Subpart A

$ 172.1 Definitions.

For the purposes of this part, the following terms shall defined as listed below:

(a) The term "Act" means the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (86 Stat. 973), and other legislation supplementary thereto and amendatory thereof.

(b) The term “applicant” means any person who applies for an experimental use permit, pursuant to section 5 of the Act.

(c) The term "cooperator" means any person who grants permission to a permittee or a permittee's designated participant for the use of an experimental use pesticide at an application site owned or controlled by the cooperator.

(d) The term "experimental animals" means individual animals or groups of animals, regardless of species, intended for use and used solely for research purposes and does not include animals intended to be used for any food purposes.

(e) The term “participant” means any person acting as a representative of the permittee and responsible for making available for use, or supervising the use or evaluation of, an experimental use pesticide to be applied at a specific application site.

(f) The phrase "value for pesticide purposes” means that characteristic of a substance or mixture of substances which produces an efficacious action on a pest.

(g) The term “permittee” means any applicant to whom an experimental use permit has been granted. Terms defined in the Act and not explicitly defined herein are used herein with the meaning given in the Act.

registered with this Agency or (2) a registered pesticide for a use not previously approved in the registration of the pesticide may apply to the Administrator at any time for an experimental use permit.

(b) Pesticides under experimental use permits may not be sold or distributed other than through participants and, if sold or distributed through participants, may be used only at an application site of a cooperator and in accordance with the terms and conditions of the experimental use permit. $ 172.3 Scope of requirement.

(a) A substance or mixture of substances being put through laboratory or greenhouse tests, or limited replicated field trials to confirm such tests, or other tests, in which the purpose is only to determine its value for pesticide purposes or to determine its toxicity or other properties, and from which the producer, applicator or any other person conducting the test does not expect to receive any benefit in pest control from its use, is not considered a pesticide within the meaning of the Act and no experimental use permit will be required. This purpose will be presumed for the following types of tests.

(1) Land use. Tests conducted on a cumulative total of not more than 10 acres involving use of a particular substance

mixture of substances against a particular pest, provided that any food or feed crops involved in, or affected by, such tests (including but not limited to, crops subsequently grown on such land which may reasonably be expected to contain residues of such substance or mixture) shall be destroyed or consumed only by experimental animals unless a tolerance or exemption from tolerance has been established.

(2) Aquatic use. Tests conducted on a total of not more than one surfaceacre of water involving use of a particular substance or mixture of substances against a particular pest, provided that (i) waters which are involved in, or which are affected by, such tests will not be used for irrigation purposes, drinking water supplies or body contact recreational activities

or

§ 172.2 General.

(a) Pursuant to section 5 of the Fed. eral Insecticide, Fungicide, and Rodenticide Act, as amended (86 Stat. 983), and except as herein provided by § 172.3, any person wishing to accumulate information necessary to register under section 3 of the Act and the regulations thereunder (1) a pesticide not

(1) A "new drug” (21 U.S.C. sec. 321(p) and sec. 355),

(2) A "new animal drug” (21 U.S.C. sec. 321(w) and sec. 360(b) or

(3) An "animal feed" (21 U.S.C. sec. 321(x)) containing a "new animal drug" (21 U.S.C. sec. 360(b).) Paragraph (d) of this section shall not apply when a purpose of such test is to accumulate information necessary to register a pesticide under section 3 of the Act.

and (ii) that no such tests may be conducted in any waters which contain, or which affect, any fish, shellfish or other plants or animals taken for recreation or commercial purposes and used for food or feed unless a tolerance or exemption from tolerance has been established.

(3) Animal treatments. Tests conducted only on experimental animals. No animals may be tested if they may be used in food or feed unless a tolerance or exemption from tolerance has been established.

(b) The above examples are not meant to be all inclusive nor to preclude testing in larger areas or larger numbers of units if the intended use falls within the meaning of 172.3(a). Tests which do not come within the above examples will not be presumed to fall within the meaning of 8 172.3(a) and the presumption will be that the test requires an experimental use permit. The Registration Guidelines specify, by way of further example, testing which requires an experimental use permit. The Agency will give consideration to the amendment of these regulations to add more examples of tests presumed to be for the purposes outlined in § 172.3(a) upon receipt of information indicating a need for such an amendment. Persons intending to conduct tests who are uncertain as to whether the testing may be conducted without a permit may submit a request for determination to the Registration Division. Such a request shall include the information listed in § 172.4(b)(1) (ii) and (iii) and in the case of an unregistered product, the information in § 172.4(b)(3)(i).

(c) Use of a registered pesticide in a test being conducted to determine its pesticidal value for a use not set forth on the label and where the requirements of § 172.3(a) above are met shall not require an experimental use permit.

(d) No experimental use permit is required for a substance or mixture of substances being put through tests for the sole purpose of gathering data required for approval of such substance or mixture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) as:

a

8 172.4 Applications.

(a) Time for submission. An application or request for amendment to an existing permit shall be submitted in triplicate to the Registration Division, Office of Pesticide Programs, Environmental Protection Agency, Washington, D.C. 20460, as far as possible in advance of the intended date of shipment or use. Applications will be processed as expeditiously as possible.

(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 (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 ilny available epidemiological information as to man.

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 a regulation promulgated under Section 409 of that Act; or

(ii) Submit a petition proposing establishment of a tolerance or an exemption from the requirement of a tolerance under section 408, or a regulation under Section 409, 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;

$ 172.5 The permit.

(a) Issuance. The Experimental Use Permit shall be issued when the Administrator determines that the conditions of Section 5 of the Act, and the regulations thereunder, have been met subject to such terms and conditions as the Administrator determines are warranted.

(b) Duration. Permits will be effective for a specified period of time, normally one year, depending upon the crop or site to be tested and the requirements of the testing program submitted. The applicant should propose a suitable duration of the permit commensurate with the program submitted. Permits and associated temporary tolerances may be renewed, extended, or amended upon request if circumstances warrant.

(c) Limitations. The quantity of a pesticide allowed by a permit may be less than requested if it is determined that the available information on efficacy, toxicity or other hazards, the need for data, or the adequacy of program supervision does not justify the quantity of the pesticide requested. Other limitations may also be placed in the permit if necessary for the protection of the public health and the environment.

(d) Additions. With respect to an experimental use pesticide containing any chemical or combination of chemi. cals not included in any previously registered pesticides, the Administrawhich an Experimental Use Permit has been requested if the application for such permit states that such im. portation will occur.

tor may require that additional studies be conducted during the permit period to gather data to support the establishment of tolerances and/or registration. To the extent practicable, the applicant will be notified of any such requirements before or at the time an experimental use permit is issued.

(e) Maintenance of records. All producers of pesticides produced pursuant to an experimental use permit shall maintain records in accordance with Part 169.

8 172.6 Labeling.

(a) Contents. Except as provided by paragraph (b) of this section, all pesticides shipped or used under an experimental use permit shall be labeled with directions and conditions for use which shall include the following:

(1) The prominent statement, “For Experimental Use Only";

(2) The Experimental Use Permit number;

(3) The statement, “Not for sale to any person other than a participant or cooperator of the EPA-approved Experimental Use Program";

(4) The name, brand, or trademark;

(5) The name and address of the permittee, producer, or registrant;

(6) The net contents;
(7) An ingredient statement;
(8) Warning or caution statements;

(9) Any appropriate limitations on entry of persons into treated areas;

(10) The establishment registration number, except in those cases where application of the pesticide is made solely by the producer; and

(11) The directions for use, except that the Administrator may approve the use of the experimental program as labeling provided that such program is to be distributed with the product.

(b) Supplemental labeling. In the case of a registered pesticide, the Administrator may, at his discretion, permit a pesticide to be used under an experimental use permit with supplemental labeling as approved by him.

§ 172.8 Program surveillance and report

ing of data. (a) The permittee shall supervise the test program and evaluate the results of testing at each site of application. It will further be the responsibility of the permittee to report immediately to the Administrator, or to any person designated by him, any adverse effects from use of, or exposure to, the pesticide.

(b) The permittee shall submit the following reports to the Registration Division during the experimental program.

(1) Unless otherwise directed, reports shall be submitted every three months from the date of the permit and shall include the following:

(i) Name and street address of the shipper of any pesticide covered by the permit and place or places from which shipped;

(ii) Name and street address of consignee;

(iii) Amount of each shipment;

(iv) Total quantities of the pesticide shipped and used during the reporting period;

(v) Total quantities of technical material imported to formulate pesticides covered by the permit;

(vi) List of States into which shipments were made; and

(vii) Summaries of the progress made and data obtained during the report period.

(2) A final report shall be submitted within 180 days after the expiration of the permit, unless a request for extension of time is approved, and shall include:

(i) All data gathered during the testing program; field notes need not be submitted but must be maintained and submitted upon request;

(ii) A description of the disposition of any pesticide containers and any unused pesticides including amounts disposed of and the method and site of disposition; and

(iii) The method of disposition of affected food and/or feed.

$ 172.7 Importation of technical material.

Technical materials may be imported without registration in sufficient quantities to formulate a pesticide for