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Pesticide Registration Manual:
Chapter 12 - Applying for an Experimental Use Permit

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Current as of October 2010

In this Chapter:

Introduction to Experimental Use Permits

This chapter describes the all requirements for Experimental Use Permits (EUPs), and includes how to apply for an EUP, labeling requirements, application format, and data reporting requirements.

EPA requires that a pesticide product undergo extensive chemical, toxicological, and field-testing before being registered as a pesticide. Some testing is done under field conditions using commercial application equipment to fully understand the pesticide’s chemical properties, safety, and efficacy.

Because testing undertaken as part of the registration process necessarily involves an unregistered product or is for a use not previously approved in the registration of the pesticide, EPA sometimes must first authorize the distribution and sale for testing purposes by means of an experimental use permit (EUP) under FIFRA section 5 (PDF).

The EUP establishes limited conditions for the transportation, application, and disposal of the pesticide material used in the tests.  Pesticides registered under an EUP may not be sold or distributed other than through approved participants in the test program, and use is limited to the conditions specified in the EUP. Please refer to 40 CFR Part 172 for detailed information on EUPs.

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Requirements for an Experimental Use Permit

A first step for the applicant is to determine whether an EUP is required for the particular testing being considered.  If the product is not intended to be used as a pesticide, an EUP would not be needed to test the product. Additionally, certain pesticide testing operations may not require an EUP if the criteria of 40 CFR 172.3 (PDF) (2 pp, 146.50 k About PDF) are met, as discussed below.

In general, EUPs are issued for:

However, there are certain tests and circumstances that are exempt from the requirements of an EUP because they are presumed not to involve unreasonable adverse effects. These exemptions are summarized below and described in detail in 40 CFR 172.3(b) and (c) (PDF) (2 pp, 146.50 k About PDF).

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Exemptions from EUP Requirements

EPA generally will not require an EUP for a substance or mixture of substances if the EUP is limited to:

The exemptions described above are not definitive. 40 CFR 172.3 (PDF) (2 pp, 146.50 k About PDF) gives EPA discretionary authority to exempt particular testing operations from the EUP requirements under other conditions, as well as allowing EPA discretionary authority to require EUPs for testing operations even when the exemption conditions of 40 CFR 172.3(b) and (c) (PDF) (2 pp, 146.50 k About PDF) are met.

Important Note: EUPs are required for testing of pesticides indoors, as well as in outdoor agricultural settings. This includes testing pesticides to control roaches in domestic dwellings and institutions, and for field-testing of swimming pool sanitizers and disinfectants under actual use conditions.

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EUPs for Nonagricultural and Certain Antimicrobial Uses

EUPs are generally required for testing of pesticides indoors, some non-agricultural uses as well as in outdoor agricultural settings. This includes testing pesticides to control roaches and other insects in domestic dwellings and institutions, control termites in and around structures and buildings, control invasive species, and control birds and animals. EPA will determine on a case-by-case basis when an EUP will be required in these situations in accordance with 40 CFR 172.3(e). Applicants should contact the appropriate registration ombudsman who will consult with appropriate staff to determine whether an EUP will be required.

EUPS are required for field-testing of swimming pool sanitizers and disinfectants under actual use conditions. 40 CFR 172.3(c)(2) states that an EUP is not required for a small scale test conducted on a cumulative total of no more than one surface acre of water per pest with several exceptions including that the treated body of water cannot be used for irrigation, drinking water supplies, or body contact through recreational activities. However, a swimming pool disinfection/sanitization use requires an EUP because the efficacy testing required to support the use involves in-use field testing in at least two swimming pools. There are numerous factors that influence the concentrations necessary for disinfection of swimming pool water in practical applications such as the numbers of swimmers in the pool, frequency of use, frequency with which water is changed, general weather conditions, types and degree of organic contamination of the water by the swimmers themselves (e.g., suntan lotions and oils) and other types of debris. These factors need to be considered when evaluating the effectiveness of a swimming pool sanitizer or disinfectant. Thus, the efficacy data required to support a swimming pool disinfection/sanitization use consists of a two-phased study (laboratory testing and field testing). The EUP application should include an efficacy protocol that describes in detail all tests and step-by-step procedures that are proposed for the in-use swimming pool field tests. Guidance for field testing water that the public may come into contact with through recreational activities such as swimming in pools and spas, is located in the Pesticide Assessment Guidelines Subdivision G, Section 91-8(c) . Applicants should also consult the Antimicrobial Policy Document, “Disinfectant Technical Science Section (DIS/TSS)12”.

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EUPs for Small-Scale Field Testing of Microbial Pesticides

Because of concern about the potential for microorganisms to reproduce and multiply in the environment and the potential for these microbials to cause unforeseen adverse impacts, the Agency may require an EUP for small-scale field-testing of certain microbial pesticides (i.e., genetically altered and nonindigenous microbial pest control agents).

Before the initiation of certain small scale testing involving genetically altered or nonindigenous microbial pest control agents, the research organization, company, or individual must submit a notification to EPA so a determination can be made as to whether an EUP is required. 40 CFR 172.43-59 (PDF) (2 pp, 146.56 k About PDF) presents the requirements for an EUP for field-testing of microbial pesticides. Note that these differ significantly from the EUP requirements for testing other pesticides.      

Applicants should also refer to Chapter 3 of this document for a more detailed discussion of the Agency's policy and requirements for small‑scale field-testing for microbial pesticides.

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Applying for an EUP

An application for an EUP may be submitted by any company or person wishing to generate information necessary to register a product under FIFRA as per 40 CFR 172.2(a) (PDF) (1 pp, 143.46 k About PDF) . The applicant may be a potential registrant, an independent researcher or testing laboratory, or any similar agent or consultant of a manufacturer. Applications must be submitted to the appropriate address given in Chapter 21.

EPA Form 8570-17 (PDF) (2 pp, 262k), Application for Experimental Use Permit, must be submitted to EPA with each EUP application. The type of information to be submitted with the application depends on whether the product is already registered and whether a tolerance is required for the testing covered under the EUP.  40 CFR 172.4(PDF) (2 pp, 146.41 k About PDF) lists the information required in each case.

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Information Required in All EUP Applications

Each EUP application must contain the following information together with a completed copy of EPA Form 8570-17, Application for Experimental Use Permit, and five copies of the proposed labeling (refer to the Labeling Requirements section of this chapter):

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Information Required When the Product to be Tested is Not Already Registered

In addition to the information listed immediately above, when the product to be tested has not been registered, the applicant must provide the following information:

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When Testing May Result in Pesticide Residues on Food

When the product to be tested is to be used in such a manner as to leave residue on food or feed, the applicant has three options regarding tolerances:

Important Note: The Agency review process is greatly facilitated if applicants include a table indicating the states to which the product is to be shipped, the pounds of product to be shipped to each state for each pest or pest complex, and the total pounds of product to be shipped to each state. Also note that if the participants change, the permit needs to be modified (40 CFR 172.4(iv)).

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Labeling Requirements

40 CFR 172.6 (PDF) (1 pp, 142.43 k About PDF) requires that all pesticides shipped or used under an experimental use permit must be labeled with directions and conditions for use, including the following:

In the case of a registered pesticide, EPA may permit a pesticide to be used under an experimental use permit with approved supplemental labeling.

Note: Please refer to Chapter 2 for more information on label and labeling formats.

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Fee Requirements

Refer to Chapter 5 for detailed information on fees.

Based on legislative requirements, fees are assessed for specific EPA review actions for conventional chemical pesticides, antimicrobial products, and biological products. In return, EPA is obligated to perform certain review functions and make regulatory determinations within a specific timeframe.

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Suggested Format for an Experimental Use Permit Application

The following format is an example of an acceptable EUP application. Please note that all of the items are not necessary in every case. Depending on whether the product being tested is already registered with EPA, and whether a tolerance is necessary because treated crops will be used as food or feed, several of these entries may not be necessary. See the section earlier in this chapter entitled “Applying for an EUP” for an explanation of what information is required in each of these situations.

Section A

This section should include a data sheet detailing the chemical and physical properties of the test chemical along with a complete statement of the names and percentages by weight of each active and inert ingredient in the formulation to be shipped. The Confidential Statement of Formula, EPA Form 8570-4 (PDF) ( 2 pp, 1.1 MB) can be used for some of this information.

Section B

This section should include a copy of the proposed experimental label. The minimum labeling requirements are set forth in 40 CFR 172.6 (PDF) (1 pp, 142.43 k About PDF) .

Section C

This section should include toxicity data, including oral and dermal LD50 values, inhalation LC50 values, and eye and skin irritation data for the formulated product, as well as subchronic toxicity, developmental toxicity (one species), mutagenicity, and potentially, chronic toxicity and reproduction data on the active ingredient. Data on the product’s toxicity to fish and wildlife may also be included in Section C, as appropriate (40 CFR Part 158 and for antimicrobial pesticides, 40 CFR Part 161).

Section D

This section should include residue data, including, when appropriate, data on: (1) food or feed commodities; (2) nonfood crops such as tobacco; or (3) foliage or other sites where the product may be used and on which remaining residues of the product may pose a risk to humans or the environment. Section D also includes a description of the analytical methods used, a summary of the residue data acquired, and when appropriate, environmental fate data.

Section E

This section should include product performance information demonstrating that the product is useful for the purposes proposed. Because EPA has waived the requirement for submitting efficacy data for all products except those with public health uses, Section E need not contain actual efficacy data, but should include a summary of the results of all efficacy testing performed on the product.

Section F

This section should include a statement explaining whether a tolerance exists or is being requested, especially if the product is to be tested in a manner that may result in residues in food or feed. If a tolerance is being requested, the temporary tolerance petition must be provided with the EUP application. Whenever all food or feed derived from the experimental program is to be destroyed or fed to experimental animals, a statement must be included explaining this.

Section G

The section should include details concerning the proposed experimental program, including:

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Extensions or Renewal of Experimental Use Permits

EUPs 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. The written request should include an explanation/justification for requesting the extension/renewal/amendment. Please note that the Agency processing time may, in certain circumstances, be similar to new EUPs. The applicant must request an amendment to an EUP if one or more of the following changes are requested:

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Program Surveillance and Data Reporting Requirements for an Experimental Use Permit

Once the permit is issued and the pesticide testing is under way, the applicant is required to track the results at each test site and submit to EPA within 180 days after the expiration of the permit a final report that shall include (40 CFR 172.8 (PDF) (2 pp, 146.52 k About PDF) ):

EPA, as well as the state, may require advance notice from the applicant of the intended test dates, sites, and times. The applicant must also allow EPA and state access to the testing site to determine whether the testing complies with the terms and conditions of the permit.

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References Cited in Chapter 12

Refer to Chapter 19 for information on the source of these documents.

Code of Federal Regulation, Title 40

Federal Insecticide, Fungicide, and Rodenticide Act (PDF), as amended by the Food Quality Protection Act of August 3, 1996

Federal Food, Drug and Cosmetic Act Exit EPA disclaimer

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)

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