CHAPTER 9 - HOW TO APPLY FOR AN EXPERIMENTAL USE PERMIT A. GENERAL INFORMATION Experimental Use Permits (EUPs) are issued under FIFRA section 5 to allow prospective registrants to generate information or data necessary to register a pesticide under section 3 of FIFRA. You should refer to 40 CFR Part 172 for detailed information on EUPs. In general EUPs are issued for: 1. A pesticide not registered with the Agency, or 2. A registered pesticide for a use not registered with the Agency. Pesticides under experimental use permits may not be sold or distributed other than through participants in the approved experimental use program. They may only be used at the application site of a cooperator in the program, and only in accordance with the terms and conditions of the experimental use permit. B. WHEN IS AN EXPERIMENTAL USE PERMIT REQUIRED? 1. Generally, an EUP is required before you can conduct large scale field testing. Large scale field testing would be any instance other than those described in item 2 below. However, in certain cases (e.g., "novel" microbial pesticides -- certain genetically altered and non-indigenous microbial pest control agents as discussed in item 3 below) small scale field tests may require an EUP. IMPORTANT NOTE: EUPs are required for testing of pesticides in a comparable indoor situation, for example a pesticide to control roaches in domestic dwellings, institutions, etc. and for field testing of swimming pool sanitizers and disinfectants under actual use conditions. 2. EUPs are generally presumed not to be required for a substance or mixture of substances being put through laboratory or greenhouse tests, or limited replicated field trials, in which the purpose is only to determine its value for pesticidal purposes or to determine its toxicity or other properties, under the following circumstances: a. Land use - For tests conducted on a cumulative total of not more than 10 acres involving use of the test material against a particular pest, provided that any food or feed crops involved in or affected by the tests are destroyed or consumed only by experimental animals, unless a tolerance or exemption from a tolerance has been established. b. Aquatic use - For tests conducted on a total of not more than one surface-acre of water involving use of a test material against a particular pest, provided that such waters involved in or affected by the tests will not be used for irrigation, drinking water supplies, or body contact recreational activities. In addition, no tests may be conducted in waters that contain, or which affect any fish, shellfish or other plants or animals which may be taken and used for food or feed unless a tolerance or exemption from a tolerance has been established. c. Animal treatments - For tests conducted only on experimental animals. No animal may be tested if it may be used for food or feed purposes, unless a tolerance or exemption from a tolerance has been established. 3. Small scale field testing for "novel" microbial pesticides requiring an EUP - Due to concerns about the capability of microorganisms to reproduce and multiply in the environment and the potential for these microbials to cause unforseen adverse impacts, the Agency may require an EUP for small scale field testing of certain "novel" microbial pesticides (i.e., genetically-altered and non- indigenous microbial pest control agents). Refer also to the section on Application Requirements for an Experimental Use Permit, C.1.b. below. C. APPLICATION REQUIREMENTS FOR AN EXPERIMENTAL USE PERMIT Your application for an experimental use permit must contain or address the following: 1. General Requirements a. Conventional, Biochemical, and Most Microbial Pesticides 1) Application for Experimental Use Permit, EPA Form 8570-17. 2) EPA Registration Number of the product to be used, if registered. 3) Purpose or objectives of proposed testing. 4) A description in detail of the proposed testing program including: a) Test parameters b) A designation of the pest organism(s) involved c) The amount of pesticide product proposed for use d) The crops, fauna, flora, sites, modes, dosage rates and situations of application on or in which the pesticide is to be used e) The states, and counties within the state, in which the proposed program will be conducted f) The number of acres, number of structural sites, or number of animals by state and county to be treated or included in the area of experimental use g) The proposed dates or period(s) during which the testing program is to be conducted h) The manner in which supervision of the program will be accomplished IMPORTANT NOTE: It is very helpful in the Agency's review process if you include a table which indicates the states to which the product is to be shipped, and the pounds of product to be shipped to each state for each pest or pest complex, along with the total pounds of product to be shipped to each state. For example: EXPERIMENT USE PERMIT SUMMARY WORKSHEET COMPOUND: Cryptop TOTAL ACRES: 700 POUNDS A.I. REQUESTED: 2300 NUMBER OF APPLICATIONS (By Site): 1-Soybeans 2-Corn 5-Cotton | SITE (1) | SITE (2) | SITE (3) | SITE (4) | | TOTAL | Cotton | Corn | Soybeans | | TOTAL | LB. AI STATE| ACRES | ACRES | ACRES | ACRES | ACRES |SHIPPED AL | 200 | | 50 | | 250 | 1050 AR | 100 | | 50 | | 150 | 550 GA | 100 | 100 | 100 | | 300 | 700 | | | | | | TOTALS: 400 | 100 | 200 | | 700 | 2300 A tabular summary of this kind speeds review and processing of the experimental use permit. (See Appendix 9-1 for blank format). 5) The name, street address, telephone number, and qualifications of all participants in the program (whether or not in the employ of the applicant). A participant is 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 pesticide to be applied at a specific application site. 6) The name and street address of all cooperators, if available at the time the application is submitted or as soon as possible thereafter. Cooperators are persons who grant permission for an experimental use pesticide to be used on application sites which they own or control. 7) Information on prior testing - a description and the specific results of any appropriate prior testing of the product conducted by the applicant to determine, (a) toxicity and effects in or on any target organisms at the site of application, and (b) phytotoxicity and other forms of toxicity or effects on nontarget plants, animals and insects, at or near the site of application, or (c) any adverse effects on the environment. 8) The proposed method of storage and disposition of any unused experimental pesticide and its containers. 9) Any other additional pertinent information as the Agency may require. b. Small scale field testing - "novel" microbial pesticides (i.e., genetically altered and non- indigenous microbial pest control agents) Prior to the initiation of any small scale field testing which involves genetically altered or non- indigenous microbial pest control agents, the research organization, company, or individual must submit a notification to the Agency so that a determination can be made as to whether an EUP is required. You should also refer to Chapter 3 - Biochemical and Microbial Pesticides, Section D., Small-scale field testing Level I reporting and Level II notification requirements, for a more detailed discussion of the Agency's policy and requirements for small-scale field testing for microbial pesticides. 2. Tolerance requirements If the proposed 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 either 1) submit evidence that a tolerance or an 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 (FFDCA), or a regulation promulgated under section 409 of that Act, or 2) submit a request proposing establishment of a tolerance or a temporary tolerance under FFDCA section 408, or a regulation under section 409. Refer to Chapter 7, for a further discussion of tolerances. In lieu of submitting a request for a tolerance or temporary tolerance, the applicant may certify that the food or feed item resulting from the experimental use program will be destroyed or fed only to experimental animals to be used only for testing purposes (not for food or feed). 3. Data requirements If the proposed EUP is for an unregistered pesticide, the following information and/or data are required: a. Completed Confidential Statement of Formula, EPA Form 8570-4. b. Appropriate data in accordance with the data requirements identified in 40 CFR Part 158 for an experimental use permit. c. Reentry data, if available. d. Submitted data (3 copies) must be bound and formatted in accordance with the requirements of PR Notice 86-5. IMPORTANT NOTE: Each study must be separately bound. Confidential attachments and supplemental statements of data confidentiality must be included within the binding of the body of the study. All bindings must be secure, but easily removable to permit microfilming. (See PR Notice 86-5 and PR Notice 89-3 for specific instructions on binding of studies.) 4. Labeling requirements All pesticides shipped or used under an experimental use permit must be labeled with directions and conditions for use including the following: a. The prominent statement "For Experimental Use Only" b. The Experimental Use Permit Number c. The statement "Not for sale to any person other than a participant or cooperator of the EPA-approved Experimental Use Program" d. The name, brand or trademark e. The name and address of the permittee, producer, or registrant f. The net contents g. An ingredient statement h. Warning or caution statements i. Any appropriate limitations on entry of persons into treated areas j. The establishment registration number, except in those cases where application of the pesticide is made solely by the producer k. The directions for trial use IMPORTANT NOTE: Refer to Chapter 2, page 2-16 for label/labeling format information. 5. Extensions or renewal of Experimental Use Permits Experimental Use Permits and associated temporary tolerances are usually issued for a period of one or two years. The permit and any associated temporary tolerances, may be extended, renewed, or amended upon written request to the Agency, if circumstances warrant. 6. Fee Requirements If your application for an Experimental Use Permit is accompanied by a petition for a tolerance, temporary tolerance, an exemption from the requirement of a tolerance or a temporary tolerance exemption, the petition is subject to fee requirements as discussed in Chapters 7 and 8 of this manual. An extension or renewal request for a temporary tolerance is also subject to a fee requirement. IMPORTANT NOTE: 40 CFR 152.55 requires that inert ingredients, metabolites, and degradation products, as well as active ingredients, be cleared by the Agency if your product is to be used on food or feed crops. If your proposed labeling bears instructions for use of the product on food or feed crops, or if the intended use of the product results or may be expected to result, directly or indirectly, in pesticide residues in or on food or feed, you must submit a statement indicating whether a tolerance, exemption from the requirement of a tolerance, or a food additive regulation has been issued by the Agency under section 408 or 409 of the Federal Food Drug and Cosmetic Act (FFDCA). If a tolerance, exemption from the requirement of a tolerance, or a food additive regulation has not been issued for such residues, your application must be accompanied by a petition for establishment of appropriate tolerances, exemptions from the requirement of a tolerance, or food additive regulation in accordance with 40 CFR 180. Alternatively you may 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. D. WHO TO CONTACT FOR ADDITIONAL INFORMATION Please contact the appropriate Product Manager for your pesticide if you have any questions such as whether an experimental use permit is required, whether a temporary tolerance is required for the proposed use, the appropriate fee, how to submit the application for an experimental use permit, or data required to support the application. If you have questions concerning the testing of "novel" microbial pesticides and/or transgenic plants you should contact Product Manager 18 for insecticide products and Product Manager 21 for fungicide or herbicide products. If the EUP is for a new chemical which has not been assigned to a Product Manager, you should contact the appropriate Deputy Branch Chief, or Branch Chief for a Product Manager assignment. Refer to Chapter 18 of this manual for a listing of the various Product Managers, Deputy Branch Chiefs and Branch Chiefs. E. REFERENCES CITED IN CHAPTER 9 - Refer to Chapter 16 for information on the source of these documents. 1. Code of Federal Regulations, Title 40 Part 152 - Pesticide Registration and Classification Procedures Part 158 - Data requirements for registration Part 172 - Experimental use permits 2. Federal Insecticide, Fungicide and Rodenticide Act, as amended October, 1988. Section 3 - Registration of pesticides 3. Federal Food Drug and Cosmetic Act Section 408 - Tolerances for pesticide chemicals in or on raw agricultural commodities Section 409 - Food additives 4. PR Notice 86-5 - Standard Format for data submitted under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and certain provisions of the Federal Food, Drug and Cosmetic Act (FFDCA). Issued July 29, 1986. 5. PR Notice 89-3 - Format standards for Reregistration Phase 3 summaries and reformatted versions of studies previously submitted under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and certain provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). Issued December 20, 1989. APPENDIX 9-1 EXPERIMENTAL USE PERMIT SUMMARY WORKSHEET COMPOUND: TOTAL ACRES: POUNDS A.I. REQUESTED: NUMBER OF APPLICATIONS (By Site): | SITE 1 / | SITE 2 / | SITE 3 / | SITE 4 / | | TOTAL | | | | | TOTAL | LB. AI STATE| ACRES | ACRES | ACRES | ACRES | ACRES |SHIPPED AL | | | | | | AR | | | | | | AZ | | | | | | CA | | | | | | CO | | | | | | DE | | | | | | FL | | | | | | GA | | | | | | HI | | | | | | IL | | | | | | ID | | | | | | IA | | | | | | KS | | | | | | KY | | | | | | LA | | | | | | MA | | | | | | ME | | | | | | MD | | | | | | MI | | | | | | MN | | | | | | MO | | | | | | MS | | | | | | MT | | | | | | NE | | | | | | NV | | | | | | NM | | | | | | NY | | | | | | NC | | | | | | ND | | | | | | NH | | | | | | NJ | | | | | | OH | | | | | | OK | | | | | | OR | | | | | | PA | | | | | | RI | | | | | | SC | | | | | | SD | | | | | | TN | | | | | | TX | | | | | | UT | | | | | | VA | | | | | | WA | | | | | | WI | | | | | | WV | | | | | | WY | | | | | | | | | | | | TOTALS: | | | | | 9-9