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SUPPORTING STATEMENT FOR 

AN INFORMATION COLLECTION REQUEST (ICR) 

1. IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) Title of the Information Collection

Title: Experimental Use Permits (EUPs) for Pesticides

 

OMB No. 2070-0040 EPA No. 0276.14 

1(b) Short Characterization/Abstract 

This Information Collection Request (ICR) is a renewal of an existing ICR that is 

currently approved by OMB and is due to expire November 30, 2010. The information 

collection provides EPA with the data necessary to determine whether to issue an experimental 

use permit (EUP) under section 5 of the Federal Insecticide, Fungicide, and Rodenticide Act 

(FIFRA) (Attachment A, pp. 58-59). FIFRA requires that before a pesticide product may be 

distributed or sold in the U.S., it must be registered by EPA. However, FIFRA section 5 

authorizes EPA to issue an EUP to allow pesticide companies to temporarily ship pesticide 

products for experimental use for the purpose of gathering data necessary to support the 

application for registration of a pesticide product. In general, EUPs are issued either for a 

pesticide not registered with the Agency or for a new use of a registered. 

The information collected and reported under an EUP is a summary of that which is 

routinely submitted in connection with registration. The EUP allows for large scale field testing, 

if necessary, in order to collect sufficient data to support registration. An EUP is not required if 

the person conducting the tests does not expect to receive benefits in pest control. 

The prospective registrant files EPA Form 8570-17, Application for An Experimental 

Use Permit to Ship and Use a Pesticide for Experimental Purposes Only (see Attachment B) for a 

permit to generate information or data necessary to register a pesticide under Section 3 of 

FIFRA. This information from the applicant is necessary in order to grant and effectively 

monitor the EUP. The applicant must also provide the Agency with a final report on the results 

of the experimental program which includes information such as: amount of the product applied; 

the crops or sites treated; any observed adverse effects; any adverse weather conditions which 

may have inhibited the program; the goals achieved; and the disposition of containers, unused 

pesticide material, and affected food/feed commodities. 

If the food/feed treated under the terms of an EUP is to be shipped in commerce, the 

applicant must also submit a petition for temporary tolerance pursuant to section 408 of the 

Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a). The information collection 

activities associated with tolerances are addressed in a separate ICR (EPA ICR #597), which is 

approved by OMB under OMB Control Number 2070-0024. As such, tolerance related activities 

are not described in this ICR. 
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2. NEED FOR AND USE OF THE COLLECTION

2(a). Need/Authority for the Collection 

As required by section 5 of FIFRA, and Part 172 of Title 40 of the Code of Federal 

Regulations (40 CFR Part 172), the information collected and reported is necessary to evaluate 

the potential hazard of the product and to make certain that the permit was issued for genuine 

experimental purposes rather than as a form of temporary registration. (See Attachment C for a 

link to the regulations). To ensure compliance, the final report is compared with the objectives 

of the testing program. The information also enables EPA to identify whether the treated food or 

feed crops will be used in a commercial market. Such use would require issuance of a temporary 

tolerance or destruction of the crop because the use was for research purposes only. Since it is 

common for applicants to request extensions of EUPs, it is imperative that the Agency has 

reports in hand in order to judge the need for such extensions. 

Exemptions from EUP requirements:

Under the existing EUP regulations, small-scale experimental uses of pesticides are 

presumed exempt from the EUP requirements. EPA will not require an EUP for a substance or 

mixture of substances being put through laboratory or greenhouse tests, or fewer than one 

surface acre per pest for terrestrial tests or fewer than ten acres per pest for aquatic tests, in 

which the sole purpose under the following small scale field testing scenarios: 

Land-Pesticide testing on plots of land ten acres or less in size:

Test plots may be as large as ten acres per pest if the effect of each pesticide on several 

pests is being investigated at a different time for each pest. However, if pesticide effects on 

more than one pest are being investigated all at the same time, the test plot may not exceed ten 

acres in size. Furthermore, any food or feed crops involved in or affected by the tests must be 

destroyed or consumed only by experimental animals unless a tolerance or exemption from a 

tolerance has been established. 

Aquatic Uses-Pesticide testing on water bodies one surface acre or less in size: 

Water bodies may be as large as one acre per pest if the effect of each pesticide on 

several pests is being investigated at a different time for each pest. However, if pesticide effects 

on more than one pest are being investigated all at the same time, the water body may not exceed 

one acre in size. Bodies of water involved in or affected by the tests may not be used for 

irrigation, drinking water supplies, or body contact through recreational activities. In addition, 

pesticides may not be tested in waters that contain or which affect any fish, shellfish or other 

plants or animals which may be taken for food or feed unless a tolerance or exemption from 

tolerance exists for the test product. 

Animal Treatment Uses: 

Tests may be conducted only in cases where experimental animals will not be used for 

food or feed unless a tolerance or exemption from tolerance exists for the test product. 
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Other Uses:

In instances where testing operations do not accurately reflect whether the testing is to be 

considered small-or large-scale acreage limits, the Agency will determine on a case-by-case 

basis whether an exemption from the requirement from an EUP is appropriate. 

The exemptions described above are not definitive, but 40 CFR 172.3 gives EPA 

discretionary authority to exempt particular testing operations from the EUP requirements under 

other conditions. 40 CFR 172.3 also allows EPA discretionary authority to require EUPs for 

testing operations even when the exemption conditions of 40 CFR 172.3(b) and (c) are met. 

EUP for Small-scale Field Testing of Microbial Pesticides:

The Agency may require an EUP for small scale field testing of certain unique microbial 

pesticides (i.e., genetically-altered and non-indigenous microbial pest control agents) because of 

the potential concern for microorganisms to reproduce and multiply in the environment and the 

potential for these microbial pesticides to cause unforeseen adverse impacts. Prior to the 

initiation of any small scale field testing involving 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. 

The requirements for a EUP for field testing of microbial pesticides are found in 40 CFR 

172.43-172.59. These requirements differ significantly from the EUP requirements for testing 

other pesticides. 

2(b). Practical Utility/Users of the Data 

The information collected and reported under an EUP will enable the Agency to: 

 Determine whether a new request for an EUP or a renewal, extension or amendment 

of an EUP, if requested, is justified; 

 allow for adequate monitoring of the EUP program; and 

 ascertain the cause/effect relationship when a pesticide is registered and later found to 

have adverse effects (as in the case of phytotoxicity); and 

 allow the Agency to review efficacy data which may contain important health data. 

3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION 

CRITERIA

3(a). Non duplication 

The respondent is not required to submit EUP-related information or data to any other 

Federal agency or to any other EPA program offices. FIFRA section 7, however, does require 

annual pesticide production reports from all persons who produce pesticides (see Attachment A, 

p. 65). The pesticide material produced in conjunction with an EUP would be included in these 
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annual production reports; however, annual production information is not required as a condition 

of the EUP, only total production in the final report. 

3(b). Public Notice Required Prior to ICR Submission to OMB 

Pursuant to 5 CFR 1320.8(d), EPA published a Federal Register (FR) Notice announcing 

this proposed information collection activity and providing a 60-day public comment period (75 

FR 9594; March 3, 2010) (a copy of this FR document is available in the docket for this ICR). 

The Agency did not receive any public comments. 

3(c). Consultations on this Renewal ICR 

In the context of an individual EUP, consultation and/or dialogue between the respondent 

and EPA occurs on an informal, ongoing "as needed" basis, primarily during the submission and 

review of the application for an EUP. Historically, when technical, administrative or other 

problems arise, the respondent is given ample opportunity to inform the agency and vice versa. 

This communication between both parties may take place either in a telephone conversation or in 

a meeting setting, but not necessarily by a prescribed schedule. 

In addition, as required under 5 CFR 1320.8(d)(1), EPA staff contacted several 

representatives of pesticide registrants by e-mail to seek feedback on the EUP information 

reporting requirements and the regulatory burden estimates expressed by the Agency in this ICR. 

The list of representatives and the questions posed is provided in Attachment D. 

The Agency received responses from Monsanto Company and Syngenta Biotechnology, 

Inc. (see Attachment E). Monsanto indicated that, based on their experience with the time 

needed to assemble and format the data to fulfill Pesticide Registration (PR) Notice 86-5 

requirements (Attachment F), their EUP paperwork burden is significantly higher both for 

chemical pesticides and for plant-incorporated protectants (PIPs) than the estimates provided in 

the first public review draft of this ICR. In response to this feedback, the burden estimates 

provided by Monsanto for chemical pesticides have been incorporated into the estimates 

provided in section 6 of this ICR, to derive the current paperwork burden estimates per EUP 

application. 

 In addition to their overall higher paperwork burden estimates for EUP applications, 

Monsanto’s estimates for PIP EUP applications involving PIPs, are notably higher than those for 

chemical pesticides. PIPs are pesticidal substances produced by plants and the introduced 

genetic material with the desired pesticidal trait necessary for the plant to produce the substance 

(for more information about PIPs, go to 

http://www.epa.gov/oppbppd1/biopesticides/pips/#science ). Monsanto’s estimates for PIP EUP 

applications involving PIPs, include the time it takes them to prepare and format the different 

combinations of acreage and active ingredient calculations that they say are required to be 

broken down in different ways (i.e., by protocol tables, by PIP tables, etc.). 

As PIP EUPs have increased in complexity due to the testing of multiple stacked traits 

under a single EUP, EPA has not required an EUP for each trait combination, but has allowed 

individual and trait combinations related to the development of novel trait or use to be lumped 

under one EUP. This approach has actually provided a cost-savings for EUP applicants, 
September 30, 2010 

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allowing them to submit one EUP when EPA could require ten or more times that amount (33 in 

one case). Therefore, Monsanto’s increased time estimates for this particular activity are not 

necessary representative of typical burdens for EUP applications per PIP trait. 

However, since requirements for field testing of pesticides are substantially different for 

PIP EUP applications and tend to be more intensive than for chemical pesticides, they can 

require more time to prepare and to submit the information. In addition, over the past ten years, 

the Agency has increasingly received a higher percentage of EUP applications for PIP (on a traitby-trait basis) than for chemical pesticides. As a result, in this ICR, applications for PIP EUPs 

have been treated as a separate response type from those for chemical EUPs. For the 2010 

renewal cycle of this ICR, the second response type (PIP) will use Monsanto’s estimates as these 

are the only numbers available to the Agency at this time. 

Another part of the response from Monsanto also pointed out that the fully loaded labor 

rates provided in the ICR are too low. However, they provided no further details. In section 6 of 

this ICR, the same fully loaded labor rates for NAICS code 325300 has been used both for 

chemical and biological pesticide manufacturers. 

Syngenta commented in general terms on the complexity of the PIPs application process 

but did not give specific explanations. 

3(d). Effects of Less Frequent Collection 

There is only one submission required in conjunction with each request for EPA approval 

to conduct testing on certain pesticides. Therefore, the frequency of the collection cannot be 

reduced, except to eliminate the collection altogether. The Agency then would have no means 

by which to evaluate the potential human health risks and environmental hazard presented by a 

proposed test. 

3(e). General Guidelines 

The only guideline under the Paperwork Reduction Act (PRA) that is exceeded in this 

collection is the time period for retaining records. EPA requirements in 40 CFR 169.2(k) state 

that records containing research data relating to registered pesticides be retained as long as the 

registration is valid and the manufacturer remains in business. Pesticide registrations are valid 

until they are either voluntarily canceled or withdrawn by the registrant or until EPA has cause to 

suspend or cancel the registration. Since the average period of marketability of a pesticide 

ranges from 15 to 30 years, the PRA guidelines specifying that data other than health, medical, 

or tax records not be required to be retained for more than three years will be exceeded in this 

program. 

3(f). Confidentiality 

When trade secret information or Confidential Business Information (CBI) is provided to 

the Agency, such information is protected from disclosure under FIFRA Section 10, as amended 

and EPA's confidentiality regulation in 40 CFR Part 2, Subpart B. Data submitted to the Agency 

are handled strictly in accordance with the FIFRA CBI Security Manual. This manual contains 

instructions relative to all contact with confidential documents, including responsibility of EPA 
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employees; physical security measures; CBI materials within EPA, such as CBI typing 

procedures (documents typed internally or on contract); and division internal procedures. The 

manual dictates that: (1) all CBI must be marked or flagged as such, (2) all CBI must be kept in 

secure, double-locked areas, and (3) all CBI for destruction must be cleared by a document 

control officer and placed in the Office of Chemical Safety and Pollution Prevention paper 

shredder. 

3(g). Sensitive Questions 

No information of a sensitive or private nature is requested in conjunction with this 

information collection activity. Further, this information collection activity complies with the 

provisions of the Privacy Act of 1974 and OMB Circular A-108. 

4. THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a). Respondents/NAICS Codes 

 The North American Industrial Classification System (NAICS) code for respondents 

participating in this data collection is 325300 (Pesticide Registrants). 

4(b). Information Requested 

4(b) (i) Data Items 

Form 8570-17 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 lists the information that is required. 

An application for an EUP may be submitted by any company or person wishing to 

generate the information necessary as required by section 3 of FIFRA in accordance with the 

regulations found in 40 CFR 172.2(a). 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 following address: 

Document Processing Desk (EUP) 

U.S. Environmental Protection Agency 

Office of Pesticide Programs (7504P) 

U.S. Environmental Protection Agency 

1200 Pennsylvania Ave. NW 

Washington, D.C. 20460 

Information Required in All EUP Applications:

Each EUP application must contain the following information together with a completed 

copy of 8570-17: 
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 Applicant’s name and address; 

 The registration number of the product, if it has been registered (information 

requirements for unregistered products are listed below in a separate section); 

 Purpose or objectives of the proposed testing; 

 Detailed description of the proposed testing program including the following test 

parameters: 

 Pest organism(s) involved; 

 Amount of pesticide proposed to be used; 

 Crops, fauna, and flora involved; 

 Sites and modes of pesticide applications; 

 Pesticide dosage rates; 

 Location of test site, including States; 

 Number of acres in test site; 

 Number of structural sites or number of animals by State to be included in the 

testing; 

 Proposed dates of the testing; and 

 How the testing will be supervised. 

 Name, street address, telephone number and qualifications of program participants, 

including those not employed by the applicant; 

 Names and street addresses of cooperators (persons owning or controlling application 

sites and granting permission to permittees to use these sites); 

 Results of prior testing of product by applicant to determine: 

 toxicity and effects in or on target organisms; 

 toxicity and effects in or on non-target plants, animals and insects at or near the 

application site; and 

 adverse effects to the environment from application of this product; and 

 how the applicant intends to store and dispose of unused pesticide and containers 

from the proposed experimental use. 

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

New data required to be submitted for EUP applications for field testing of both 

unregistered chemical and plant-incorporated pesticides (PIP) to show that the pesticide during 

testing will not cause an unreasonable adverse effect to man and the environment are 

substantially greater than registered pesticides that have already met these requirements of 

FIFRA for their labeled uses. 

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: 

 A complete confidential statement of composition giving the composition of the 

formulation to be tested as a tabulation of the names and percentage by weight of each 

ingredient, both active and inert; 

 Chemical and physical properties of each active ingredient of the formulation being 

tested including the analytical methods to be used to determine these; 

 Available data on the rate of decline of residues on the treated crop or site together with 

other information relevant to determining when workers can safely re-enter treated areas; 

and 
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 Available toxicity and exposure data, including human epidemiological data, relevant to 

assessing the potential of the product to cause injury to users and other people who may 

be exposed. 

When Testing May Result in Pesticide Residue on Food:

 When the product to be tested is to be used in such a manner to leave residue on food or 

feed, the applicant has three options for determining that treated crops are not used for food or 

feed use without a tolerance: 

 The applicant may submit evidence that a tolerance or a tolerance requirement exemption 

has been established under Section 408 of the FFDCA; 

 The applicant may submit a petition for a new tolerance or for an exemption from the 

requirement for a tolerance established under Section 408 of the FFDCA (Chapter 7 of 

this document, Tolerance Petitions, describes this process in detail); and 

 The applicant may certify that the food or feed derived from the experimental program 

will be destroyed or will be fed only to experimental animals which will be destroyed. 

Alternatively, the applicant may certify that the food or feed derived from the 

experimental program will be disposed of in another manner which does not endanger 

man or the environment; the permit application shall specify the means of such disposal. 

EUP applications should be submitted to EPA as far in advance as possible of the first 

shipping date, at least six months in advance. FIFRA section 5(a) requires EPA to complete 

EUP reviews within 120 days, and failure to provide the appropriate information or data may 

delay processing of the EUP beyond this date. 

Labeling Requirements:

All pesticides shipped or used under an EUP must be labeled with directions and 

conditions for use including the following: 

 The prominent statement “For Experimental Use Only”; 

 The Experimental Use Permit Number; 

 The statement “Not for sale to any person other than a participant or cooperator of the 

EPA-approved Experimental Use Program”; 

 The name, brand or trademark; 

 The name and address of the permittee, producer, or registrant; 

 The net contents; 

 An ingredient statement; 

 Warning or caution statements; 

 Any limitations on entry of persons into treated areas; 

 The establishment registration number, except in those cases where application of the 

pesticide is made solely by the producer; and 

 The directions for trial use. 
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Extensions or renewal of EUPs:

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. 

Fee Requirements:

If an application for an EUP 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. An extension or renewal request for a 

temporary tolerance is also subject to a fee requirement. In March 2004, the Pesticide 

Registration Improvement Act (PRIA) of 2003 became effective. The goal of this Act is to 

create a more predictable evaluation process for affected pesticide decisions, and couple the 

collection of individual fees with specific decision review periods. The legislation also promotes 

shorter decision review periods for applications including reduced-risk. Certain submitted EUP 

actions are included under PRIA and the burden hours and costs associated with these activities 

are estimated in the Pesticide Registration Fee Waivers ICR, (OMB Control No.: 2070-0167, 

EPA ICR No.: 2147), and are not duplicated in this ICR. 

Use of an EUP Product on Food or Feed Crops:

A product may only be used on food or feed crops if the Agency has issued tolerances or 

exemptions from requirements for tolerances for all inert ingredients, metabolites, and 

degradation products, as well as active ingredients. If the 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, applicants 

must submit a statement indicating whether a tolerance or an exemption from the requirement of 

a tolerance has been issued by the Agency under section 408 of the FFDCA. 

If a tolerance, exemption from the requirement of a tolerance has not been issued for such 

residues, applicants must include with the application 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, applicants 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. 

Suggested Format for an EUP Application:

The following format is an example of an acceptable EUP application. Not all of the 

items are 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. 

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. 
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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. 

Section C - This section should include toxicity data, including LD50 values, eye and 

skin irritation data for the formulated product, and subacute, teratology (one species), 

mutagenicity, and possibly chronic 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. 

Section D - This section should include residue data, including when appropriate, data 

on: (1) food or feed commodities; (2) non-food 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 man 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. Given the occurrence whenever all food or feed derived 

from the experimental program is to be destroyed or fed to experimental animals, a statement of 

explanation must be included. 

 

Section G - The section should include details concerning the proposed experimental 

program, including: 

 qualifications, names, addresses and telephone numbers of all EUP participants, 

including cooperators, i.e., persons who grant permission for an experimental use 

pesticide to be used on application sites which they own or control; 

 names of states in which the product will be used, along with the amount of active 

ingredient and acreage (or other appropriate measures) to be used in each state, and the 

names of states in which the pesticide may be shipped for further distribution; 

 details of the proposed EUP program, including types of pests or organisms targeted; the 

crops, animals, surface, or sites to be treated; the geographical areas where the material is 

to be used; the use patterns, intended plot sizes, number of plots, number of replicates, 

and other test parameters to be used; 

 information on prior testing, including 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 any target organisms at the site of application; phytotoxicity and 

other forms of toxicity or effects on nontarget plants, animals and insects, at or near the 

site of application ; or any adverse effects on the environment; 

 objectives of the EUP program, including a statement specifying the type of data to be 

collected and the intended gain from conducting the program; 
September 30, 2010 

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 justification for the quantity (volume) of active ingredient proposed to be used under the 

EUP, including a statement specifying the various parameters used to determine the 

quantity of active ingredient; 

 a statement proposing a suitable duration for the EUP commensurate with the program 

objectives; and 

 details concerning the method of disposing of unused materials at the conclusion of the 

testing program. 

Program Surveillance and Data Reporting Requirements for an EUP:

Once the permit is issued and the pesticide testing is underway, the applicant is required 

to track the results at each test site and submit a final report to EPA which shall include (40 CFR 

172.8): 

 All data gathered during the testing program. Although field notes need not be included 

in this report, they must be kept available for EPA review upon request. 

 A report of how pesticide containers and unused pesticides were disposed of, including 

the quantity disposed of, disposal sites and disposal methods. 

 In the case where meat-producing animals or birds are treated by or exposed to an 

experimental use pesticide, the applicant must report the name and location where the 

animals will be processed to the U.S. Department of Agriculture, Animal and Plant 

Health Inspection Service, Washington, DC, 20250. 

 The applicant must also report any adverse effects from use of or from exposure to the 

pesticide being tested. 

EPA may require advance notice from the applicant of the intended test dates, sites and 

times. The applicant must also allow EPA access to the testing site to determine whether the 

testing complies with the terms and conditions of the permit. 

4(b) (ii) Respondent Activities 

 The following are the activities to be conducted by a respondent (applicant) in order to 

comply with the provisions of EPA Form 8570-17. 

Activity Explanation 

read FIFRA Section 5 

and 40 CFR 172.8(b) 

become familiar with the legislation and regulations and determine 

the requirements as they pertain to a proposed experimental use of 

a pesticide 

plan activities plan the actions necessary to comply with the legislation and 

regulations 

create information develop information required for notification 

gather information gather information required for the notification or containment 

records 

process, compile, and review information check information for accuracy and completeness 

complete paperwork prepare notification document or containment record 

record, disclose, and display information submit notification to OPP 

store, maintain, and file information retain copies of all submissions 
September 30, 2010 

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5. THE INFORMATION COLLECTED – AGENCY ACTIVITIES, COLLECTION 

METHODOLOGY, AND INFORMATION MANAGEMENT

5(a). Agency Activities 

 The following are activities necessary to evaluate a submitted request for an EUP: 

5(b). Collection Methodology and Management 

A submitted EUP package usually includes three parts: an EPA Application Form 8570-

17, the product label, and, in most cases, supporting data. The application form and the product 

label are pin-punched by date by the Front-End Application Processing Unit for initial screening. 

If everything is found to be complete, the proposed EUP is given a file symbol, entered into the 

appropriate tracking system, and a registration jacket is created identifying the document by the 

appropriate Product Manager (PM) for the chemical being employed. The accompanying data is 

identified and processed for review. 

The three-part EUP package is sent to the designated PM who is responsible for 

managing the registration action. The testing program and labeling program are reviewed by the 

PM while the data portion is routed for scientific review to the appropriate discipline. On 

completion of the scientific review, the PM receives a written analysis of the data. If the data is 

found to be acceptable, an EUP is issued. If not, the EUP request is rejected and the PM then 

notifies the applicant in writing of the deficiencies before the EUP request can be resubmitted. 

The file is then updated in the tracking system to reflect the latest status and the registration 

jacket is stored in the file room. 

5(c). Small Entity Flexibility 

The Agency recognizes that many small businesses are involved in research and 

development activities with pesticides. In setting forth the notification requirements, EPA has 

sought to minimize the regulatory burden on research and development activities. Toward this 

end, the Agency has identified the minimum amount of data to be submitted to permit a scientific 

assessment of the proposed research. Much of this information already would be available to the 

respondent as part of the normal information developed during the research and development 

stage. These data requirements are flexible and may be adjusted as appropriate to the specific 

product under review. As an alternative to submitting a Notification, an applicant may apply for, 

and obtain an EUP before conducting a field test with a pesticide. Because the notification 

Activity Explanation 

review submitted application package review application form and package for completeness and 

appropriateness 

record submission record submission in tracking system 

analyze submission conduct scientific reviews of data 

file submission store and maintain submission information in Agency’s file 

system 
September 30, 2010 

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requirements have been designed from the outset to minimize the burden on respondents, as a 

result, there are no special measures taken for small businesses since the burden is considered to 

be at a minimal level. 

5(d). Collection Schedule 

Not applicable. This activity is conducted only when an EUP request is made.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a). Estimating the Respondent Burden 

Consultations responses and a review of the Agency process for EUP data submissions 

indicate that the paperwork burden can be significantly higher both for chemical pesticides and 

for plant-incorporated protectants (PIP) than previous estimates. In response, this ICR has made 

changes (an increase in the overall burden, and the creation of a second response type for plantincorporated protectants or PIP) based on respondent’s experience with the time needed to 

assemble and format the data to fulfill PR Notice 86-5 requirements (Attachment F). 

Burden estimates provided through consultations responses for chemical pesticides have 

been incorporated to derive an average figure for the current paperwork burden estimates per 

EUP application for that response type. 

The respondent’s estimates for PIP EUP applications include the time it takes them to 

prepare and format the different combinations of acreage and active ingredient calculations that 

they say are required to be broken down in different ways (i.e., by protocol tables, by PIP tables, 

etc.). 

As PIP EUPs have increased in complexity due to the testing of multiple stacked traits 

under a single EUP, EPA has not required an EUP for each trait combination, but has allowed 

individual and trait combinations related to the development of novel trait or use to be lumped 

under one EUP. This approach has actually provided a cost-savings for EUP applicants, 

allowing them to submit one EUP when EPA could require ten or more times that amount (33 in 

one case). Therefore, Monsanto’s increased time estimates for this particular activity are not 

necessary representative of typical burdens for EUP applications per PIP trait. 

However, as detailed in sections 3(c) and 4(b)(i) of this ICR, requirements for field 

testing of PIP tend to be more intensive than for chemical pesticides, resulting in more time to 

prepare and submit the information. Moreover, over the past ten years, the Agency has 

increasingly received a higher percentage of PIP EUP applications than EUPs for chemical 

pesticides (on a trait-by-trait basis). As a result, in this ICR, PIP EUP applications have been 

treated as a separate response type from chemical EUPs. For the 2010 renewal cycle of this ICR, 

the second response type (PIP) will use Monsanto’s estimates as these are the only numbers 

available to the Agency at this time. 

 

Based on the number of EUP applications received in fiscal years 2007, 2008 and 2009, 

the estimated annual number of respondents for chemical pesticides is 10.3 and the estimated 
September 30, 2010 

Page 14 of 18 

number of EUP applications for plant-incorporated protectants is 10.7 for each year of the three 

year renewal cycle. Total respondent burden hours are estimated at 32.8 hours per response for 

chemical pesticides at a cost of $1,942.53 and 147 hours per response for plant-incorporated 

protectants at a cost of $8,858.76. The total annual respondent burden of the EUP program is 

estimated to be 1,907 hours and $114,566. 

6(b) Estimating Respondent Costs 

To determine respondent costs, the Agency used the Bureau of Labor Statistics estimates 

of labor rates for the North American Industry Classification System (NAICS) code for the 

Pesticide Registrants (NAICS 325300). The managerial labor rate is based on the Standard 

Occupational Code (SOC) for management occupations; the technical labor rate is based on the 

SOC for life, physical and social science occupations; and the clerical labor rate is based on the 

SOC for office and administrative support occupations. The labor rates are fully loaded and 

indexed to 2009 dollars. (See Attachment G.) The fully loaded hourly mean wage rate estimate 

for managerial occupations is $118.32 per hour. For technical occupations, the fully loaded 

mean wage rate is $60.88 per hour, and for occupations the fully loaded mean wage rate is 

$37.40 per hour. (See Worksheet for Pesticide Registrants, NAICS: 325300). 

Using the Agency’s burden estimate and the fully-loaded labor rates, the Agency 

estimates the applicant labor costs to be approximately $1,942.53 per chemical pesticide EUP 

response, and $8,858.76 per PIPs EUP response. The total labor cost associated with the 

paperwork burden of the EUP program is estimated to be $114,566. 

RESPONSE BURDEN AND COST ESTIMATES PER EUP APPLICATION FOR 

CHEMICAL PESTICIDES 

COLLECTION 

ACTIVITIES 

BURDEN HOURS (PER YEAR TOTAL 

 Management

$118.32/hr. 

Technical 

$60.88/hr.

Clerical 

$37.40/hr.

Hours Costs 

Read regulations 1.3 1.3 - 2.5 $224.01 

Plan activities - 2.5 - 2.5 $152.21 

Create information - 3.0 2.0 5.0 $257.44 

Gather information - 4.3 4.0 8.3 $408.34 

Compile and review 2.0 6.0 2.0 10.0 $676.74 

Complete paperwork 0.3 0.8 2.0 3.1 $155.95 

Store/maintain data - 0.5 1.0 1.5 $67.84 

TOTAL BURDEN 3.6 18.3 11.0 32.8 $1,942.53 

ANNUAL BURDEN: 32.8 Hours Per Response x 10.3 Responses Per Year = 338.9 Hours 

ANNUAL COSTS 

 (a) Management: 3.6 hours x $118.32 x 10.3 Respondents $4,340 

 (b) Technical: 18.3 hours x $60.88 x 10.3 Respondents $11,482 

 (c) Clerical: 11.0 hours x $37.40 x 10.3 respondents $4,251

 Total $20,073 
September 30, 2010 

Page 15 of 18 

RESPONSE BURDEN AND COST ESTIMATES PER EUP APPLIATION FOR PLANTINCORPORATED PROTECTANTS 

COLLECTION 

ACTIVITIES 

BURDEN HOURS (PER YEAR TOTAL 

 Management

$118.32/hr. 

Technical 

$60.88/hr.

Clerical 

$37.40/hr.

Hours Costs 

Read regulations 2.0 4.0 0.0 6.0 $480.18 

Plan activities 0.0 20.0 0.0 20.0 $1,217.68 

Create information 0.0 40.0 4.0 44.0 $2,584.94 

Gather information 0.0 6.0 8.0 14.0 $664.47 

Compile and review 4.0 40.0 4.0 48.0 $3,058.23 

Complete paperwork 1.0 8.0 4.0 13.0 $754.98 

Store/maintain data 0.0 1.0 1.0 2.0 $98.28 

TOTAL BURDEN 7.0 119.0 21.0 147.0 $8,858.76

ANNUAL BURDEN: 147.0 Hours Per Response x 10.7 Responses Per Year = 1,568 Hours 

ANNUAL COSTS 

 (a) Management: 7.0 hours x $118.32 x 10.7 Respondents $8,835 

 (b) Technical: 119.0 hours x $60.88 x 10.7 Respondents $77,282 

 (c) Clerical: 21.0 hours x $37.40 x 10.7 respondents $8,377

 Total $94,493

 6(c) Estimating Agency Burden and Costs 

For this ICR renewal, the Agency is using data on internal OPP Divisions that provide 

significant support and analysis for the EUP ICR program. This data is taken from the Time and 

Attendance Information System (TAIS), which archives the Agency’s Full Time Equivalents 

(FTEs) for most OPP program activities. The Agency believes that using data from the TAIS 

reflects the changes to the internal operations for implementing and administering EUP 

activities. The major impetus for internal program realignment was to implement the 

requirements of the Food Quality Protection Act of 1996 and the Pesticide Registration 

Improvement Act of 2003 (PRIA) as reauthorized. 

Using this new source of data the estimated number of Agency FTE’s dedicated to EUP 

activities is 0.18 managerial FTE, 1.77 technical FTEs, and 0.11 clerical FTE. Greater detail is 

given in the below tables. The aggregated Agency estimated FTEs dedicated to EUP activities is 

2.05 and, based on 2,080 hours per FTE, the burden hours are 4,271. 

 

Distribution of Agency Managerial FTEs Supporting EUP Activities 

AD BPPD EFED HED RD 

0.01 0.08 0.02 0.06 0.02

Agency total 0.18

Distribution of Agency Technical FTEs Supporting EUP Activities 

AD BPPD EFED HED RD 

0.05 0.85 0.13 0.52 0.21

Agency total 1.77
September 30, 2010 

Page 16 of 18 

Distribution of Agency Clerical FTEs Supporting FIFRA EUP Activities 

AD BPPD EFED HED RD 

0.01 0.06 0.01 0.02 0.02

Agency total 0.11

To determine Agency costs, the Agency used the Bureau of Labor Statistics estimates of 

labor rates for the North American Industry Classification System (NAICS) code for the Federal 

Executive Branch (NAICS 999100). The managerial labor rate is based on the Standard 

Occupational Code (SOC) for management occupations; the technical labor rate is based on the 

SOC for life, physical and social science occupations; and the clerical labor rate is based on the 

SOC for office and administrative support occupations. The labor rates are fully loaded and 

indexed to 2009 dollars. (See Attachment H.) The fully loaded hourly mean wage rate estimate 

for managerial occupations is $112.36 per hour. For technical occupations, the fully loaded 

mean wage rate is $74.47 per hour, and for occupations the fully loaded mean wage rate is 

$42.41 per hour. (See Attachment H, Worksheet for NAICS 999100 EPA or Federal 

Government) 

To calculate the Agency’s estimated annual cost of EUP activities, the number of FTEs 

allocated to EUP activities is multiplied by the cost per FTE. This represents the Agency’s 

estimate of its cost that will result from EUP activities for each of the next three years. 

ANNUAL BURDEN: 2.05 FTE x 2,080 hours per FTE = 4,271 Hours 

ANNUAL COSTS 

 (a) Management: 378 hours (0.18 FTE) x $112.36 = $42,432 

 (b) Technical: 3,673 hours (1.77 FTE) x $74.47 = $273,544 

 (c) Clerical: 220 hours (0.11 FTE) x $42.41 = $9,348

 Total $325,325 

6(d) Bottom Line Hours and Costs / Master Table 

 MASTER TABLE 

TOTAL 

Hours Costs 

Respondent Burden/Cost Estimates: 1,945 $114,566 

Agency Burden/Cost Estimates: 4,271 $325,325 

6(e) Reasons For Changes in Burden 

 

 Annual respondent burden is estimated in this renewal to be 1,945 hours. This is an 

increase from the ICR approved by OMB, which is 757.5 hours. The increase of 1,187.5 hours is 

an adjustment in the burden estimates resulting from consultations with EUP program 

participants, and an estimated number of EUP applications that are for PIPs compared to 

chemical pesticides. Estimated respondent costs have also increased from $48,327 to $114,566. 

The corresponding estimated Agency burden and total costs has also been adjusted 

upwards from 1,125 hours to 4,271 hours, and from $75,199 to $325,325. This is a result of an 

improvement in the data and method used to calculate Agency burden. 
September 30, 2010 

Page 17 of 18 

6(f) Burden Statement 

The total annual “respondent” (applicant) burden for the renewal ICR entitled 

Experimental Use Permit (EUP) for Pesticides is estimated to be 1,945 with an average potential 

per respondent burden of between 32.8 hours for chemical pesticides and 147 hours for plantincorporated protectants. “Burden” is defined in 5 CFR 1320.3(b). The agency may not conduct 

or sponsor, and a person is not required to respond to, a collection of information unless it 

displays a currently valid OMB control number. OMB control numbers for certain EPA 

regulations in title 40, after initial display in the final rule, are listed in 40 CFR part 9 and appear 

on the information collection instrument as applicable, i.e., form or instructions, and in the 

Federal Register. 

The Agency has established a public docket for this ICR under Docket ID No. EPA-HQOPP-2009-0883, which is available for online viewing at www.regulations.gov, or in person 

viewing at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South 

Building), 2777 S. Crystal Drive, Arlington, VA. This docket facility is open from 8:30 a.m. to 4 

p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 

305-5805. You may submit comments regarding the Agency's need for this information, the 

accuracy of the provided burden estimates and any suggested methods for minimizing 

respondent burden, including the use of automated collection techniques. 

Comments may be submitted to EPA electronically through http://www.regulations.gov

or by mail addressed to OPP Regulatory Public Docket (7502P), Office of Pesticide Programs 

(OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 

20460–0001. You can also send comments to the Office of Information and Regulatory Affairs, 

Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: 

Desk Office for EPA. Include docket ID No. EPA-HQ-OPP-2006-0632 and OMB control 

number 2070-0040 in any correspondence but do not submit EUP applications and any related 

information (e.g., forms, reports, etc.) to these addresses. The information described in this ICR 

is to be submitted to the address identified in section 4(b) of this supporting statement. 

7. ATTACHMENTS to this SUPPORTING STATEMENT

 All of the attachments listed below can be found in the docket for this ICR, identified as 

Docket ID Number, EPA-HQ-OPP-2009-0883, which is accessible electronically through 

www.Regulations.gov. On the main page, select Advanced Search from the menu bar at the 

top and select Docket Search. Enter the Docket ID Number in the Docket ID field. Click on 

the Submit button. From the results page, you will be able to link to the docket view or directly 

open select documents found in the docket. 

Attachment A: Federal Insecticide Fungicide Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. 

http://agriculture.senate.gov/Legislation/Compilations/Fifra/FIFRA.pdf 

Attachment B: EPA Form 8570-17 - Application for an Experimental Use Permit to Ship and 

Use a Pesticide for Experimental Purposes Only 

http://www.epa.gov/opprd001/forms/8570-17.pdf 
September 30, 2010 

Page 18 of 18 

Attachment C: 40 CFR Part 172 - Experimental Use Permits 

(e-CFR: http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&sid=f13a0ae0044f899ce60dffaad0eedc89&rgn=div5&view=text&n

ode=40:23.0.1.1.22&idno=40) 

Attachment D: Renewal Consultations (List of Representatives and Questions Posed)

Attachment E: Consultations Responses

Attachment F: Pesticide Registration (PR) Notice 86-5: Standard Format for Data Submitted 

Under FIFRA and Certain Provisions of FFDCA 

http://www.epa.gov/PR_Notices/pr86-5.html 

Attachment G: Work Sheet used to Calculate Registrant Labor Costs 

Attachment H: Work Sheet used to Calculate EPA Labor Costs