Terms used in this part have the same meaning as in the Act. In addition, as used in this part, the following terms shall apply:

Act means the Federal Insecticide, Fungicide and Rodenticide Act, as amended.

Applicant means any person who applies for an experimental use permit pursuant to section 5 of the Act.

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.

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

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.

Permittee means any applicant to whom an experimental use permit has been granted.

Value for pesticide purposes means that characteristic of a substance or mixture of substances which produces an efficacious action on a pest.

(a) Pursuant to section 5 of the Federal 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 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.

(a) An experimental use permit (EUP) is generally required for testing of any unregistered pesticide or any registered pesticide being tested for an unregistered use. However, as described in paragraph (b) of this section, certain of such tests are presumed not to involve unreasonable adverse effects and, therefore, do not require an EUP.

(b) Except as provided in subpart C of this part or as specifically determined by the Environmental Protection Agency (EPA), it may be presumed that EUPs are not required when:

(1) The experimental use of the pesticide is limited to:

(i) Laboratory or greenhouse tests,

(ii) Limited replicated field trials as described in paragraph (c) of this section to confirm such tests, or

(iii) Other tests as described in paragraph (c) of this section whose purpose is only to assess the pesticide's potential efficacy, toxicity, or other properties.

(2) The producer, applicator, or any other person conducting the test does not expect to receive any benefit in pest control from the pesticide's use.

(c) For purposes of paragraphs (b)(1)(ii) and (b)(1)(iii) of this section, the following types of experimental tests are presumed not to need an EUP:

(1) A small-scale test involving use of a particular pesticide that is conducted on a cumulative total of no more than 10 acres of land per pest, except that:

(i) When testing for more than one target pest occurs at the same time and in the same locality, the 10 acre limitation shall encompass all of the target pests.

(ii) 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 the tested pesticides) shall be destroyed or consumed only by experimental animals unless an appropriate tolerance or exemption from a tolerance has been established under the Federal Food, Drug, and Cosmetic Act (FFDCA) for residues of the pesticide.

(2) A small-scale test involving the use of a particular pesticide that is conducted on a cumulative total of no more than 1 surface acre of water per pest, except that:

(i) When the testing for more than one target pest occurs at the same time and in the same locality, the 1 acre limitation shall encompass all of the target pests.

(ii) Waters which are involved in or affected by such tests are not used for irrigation purposes, drinking water supplies, or body contact recreational activities.

(iii) Testing shall not be conducted in any waters which contain or affect fish, shellfish, plants, or animals taken for recreational or commercial purposes and used for food or feed, unless an appropriate tolerance or exemption from a tolerance has been established under the FFDCA for residues of the pesticide.

(3) Animal treatment tests involving the use of a particular pesticide that are conducted only on experimental animals which will not be used for food or feed, unless an appropriate tolerance or an exemption from a tolerance has been established for animal products and byproducts under the FFDCA for residues of the pesticide.

(d) The examples in paragraphs (c)(1), (c)(2), and (c)(3) of this section are not all-inclusive and do not preclude testing in larger areas or larger numbers of units if the intended use meets the criteria of paragraph (a) of this section. However, tests which do not come within the examples in paragraphs (c)(1), (c)(2), and (c)(3) of this section, absent a specific determination by EPA to the contrary, require an EUP. Persons intending to conduct tests who are uncertain whether the testing may be conducted without a permit may submit a request for determination to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b). Such a request shall include the information listed in § 172.4(b)(1)(ii) and (b)(1)(iii) and in the case of an unregistered product, the information in § 172.4(b)(3)(i).

(e) Notwithstanding paragraphs (b) through (d) of this section, EPA may, on a case-by-case basis, require that certain testing of a particular pesticide or class of pesticides be carried out under an EUP, if it is determined that such EPA oversight is warranted. If EPA determines that an EUP is required, it will notify the developer of the pesticide of the need for an EUP and provide opportunity for comment or objections before imposing the requirement.

(f) No EUP 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 FFDCA (21 U.S.C. 301 et seq.) as:

(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)).

(g) Paragraph (f) 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.

(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.

(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 chemicals not included in any previously registered pesticides, the Administrator 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.

(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.

Technical materials may be imported without registration in sufficient quantities to formulate a pesticide for which an Experimental Use Permit has been requested if the application for such permit states that such importation will occur.

(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) [Reserved]

(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.

(c) In addition to the reporting requirements provided for elsewhere in this part, in the case of any meat-producing animals or birds that receive a direct treatment or application of any experimental use pesticide, the name and location of the packing plant where the animals will be processed shall be sent to the U.S. Department of Agriculture, Animal and Plant Health Inspection Service, Washington, DC 20250, at least 10 days before the animals are to be shipped for slaughter. This requirement may be waived, on request, by the USDA. These provisions do not exempt treated food-producing animals and their products from compliance with other applicable inspection requirements.

(d) Failure to submit required reports may constitute grounds for revocation of the permit.

(e) For the purpose of supervising the use of experimental use pesticides, the Agency may require the permittee or any participant to give reasonable advance notification of the intended dates, times, and sites on which such experimental use pesticide will be applied.

(f) The permittee or participants in the experimental use program will permit any authorized representative of the Agency, upon presentation of official identification, entry, at any reasonable time, to any premises involved in the testing program to inspect and to determine whether there has been compliance with the terms and conditions of the permit.

Applications for renewal of experimental use permits and temporary tolerances, to provide for additional testing, shall be submitted prior to expiration of the permit. Requirements for renewals are the same as for applications under § 172.4, except that information previously submitted may be incorporated by reference.

(a) Refusal. At any time that the Administrator determines that an experimental use permit is not justified, or that the issuance of such a permit would cause unreasonable adverse effects on the environment, or that for any other reason provided for under the law a permit shall not be issued, he shall notify the applicant in writing.

(b) Revocation. The Administrator may revoke an experimental use permit if he finds that its terms or conditions are being violated or that its terms or conditions are inadequate to avoid unreasonable adverse effects on the environment, or if new evidence is obtained which demonstrates that the tolerance will be inadequate to protect the public health, or for failure to meet any other provision of this part 172. The Administrator will notify the permittee in writing of such revocation. The permittee shall notify all participants of such revocation as soon as possible after he receives notice of revocation. The revocation of a permit shall not preclude the Administrator from initiating civil or criminal sanctions for the violations of the permit conditions or otherwise as authorized by law.

(c) Hearing. In the event that an applicant for an experimental use permit wishes to contest the refusal to issue an experimental use permit, or an experimental use permittee wishes to contest the revocation of any such permit, he shall, within twenty days after receipt of notice of such refusal or revocation, file with the Administrator a written request for an opportunity to confer with the Administrator or his designee. Within twenty days after such conference, the applicant or permittee will be notified of the Administrator's final decision.

(a) Notice of receipt of an experimental use permit application. The Administrator shall publish notice in the Federal Register of receipt of an application for an experimental use permit upon finding that issuance of the experimental use permit may be of regional or national significance. This notice shall include:

(1) The active ingredients,

(2) Use pattern(s),

(3) Quantity of pesticide,

(4) Total acreage,

(5) Location of area of application,

(6) A statement soliciting comments from any interested persons regarding the application.

(b) Public hearing. The Administrator may hold a public hearing, and publish notice in the Federal Register of the date and location of the hearing, when he determines that there is sufficient interest in the application to warrant a hearing, based upon the comments received in response to the Notice of Receipt of an Application, or that a hearing would otherwise be in the public interest.

(c) Issuance of experimental use permit. The Administrator shall give prompt notice in the Federal Register of the issuance of an experimental use permit. The notice shall include:

(1) The active ingredients,

(2) Use pattern(s),

(3) Quantity of pesticide,

(4) Total acreage,

(5) Location of area of application,

(6) A statement indicating where the experimental use permit is available for public inspection.