and other material to the "data sheet," the applicant should make sure that they include the required information which is as follows:

On the label:

All

(i) The name and address of the manufacturer, registrant, or person for whom manufactured,

(ii) The name under which the product is sold,

(iii) The ingredient statement, (iv) The net weight or measure of content,

(v) Any caution or warning statement which may be necessary and, if complied with, will be adequate to prevent injury to living man and other vertebrate animals, and useful vegetation and invertebrate animals,

(vi) In the case of highly toxic materials, the word "Poison" in red, the skull and crossbones and the antidote statement.

On the label, or on circulars, etc. accompanying the economic poison: Adequate directions for use when necessary for the proper use of the product.

(5) If the proposed registrant has doubt as to the legality of his labeling or proposed corrections for it, he may first submit a rough draft form for comment. After he has received the comment, he may revise and print the labeling and submit it in duplicate for registration.

(6) If the product is being recommended for any uses, or if any claims are being made for it, other than those on the labeling submitted, these should be shown on the data sheet. It is not desired, however, that the complete script of radio broadcasts, periodical advertising and other advertising material which does not accompany the econonic poison be submitted.

(7) When the application is received in the Pesticides Regulation Division, it is examined to determine whether the composition of the product appears to be such as to warrant the proposed claims for it and whether the product, its labeling, and other material submitted appear to comply with the requirements of the act.

(8) If the information submitted is not sufficient to furnish a basis for action, the applicant may be asked to furnish additional information such as the complete formula for the product and a full description of the tests upon which the claims for the product are based. If the article or its labeling does not appear to comply with legal requirements, the applicant is notified wherein it fails to comply and given an opportunity to make corrections.

(g) Effective period of registration. (1) The registration becomes effective on the date that the notice of registration is issued.

(2) A registration extends for five years unless canceled for cause or at the request of the registrant.

(3) The Agency can, at any time, cancel a registration and issue a registration under protest, if such action is found necessary to protect the public.

(4) The Agency can cancel the registration of an economic poison at the end of five years following the registration or at the end of any five-year period thereafter, unless the registrant, prior to the expiration of the five-year period, requests that such registration be continued in effect.

(5) A registration will be cancelled at any time on request of the registrant.

(h) Changes in labeling or formulas. (1) If changes in substance in the labeling of a registered product or changes in its formula are to be made, a statement of the contemplated changes must be submitted to the Agency in advance so that an amended registration or new registration may be issued, if such registration is justified.

(2) The statement should show or describe the exact changes to be made, describe any tests which justify the changes, and state the proposed effective date of the changes.

(3) The material submitted will be considered in the same manner as is an original submission. If new or amended registration appears justified, notification to that effect will be sent the registrant. Among reasons for which the new or amended registrations under the same name may be refused would be a reduction in strength or effectiveness of the product which would make it misleading to sell the new material under the old name.

(4) After the effective date of the new or amended registration the product shall be marketed only under the new claims or the new formula except that, upon request, a reasonable period of time may be allowed for the disposal of properly labeled old stocks. If the registrant desires to avail himself of this privilege, he should notify the Pesticides Regulation Division at the time of change of registration how much stock he has and when he expects it will be used up. Consideration will then be given to permitting its disposal.

(i) Registration under protest. (1) If upon receipt of a notice that his economic poison does not appear to warrant the claims made for it or that the article

or its labeling does not appear to comply with the provisions of the act, the proposed registrant insists that corrections are unnecessary and requests in writing that it be registered as submitted, the economic poison shall be registered under protest. The notice of registration under protest will be accompanied by a warning in writing of the apparent failure to comply with the law.

(2) In the case of conviction for an offense concerning which he has been warned in connection with the issuance of a registration under protest, the act provides that the registrant shall be fined not more than $1000 or imprisoned for not more than one year, or both fined and imprisoned, and the registration of the article shall terminate.

(3) Registration under protest should only occur when there is serious disagreement between the registrant and Agency officials concerning the efficacy of, or labeling required for, an economic poison. Disagreements may in some cases be due to misunderstandings as to requirements. When they arise, it is the purpose of the Agency to cooperate with the proposed registrant in an attempt to clear them up. It appears desirable that registration under protest be requested and issued only as a last resort.

§ 162.107 Interpretation with respect to advertising.

(a) Requirements of the Act. Section 3(a) of the Act prohibits interstate shipment or distribution of an economic poison if any of the claims made for it or any of the directions for its use differ in substance from the representations made in connection with its registration. This includes any representations made by the manufacturer or registrant anywhere and by any means, including periodical and radio or television advertising.

(b) Advertising which may also be used as labeling. Printed or graphic matter directly associated with the marketing of an economic poison, such as counter displays, window displays, or handouts distributed with the product, is labeling and must be submitted in connection with registration.

(c) Advertising not considered to be labeling. Section 4a (3) of the Act provides that an applicant for registration shall file a statement of all claims for the economic poison, including the directions for use. All claims and direc

tions for the use of an economic poison, regardless of where made, must be filed as a part of the application for registration. It is not required nor is it desired that copies of all advertising be filed if such advertising will never be used as labeling. However, under all circumstances, the claims to be made in such advertising should not exceed or differ in substance from those claims and directions which appear in labeling accepted in connection with registration under the Act.

(d) Cooperation with Federal Trade Commission. Advertising in periodicals and by television or radio is also subject to the laws enforced by the Federal Trade Commission. It is the policy of the Pesticides Regulation Division to cooperate with the Federal Trade Commission in order to avoid possible conflict with or duplication of efforts in the administration of the Federal Insecticide, Fungicide, and Rodenticide Act and acts administered by that agency. In accordance with this policy there has been established a liaison, which is now in operation, for continued cooperation and coordination between the Federal Trade Commission and the Pesticides Regulation Division in the enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Trade Commission Act as they apply to economic poisons. In general, the policy is for advertising, other than labeling, to be handled by the Federal Trade Commission. In the application of the above policy it is to be understood, however, that both agencies reserve the right to fully use their respective regulatory powers when necessary to protect the public interest.

§ 162.108 Interpretation with respect to labels for large containers.

(a) Requirements of the Act. The act and the regulations require labels on all containers of economic poisons which come within the scope of the act. There is no exemption in the case of large containers such as tank cars, tank trucks, or drums. Therefore, all such containers must be labeled.

(b) Where label must appear. (1) Labels for economic poisons in tank cars, may be attached to the panel borne by such cars for the purpose of attaching notices, or they may be placed directly on any conspicuous part of the tank where they can be easily read.

(2) Labels for economic poisons in tank trucks may be placed at any conspicuous place on the tank; however, when a tank truck is used only to deliver economic poisons to the user and the tank does not remain in the user's custody, a label attached to the tank would not be informative to the user. In such cases, the label may be attached to the delivery sheet which is carried by the driver of the truck and left with the user at the time of delivery.

(3) Labels for economic poisons in drums may consist of printed labels securely attached to the drums or labels may be stenciled on the drums. In either case labels must be clearly legible and easy to read.

(c) Contents of label. The following information must appear on the label:

(1) The name of the product. This must be the name under which it is registered with the Environmental Protection Agency.

(2) The name and address of the manufacturer, registrant, or person for whom manufactured.

(1) If the name is other than that of the manufacturer, the label should indicate this fact.

(ii) If the name is not that of the primary registrant, it must be the name of some other person or firm which has been added by a supplemental registration statement under the provisions of section 4a of the act.

(3) The net contents of the container, or in the case of a label attached to a delivery receipt of tank truck delivery, the net amount delivered.

(4) The ingredient statement.

(5) The registration number assigned to the economic poison as required in § 162.6(f).

(6) Any warning or caution statement which may be necessary to prevent injury to living man, beneficial animals, and beneficial plants. This statement is particularly important on large containers, since leakage may occur and result in injury to persons or property unless users or handlers are warned to take adequate precautions.

(7) In the case of an economic poison highly toxic to man, the skull and crossbones, the word "POISON" prominently in red, and an antidote statement.

(d) Directions for use. Directions for use are required on the labeling of economic poisons whenever they are necessary to protect the public.

(1) Detailed directions for use as prescribed in Interpretation 7 (Rev. 1) will be required on the labeling of all economic poisons for which the composition, methods of use, possible hazards involved, and effectiveness for economic poison purposes are not well known. Such directions for use may appear on the label or on other printed matter which is delivered to the user with the economic poison or otherwise accompanies the economic poison.

(2) 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:

(1) 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.

(e) Acceptable types of labeling. The following are examples of acceptable labels for two well known economic poisons.

(1) For creosote oil, free of water or free carbon.

CREOSOTE OIL

Active Ingredient 100% John Doe and Company Washington, D.C. Net contents 55 gallons

EPA Reg. No. xxx-xx

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§ 162.109 Interpretation with respect to

the guaranty of an economic poison. (a) Purpose of the guaranty. (1) The manufacturer of an economic poison is presumed to know the composition of his product and he will ordinarily be the one who registers it with the Environmental Protection Agency. He will, therefore, be in position to determine whether or not its shipment or distribution is legal.

(2) The distributor who purchases it from him will not be in a position to determine its composition except as he has it analyzed in a chemical laboratory and he will not know, except as his supplier may inform him, whether the product is registered. and what representations were made in connection with the registration. It will, therefore, be difficult for him to determine whether or not its shipment or distribution is legal.

(3) In order that the distributor may protect himself the act specifies that the penalties provided for violations of section 3a shall not apply to any person who establishes a guaranty, signed by and containing the name and address of the registrant or person residing in the United States from whom he purchased and received in good faith the article in the same unbroken package, to the effect that the article was lawfully registered at the time of sale and delivery and that it complies with the other requirements of the act, giving the name of the act in full. When the distributor holds such a guaranty, the guarantor is responsible for any violation involved in the shipment of the goods. However, the distributor, to avoid responsibility, must be able definitely to show that the economic poison in question is covered by a specific guaranty.

(b) Who may give guaranty. A guaranty may be given by any manufacturer, distributor, wholesaler, or any other person residing in the United States, who sells an economic poison to anyone else. (c) Scope and form of guaranty. A guaranty may be either limited to a specific shipment or it may be general and continuing in nature. The following forms of guaranty are suggested: (1) Limited form for use on invoice or bill of sale.

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(3) In some cases an invoice may cover shipment of both economic poisons covered by permit for experimental use and registered economic poisons. The guaranty cannot apply to the economic poisons shipped under permit. Therefore, the above forms of guaranty must be modified to be applicable to such procedure. It is suggested that in such cases the name of the experimental economic poison as shown on the invoice or bill of sale be immediately followed by the word "Experimental." Then the first form of guaranty should be changed to read:

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(e) Limitation of guaranty. The guaranty applies only so long as the economic poison remains unchanged in the manufacturer's or registrant's unbroken immediate container bearing his label. It expires when the immediate package is opened, when the material is repacked or relabeled, or when it has been otherwise changed so as to be in violation of the law after shipment or delivery by the person giving the guaranty. For example, a product may deteriorate when stored for any considerable length of time. It may have been in strict compliance with the law when shipped by the guarantor but a year later, when shipped by the distributor, it may have deteriorated and become worthless. In this case, the guaranty would not apply to the shipment a year later.

§ 162.110 Interpretation with respect to the analyzing and testing of economic poisons.

(a) Analyzing and testing of economic poisons; functions of the Department. Insofar as the Federal Insecticide, Fungicide and Rodenticide Act is concerned, the functions of the Environmental Protection Agency are those of a law enforcement agency. The Agency analyzes and tests economic poisons subject to the act to determine whether or not they are in violation of the provisions thereof. Its analytical and testing work is limited to official samples collected by official investigators or others who have been duly designated by the Director of the Pesticides Regulation Division. It cannot undertake such work to help a manufacturer prepare his labeling. It is the manufacturer's responsibility to have such work carried out, which may be done by commercial laboratories or by other qualified persons. The Agency is, however, willing to comment on proposed labeling submitted by manufacturers, based on available

information.

The Agency has no authority to recommend or to approve any specific commercial laboratory or person engaged in doing analytical or testing work on economic poisons.

§ 162.111 Interpretation with respect to shipments for experimental use; permit requirements.

(a) Shipments for experimental use by certain Federal and State agencies. The penalties provided for violation of section 3a of the act do not apply to

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