0276ss16

July 21, 2018

SUPPORTING STATEMENT FOR

AN INFORMATION COLLECTION REQUEST (ICR)

1. IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) Title:

Title: Experimental Use Permits (EUPs) for Pesticides

OMB No. 2070-0040 EPA No. 0276.16

Docket Id No. EPA-HQ-OPP-2017-0628

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 August 31, 2018. 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 pesticide.

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 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) unless a tolerance is already established. The information collection activities associated with tolerances are addressed in a separate ICR (EPA ICR #0597), which is approved by OMB under OMB Control Number 2070-0024. As such, tolerance related activities are not described in this ICR.

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 the existence of a tolerance or the issuance of a temporary tolerance. If there is no tolerance, the crop must be destroyed 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.

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;

• 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 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

EPA published a notice in the Federal Register announcing a 60-day public notice and comment period on the draft ICR on December 11, 2017 (82 FR 58195). EPA received no public comments in response to this notice, which is available in the docket for this ICR and can be accessed at http://www.regulations.gov using the docket identifier EPA-HQ-OPP-2017-0628.

3(c). Consultations on this Renewal ICR

In the context of an individual EUP, consultation and/or dialogue between the respondent and renewal of this ICR, as required under 5 CFR 1320.8(d)(1) the Agency consulted with stakeholders who actively interact with the Agency through the use of this collection instrument. The consultation respondents who replied to EPA’s consultation request generally agreed that the burden estimates in the ICR were reasonable, and did not have specific suggestions for improving or clarifying the current collection. Therefore, the Agency made no changes to the ICR based on the consultations. A record of the consultations (Attachment D) is available in the public docket online at http://www.regulations.gov, referencing Docket ID No. EPA-HQ-OPP-2017-0628.

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.

Electronic Submissions:

In accordance with 5 CFR 1320.5(a)(1)(iii)(E), federal agencies are required to indicate whether the proposed collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and an explanation of the decision. In September 2015, OPP debuted a new electronic system for pesticide applications, the Pesticide Submission Portal (PSP). The electronic submission process is a combination of document file uploads and providing information online that is equivalent to existing OMB approved forms that would otherwise be filled out, printed, and mailed to EPA. The paperwork burdens associated with the submissions of pesticide registration applications through the PSP are covered under the “Application for New and Amended Pesticide Registration” ICR, OMB No 2070-0060. Additionally, the current PSP leverages the Agency’s existing Central Data Exchange (CDX) to provide a secure method of submitting these documents and information within a secure online environment. CDX does require initial user registration for which the paperwork burden estimate is covered under “Cross-Media Electronic Reporting Rule” ICR, OMB No. 2025-0003.

Pesticide companies seeking an experimental use permit can now submit their applications through the PSP. This includes forms, studies, and draft product labeling. Applicants need not submit multiple electronic copies of any pieces of their applications. In PR Notice 2011-3 (Attachment E), EPA made clear that the requirement to submit multiple copies of data is applicable only to paper submissions. Similarly, EPA interprets the requirement to submit five copies of draft labeling in 40 CFR 152.50(e) to apply only to applications made on paper. As electronic submissions are easily reproducible, EPA will accept electronic applications containing one electronic copy of all the required elements.

While electronic submissions are now being accepted, EPA continues to accept paper applications but encourages applicants to take advantage of this new, more efficient option and forego the courier costs to send to EPA. Additional benefits of using the Portal include a status indicator that allows registrants to track the movement of their submissions and automatically generated MRID numbers. Guidance for electronic submission through the PSP is available to applicants at https://www.epa.gov/pesticide-registration/electronic-submissions-pesticide-applications.

While EPA has begun to see some EUP applications being submitted to the Agency through the PSP, it is too early to quantify any change in burden associated with electronic submissions. The Agency's pesticide program, along with the pesticide industry, recognizes that there are advantages in terms of accuracy, speed, cost and personnel from electronic data transfer technologies. In addition, OPP continues to consult with industry associations and other federal agencies and is participating in an Agency-wide workgroup to develop electronic reporting standards intended to facilitate the submission and use of information about pesticides. The Agency intends to reach out to some of those companies who have submitted electronic EUP applications during the consultation process.

Other information submission methods:

With paper submissions, ordinarily, registrants would be required to submit three paper copies of study data to EPA, or two paper copies if they submit the required study data in Adobe Acrobat Portable Document Format (PDF) on a compact disc.

Other alternatives to paper-based records and data submissions include the use of “web forms”/XML based submissions via the Agency’s Internet site, magnetic media-based submissions (e.g., diskette, CD-ROM, etc.), and now through EPA’s new Pesticide Submissions Portal (PSP).

There are two non-CDX based methods by which companies can assemble the electronic-Submission (or "e-Submissions”) discs for e-Submissions. In both methods, the files to be submitted along with an XML data file containing information about the files and the submission itself are “zipped” into a single file and placed on a disc (CD/DVD) for submission to the EPA. The first is a newer method introducing the use of a “builder” application. The second, introduced in July 2008, requires the manual editing of the XML file. The XML method of information exchange from industry to EPA is based on a harmonized XML schema used by Canada's Pest Management Regulatory Agency (PMRA), which OPP has adapted. This harmonization assures industry that a documentation package submitted to one participating regulatory agency can also be submitted to the other participating agency, increasing standardization and decreasing the burden on industry. Additional information about both e-submission methods can be accessed at: https://www.epa.gov/pesticide-registration/assembly-electronic-packages-and-discs.

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 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 325320 (Pesticide and other Agricultural Chemical Manufacturing).

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. Paper 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:

• 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

• 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.

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 October 2012, the Pesticide Registration Improvement Act (PRIA) of 2012 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 Fees Program ICR, (OMB Control No.: 2070-0179, EPA ICR No.: 2330), 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, or 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 humans 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.

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;

• 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

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:

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

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. These applications may be submitted either through the PSP, “web forms”/XML based submissions via the Agency’s Internet site, magnetic media-based submissions (e.g., diskette, CD-ROM, etc.) or by paper.

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 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

The burden associated with this collection of information is described in detail in the following sections. In calculating the respondent burden, EPA will provide burden estimates for those who apply for chemical pesticide EUPs and for those who apply for plant-incorporated protectants (PIPs) EUPs.

Based on the number of EUP applications received in fiscal years 2014, 2015, and 2016, the estimated annual average number of responses for chemical pesticides is 8.3 and the estimated average number of EUP applications for PIPs is 2.0 for each year of the three-year renewal. For this renewal, the Agency continues to assume that EUP applications will be submitted via paper since it is too early to quantify any change in burden as a result of the new electronic submission options. However, EPA notes that some EUP applications have been submitted through the PSP in the past year, and the Agency anticipates that the number of applications submitted electronically will grow as applicants become more familiar with the electronic submission options. EPA plans on reevaluating these burdens if it receives new information during the consultation period and public comment period for this ICR. Given the assumption that applications are submitted via paper, the total respondent burden hours are estimated at 32.8 hours per response for chemical pesticides at a cost of $2,150.51 per response, and 147 hours per response for PIPs at a cost of $9,788.22 per response. The total annual respondent burden of the EUP program is estimated to be 567 hours and $37,497.

6(b) Estimating Respondent Costs

Respondent cost is based on the burden as described above and summarized below. This includes the fully loaded wage rates (wages, benefits, and overhead) for all labor categories for affected industries, state government, and EPA employees. This approach uses a transparent and consistent methodology employing publicly-available data to provide more accurate estimates and allow easy replication of the calculations.

Methodology: The methodology uses data on each sector and labor type for an Unloaded wage rate (hourly wage rate), and calculates the loaded wage rate (unloaded wage rate + benefits), and the fully loaded wage rate (loaded wage rate + overhead). Costs are indexed to 2016 dollars.

Wage Rates: Wages are estimated for occupations (management, technical, and clerical) within applicable sectors. The Agency uses average unloaded wage data for the relevant sectors available in the National Industry-Specific Occupational Employment and Wage Estimates from the Bureau of Labor Statistics (BLS) at http://www.bls.gov/oes/current/oes_nat.htm. For loaded wage rates, benefits represent 46.4% of unloaded wage rates, based on benefits for all civilian non-farm workers, from http://www.bls.gov/oes/current/oes_nat.htm. Fully loaded wage rates include an additional 50% on top of the loaded wage rate to capture overhead costs (EPA guidelines 20-70%). The data and calculations for wage rates used in this document are presented in Attachments F and G.

Sectors: The specific North American Industry Classification System (NAICS) code and website for each sector is included in that sector’s wage rate table. Within each sector, the wage data are provided by Standard Occupational Classification (SOC). The SOC system is used by Federal statistical agencies to classify workers into occupational categories for the purpose of collecting, calculating, or disseminating data (see http://www.bls.gov/oes/current/oes_stru.htm ).

To determine respondent costs, the Agency used the BLS estimates of labor rates for the NAICS code for Pesticide Registrants (NAICS 325300). The managerial labor rate is based on the 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 March 2016 dollars (See Attachment F). The fully loaded hourly mean wage rate estimate for managerial occupations is $124.81 per hour. For technical occupations, the fully loaded mean wage rate is $67.19 per hour, and for occupations the fully loaded mean wage rate is $43.74 per hour (Attachment F).

Using the Agency’s burden estimate and the fully-loaded labor rates, the Agency estimates the applicant labor costs to be approximately $2,150.51 per chemical pesticide EUP response, and $9,788.22 per PIPs EUP response. The total labor cost associated with the paperwork burden of the EUP program is estimated to be $37,497 (17,921 + 19,576).

RESPONSE BURDEN AND COST ESTIMATES PER EUP APPLICATION FOR CHEMICAL PESTICIDES

COLLECTION ACTIVITIES	BURDEN HOURS (PER YEAR			TOTAL
	Management $124.81/hr.	Technical $67.19/hr.	Clerical $43.74/hr.	Hours	Costs
Read regulations	1.3	1.3	-	2.5	$240.01
Plan activities	-	2.5	-	2.5	$167.98
Create information	-	3.0	2.0	5.0	$289.06
Gather information	-	4.3	4.0	8.3	$460.54
Compile and review	2.0	6.0	2.0	10.0	$740.27
Complete paperwork	0.3	0.8	2.0	3.1	$175.32
Store/maintain data	-	0.5	1.0	1.5	$77.34
TOTAL BURDEN	3.6	18.3	11.0	32.8	$2,150.51

ANNUAL BURDEN: 32.8 Hours per Response x 8.3 Responses per Year = 273 Hours

ANNUAL COSTS

(a) Management: 3.6 hours x $124.81 x 8.3 respondents $3,692

(b) Technical: 18.3 hours x $67.19 x 8.3 Respondents $10,219

(c) Clerical: 11.0 hours x $43.74 x 8.3 respondents $4,010

Total $17,921*

*Cost estimates affected by rounding in calculation.

RESPONSE BURDEN AND COST ESTIMATES PER EUP APPLICATION FOR PLANT-INCORPORATED PROTECTANTS

COLLECTION ACTIVITIES	BURDEN HOURS (PER YEAR)			TOTAL
	Management $124.81/hr.	Technical $67.19/hr.	Clerical $43.74/hr.	Hours	Costs
Read regulations	2.0	4.0	0.0	6.0	$518.40
Plan activities	0.0	20.0	0.0	20.0	$1,343.86
Create information	0.0	40.0	4.0	44.0	$2,862.69
Gather information	0.0	6.0	8.0	14.0	$753.09
Compile and review	4.0	40.0	4.0	48.0	$3,361.94
Complete paperwork	1.0	8.0	4.0	13.0	$837.32
Store/maintain data	0.0	1.0	1.0	2.0	$110.93
TOTAL BURDEN	7.0	119.0	21.0	147.0	$9,788.22

ANNUAL BURDEN: 147.0 Hours per Response x 2.0 Responses per Year = 294 Hours

ANNUAL COSTS

(a) Management: 7.0 hours x $124.81 x 2.0 Respondents $1,747

(b) Technical: 119.0 hours x $67.19 x 2.0 Respondents $15,992

(c) Clerical: 21.0 hours x $43.74 x 2.0 respondents $ 1,837

Total $19,576*

*Cost estimates affected by rounding in calculation.

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 2012 (PRIA) as reauthorized.

Using this source of data, the estimated number of Agency FTE’s dedicated to EUP activities is 0.10 managerial FTE, 0.78 technical FTEs, and 0.04 clerical FTE. Greater detail is given in the below tables. The aggregated Agency estimated FTEs dedicated to EUP activities is 0.92 and, based on 2,080 hours per FTE, the burden hours are 1,922.

Distribution of Agency Managerial FTEs Supporting EUP Activities

AD	BPPD	EFED	HED	RD
0.00	0.06	0.01	0.00	0.02
Agency total					0.10

Distribution of Agency Technical FTEs Supporting EUP Activities

AD	BPPD	EFED	HED	RD
0.02	0.52	0.07	0.00	0.17
Agency total					0.78

Distribution of Agency Clerical FTEs Supporting FIFRA EUP Activities

AD	BPPD	EFED	HED	RD
0.00	0.02	0.00	0.00	0.01
Agency total					0.04

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 March 2016 dollars (Attachment G). The fully loaded hourly mean wage rate estimate for managerial occupations is $127.07 per hour. For technical occupations, the fully loaded mean wage rate is $83.40 per hour, and for clerical occupations the fully loaded mean wage rate is $47.14 per hour (Attachment G).

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: 0.93 FTE x 2,080 hours per FTE = 1,922 Hours

ANNUAL COSTS

(a) Management: 215 hours (0.10 FTE) x $127.07 = $ 27,364

(b) Technical: 1,631 hours (0.78 FTE) x $83.40 = $135,993

(c) Clerical: 76 hours (0.04 FTE) x $47.14 = $ 3,563

Total $166,920*

*Cost estimates affected by rounding in calculation

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

MASTER TABLE

	TOTAL
	Hours	Costs
Respondent Burden/Cost Estimates:	567	$37,497
Agency Burden/Cost Estimates:	1,922	$166,920

6(e) Reasons For Changes in Burden

Annual respondent burden is estimated in this renewal to be 567 hours. This is a slight increase from the estimate in the previous ICR of 556 hours. This increase is an adjustment as a result of increased EUP submissions by program participants, as well as higher wage rates for managerial, technical, and clerical occupations. Estimated respondent costs have also increased from $33,872 to $37,497.

Estimated Agency burden and total costs has been adjusted downwards from 2,654 hours to 1,922 hours and from $213,000 to $166,920. This is a result of a decrease in the number of responses used in calculating Agency burden.

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 567 hours with an average potential per response burden of between 32.8 hours for chemical pesticides and 147 hours for plant-incorporated 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.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An 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. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

To comment on 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, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OPP-2017-0628, which is available for online viewing at www.regulations.gov, or in person viewing at the OPP Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, NW, Washington, D.C. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744.

An electronic version of the public docket is available at www.regulations.gov. This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select “search,” then key in the Docket ID Number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA, and via email to oira_submission@omb.eop.gov. Please include the EPA Docket ID Number EPA-HQ-OPP-2017-0628 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.

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-2017-0628, which is accessible electronically through http://www.regulations.gov. Direct links are provided for those documents that are also available online elsewhere.

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

https://www.epa.gov/sites/production/files/documents/fifra.pdf

Attachment B: EPA Form 8570-17 - Application for Experimental Use Permit to Ship and Use a Pesticide for Experimental Purposes Only

https://www.epa.gov/sites/production/files/2013-07/documents/8570-17.pdf

Attachment C: 40 CFR Part 172 - Experimental Use Permits

e-CFR: https://ecfr.io/Title-40/pt40.26.172

Attachment D: Record of Consultations for OPP ICR: “Experimental Use Permits (EUPs) for Pesticides”

Attachment E: Pesticide Registration (PR) Notice 2011-3: 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)

http://www.epa.gov/pesticides/PR_Notices/pr2011-3.pdf

Attachment F: Work Sheet used to Calculate Registrant Labor Costs

Attachment G: Work Sheet used to Calculate EPA Labor Costs

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