40 CFR § 172.4 - Applications.

§ 172.4 Applications.

(a) Time for submission. An application or request for amendment to an existing permit shall be submitted as far as possible in advance of the intended date of shipment or use to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b).

(b) Contents of applications -

(1) General requirements.

(i) The name and address of the applicant;

(ii) The registration number of the product, if registered;

(iii) The purpose or objectives of the proposed testing; a description in detail of the proposed testing program including test parameters; a designation of the pest organism(s) involved; the amount of pesticide product proposed for use; the crops, fauna, flora, sites, modes, dosage rates, and situation of application on or in which the pesticide is to be used; the States in which the proposed program will be conducted; the number of acres, number of structural sites, or number of animals by State to be treated or included in the area of experimental use; the proposed dates or period(s) during which the testing program is to be conducted; and the manner in which supervision of the program will be accomplished;

(iv) The name, street address, telephone number, and qualifications of all participants in the program (whether or not in the employ of the applicant). A permit must be amended to add or change participants;

(v) The name and street address of all cooperators, if available at the time an application is submitted or as soon thereafter as available;

(vi) A description and the specific results of any appropriate prior testing of the product conducted by the applicant to determine toxicity and effects in or on target organisms at the site of application; and to determine phytotoxicity and other forms of toxicity or effects on nontarget plants, animals, and insects at or near the site of application; and to determine adverse effects on the environment;

(vii) The proposed method of storage and disposition of any unused experimental use pesticide and its containers; and

(viii) Such other additional pertinent information as the Administrator may require.

(2) Requirement for tolerance. If the experimental use pesticide is to be used in such a manner that any residue can reasonably be expected to result in or on food or feed, the applicant must:

(i) Submit evidence that a tolerance or exemption from the requirement of a tolerance has been established for residues of the pesticide in or on such food or feed under section 408 of the Federal Food, Drug, and Cosmetic Act; or

(ii) Submit a petition proposing establishment of a tolerance or an exemption from the requirement of a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act; or

(iii) Certify that the food or feed derived from the experimental program will be destroyed or fed only to experimental animals for testing purposes, or otherwise disposed of in a manner which will not endanger man or the environment. The method of such destruction or disposition shall be provided in the application for the permit.

(3) Additional requirements for unregistered pesticide products.

(i) A complete confidential statement of composition for the formulation to be tested giving the name and percentage by weight of each ingredient, active and inert;

(ii) Chemical and physical properties of each active ingredient of the formulation to be tested, including, but not limited to, the manufacturing or laboratory processes and analytical methods suitable for determining the active ingredients in the formulation;

(iii) Appropriate date, if available, on the rate of decline of residues on the treated crop or environmental site or other information for determination regarding entry of persons into treated areas; and

(iv) Results of toxicity tests and other data relevant to the product's potential for causing injury to the users or other persons who may be exposed, including any available epidemiological information as to man.

(c) Fees. The payment of fees for experimental use permits shall apply as specified in subpart U of part 152 of the chapter.

[40 FR 18782, Apr. 30, 1975, as amended at 53 FR 19115, May 26, 1988; 71 FR 35546, June 21, 2006; 73 FR 75599, Dec. 12, 2008]