August 26 , 201 3

Page 1 of 18 **SUPPORTING STATEMENT FOR AN INFORMATION COLLECTION REQUEST (ICR)**  **1. IDENTIFICATION OF THE INFORMATION COLLECTION**  **1(a ) Title**  **of the Information Collection** Title : **Experimental U se Permit**  **s (EUP**  **s )**  **for Pesticide**  **s** OMB N o . 2070
- 0040 EPA N o . 0276.1 5 **1(b) Short Characterization/Abstract**  This Information Collection Request (ICR) is a renewal of an existing I CR that is currentl y approved b y OMB and is due to expire June 30, 2014
. 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, Fungicid e, 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 b y EPA. However, FIFRA section 5 authorizes EPA to issue an EUP to allow pesticide companies to temporaril y 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 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 pest icide under Section 3 of FIFRA. This information from the applicant is necessary in order to grant and effectivel y monitor the EUP. The applicant must also provide the Agency with a final report on the results of the experimental program which includes i nformation 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 p esticide materi al, and affected food/f eed 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 #597), which is approved by OMB under OMB Control Number 2070

- 0024. As such, tol erance related activities are not described in this I CR.August 26 , 201 3

Page 2 of 18 **2. NEED FOR AND USE OF THE COLLECTION**  **2(a). Need/Authority for the Collection** As required b y s ection 5 of FIFRA, and Part 172 of Title 40 of the Code of Federal Regulations (40 CFR Part 172), th e 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 temp orary 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 EUP s, it is imperative that the Agency has reports in hand in order to judge the need for such extensions. Exemptions from EUP requireme nts: 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 purp ose 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 on e 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. Bo dies of water involved in or affected b y 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, shellfi sh 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 foo d or feed unless a tolerance or exemption from tolerance exists for the test product.August 26 , 201 3

Page 3 of 18 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 Pe sticides: 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 pesticide s to cause unforeseen adverse impacts. Prior to the initiation of any

small scale field testing involving geneticall y- 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 reque st for an EUP or a renewa l, 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 effect s (as in the case of ph yt otoxicity); 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 subm it 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 pesticid e material produced in conjunction with an EUP would be included in theseAugust 26 , 201 3

Page 4 of 18 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 is publishing a Federal Register (FR) Notice announcing this proposed information collection activity and providing a 60

- day

public comment period. **3(c). Consultations on this Renewal ICR**  In the context of an individual EUP, c onsultation 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 will contact several representatives of pesticide registrants b y e - mail to seek feedback on the EUP information reporting requirements and the regulatory burden estimates e xpressed by the Agency

in this ICR
. EPA will provide a list of those representatives, the questions posed to those representatives, and any responses that are received as part of the final I CR supporting statement. **3 (**  **d) .**  **Effects of Less Frequent Col lection**  There is onl y 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 Ag ency 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 colle ction 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. P esticide 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 ye ars will be exceeded in this program. **3(f). Confidentiality** When trade secret information or Confidential Business In formation (CBI) is provided to the Agency , such information is protected from disclosure under FIFRA Section 10, as amendedAugust 26 , 201 3

Page 5 of 18 and EPA's confidentiality regulation in 40 CFR Part 2, Subpart B. Data submitted to the Agency are handled strictly

in accordance w ith the FIFRA CBI Security Manual. This manual contains instructions relative to all contact with confidential documents, including responsibility of EPA employees; phy sical security measures; CBI materials within EPA, such as CBI typing procedures (docum ents ty ped internall y 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 3253 2 0 (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 appli cation. The ty pe 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 a pplication for an EUP may be submitted by

any company or person wishing to generate the information necessary as required b y section 3 of FIFRA in accordance with the regulations found in 40 CFR 172.2(a). The applicant may be a potential registrant, an in dependent 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 (7 504P) U.S. Environmental Protection Agency 1200 Pennsylvania Ave. NW Washington, D.C. 20460 In formation Required in All EUP Applications :August 26 , 201 3

Page 6 of 18 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 pro posed testing progr am 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, i ncluding 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 qualifi cations of program participants, including those not employed b y 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 o f pro duct b y applicant to determine:
 T oxicity

and effects in or on target organisms;
 T oxicity

and effects in or on non

- target plants, animals and insects at or near the application site; and
 A dverse effects to the environment from application of this pro duct ; and
 H ow the applicant intends to store and dispose of unused pesticide and containers from the proposed experimental use. In formation Required When the Product to be Tested is Not Already Registered : New data required to be submitted for EUP appli cations 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 pes ticides 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 comp lete confidential statement of composition giving the composition of the formulation to be tested as a tabulation of the names and percentage b y weight of each ingredient, both active and inert;August 26 , 201 3

Page 7 of 18  Chemical and ph ys ical properties of each active ingredient of the formulation being tested including the analy tical 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 - e nter 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 Resid ue 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 F FDCA ;

 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 onl y to experimental animals which will be destroyed. Alternativel y, 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 day s, 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 stateme nt “For Experimental Use Only”;  T he 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 pe rmittee, producer, or registrant;  The net contents;  An ingredient statement;  Warning or caution statements;August 26 , 201 3

Page 8 of 18  Any limitations on entry

of persons into treated areas;  The establishment registration number, except in those cases where application of the pesti cide is made solel y by the producer; and  The directions for trial use. Extensions or renewal of EUP s : EUPs and associated temporary tolerances are usually

issued for a period of one or two ye ars. 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 b y a petition for a tolerance, temporary tolerance, an exemption from the requirement of a tolera nce, 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 20 12 , the Pesticide Registration Improvement Act (PRIA) of 20 12 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 decisi on 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 s Program IC R, (OMB Control No. : 2070
- 0179 , EPA I CR No.: 2330 ) , and are not duplicated in this I CR
. Use of an EUP Product on Food or Feed Crops : A product may

onl y 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 indirectl y, 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. Alternativel y, applicants may certify that the food or feed derived from the experimental program will be destro yed or fed onl y to experimental animals for testing purposes, or otherwise disposed of in a mann er 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 test ed 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
.August 26 , 201 3

Page 9 of 18 Section A

- This section should include a data sheet detailing the chemical and phy s ical properties of the test chemical along with a complete statement of the names and percentages b y 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 LD 50 values, eye and skin irritation data for the formulated product, and subacute, teratolo gy (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. S ection D also includes a description of the anal yt ical 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 prod

uct 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 explai ning whether a tolerance exists or is being requested, especiall y if the product is to be tested in a manner that may result in residues in food o r 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 destro yed 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 m easures) 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 an y appropriate prior testing of the product conducted by the applicant to determine, toxicity and effects in or on an y t arget organisms at the site of application; phyt otoxicity andAugust 26 , 201 3

Page 10 of 18 other forms of toxicity

or effects on nontarget plants, animals and i nsects, 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 wit h 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 b y 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 85 70
- 17.August 26 , 201 3

Page 11 of 18 **5. THE INFORMATION COLLECTED** 

**– AGENCY ACTIVITIES, COLLECTION**  **METHODOLOGY, AND INFORMATION MANAGEMENT 5(a). Agency Activities**  The following are activities necessary to evaluate a submitted reques t 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 applicatio n form and the product label are pin

- punched b y date b y the Front

- End Application Processing Unit for initial screening. If every thing is found to be complete, the proposed EUP is given a file sy mbol, entered into the appropriate tracking s ys tem, and a re gistration jacket is created identifying the document by the appropriate Product Manager (PM) for the chemical being employed. The accompan yi ng data is identified and processed for review. The three

- part EUP package is sent to the designated PM who is r esponsible for managing the registration action. The testing program and labeling program are reviewed b y 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 anal ys is of the data. If the data is found to be acceptable, an EUP is issued. I f 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. 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 i nformation 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 o f all submissions

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 maint ain submission information in Agency’s file systemAugust 26 , 201 3

Page 12 of 18 The file is th en updated in the tracking s ys tem 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 wi th 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 adjus ted as appropriate to the specific product under review. As an alternative to submitting a Notification, an applicant may appl y for, and obtain an EUP before conducting a field test with a pesticide. Because the notification requirements have been design ed 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 conducte d onl y 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. Incalculating the respondent burden, EPA will provide burden estimates for those who appl y for chemical pesticide EUP s and for those who appl y for plant

- incorporated protectants (PIPs) EUPs. C onsultations during the previous renewal cycle (EPA No. 0276.1 4) and a revie w of the Agency process for EUP data submissions indicate d the need for the creation of a second response typ e specifically for PIPs because the requirements for field testing of PIPs tend to be more intensive than for chemical pesticides and because of th e time needed to assemble and format the data to fulfill PR N otice 2011
- 3 requirements (Attachment F )
. Based on the number of EUP applications received in fiscal years 20 10 , 20 11 and 20 12 , the estimated annual number of respon ses for chemical pesticides is 8 and the estimated number of EUP applications for PIPs is 2 for each ye ar of the three ye ar renewal cycle. Total respondent burden hours are estimated at 32.8 hours per response for chemical pesticides at a cost of $ 1,970.52 per response, and 147 hours per response for PI Ps at a cost of $ 9,054.07 per response . The total annual respondent burden of the EUP program is estimated to be 556 hours and $ 33,872
. **6(b) Estimating Respondent Costs** Respondent cost is based on the burden as described above and summarized below, and wages, benefits, and overhead for all labor categories for affected industries, state government, and EPA employees. This approach uses a transparent and consistent methodology employingAugust 26 , 201 3

Page 13 of 18 publicly

- available data to provide more accur ate estimates and allow eas y replication of the calculations. Methodology : The methodology uses data on each sector and labor ty pe for an Unloaded wage rate (hourl y wage rate), and calculates the loaded wage rate (unloaded wage rate + benefits), and the f

ully loaded wage rate (loaded wage rate + overhead). Costs are indexed to 2012 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 Employ ment and Wage Estimates from the Bureau of Labor Statistics (BLS) at http://www.bls.gov/oes/current/oes_nat.htm . For l oaded wage rates, benefits represent 44% 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 Attachment s G and H
. Sectors : The specific North American Industry Clas sification Sy stem (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 sy stem 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 c osts, the Agency used the BLS estimates of labor rates for the NAI CS 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, phy sical and social science occupations; and the clerical labor rate is based on the SOC for office and administrative support occupations. The labor rates are full y loaded and indexed to May 2012 dollars ( See Attachment G )
. The full y loaded hourly mean wage rate estimate for managerial occupations is $ 117.73 per hour. For technical occupations, the fully loaded mean wage rate is $ 62.57 per hour, and for occupations the fully loaded mean wage rate is $37. 33 per hour. (See Worksheet for Pesticide Registrants, NAI CS : 3253 0 0 ). Using the Agency ’s burden estimate and the fully

- loaded labor rates, the Agency estimates the applicant labor costs to be approximately $ 1,970.52 per chemical pesticide EUP response, and $9,054.07 per PIPs EUP response. The total labor cost ass ociated with the paperwork burden of the EUP program is estimated to be $33,872 (15,764 + 18,108 )
.August 26 , 201 3

Page 14 of 18 RESPONSE BURDEN AND COST ESTIMATES PER EUP APPLICATION FOR CHEMI CAL PESTICIDES COLLECTION ACTIVITIES BURDEN HOURS (PER YEAR TOTAL

Management $117. 73/hr. Technical

$62.57/hr. Clerical

$37.33/hr. Hours Costs Read regulations 1.3 1.3
- 2.5 $225.38 Plan activities

- 2.5
- 2.5 $156.43 Create information

- 3.0 2.0 5.0 $262.38 Gather information

- 4.3 4.0 8.3 $415.25 Compile and review 2.0 6.0 2.0 10.0 $685.56 Complete paperwork 0.3 0.8 2.0 3.1 $156.91 Store/maintain data

- 0.5 1.0 1.5 $68.62 TOTAL BURDEN 3.6 18.3 11.0 32.8 $1,970.52 AN NUAL BURDEN: 32.8 Hours p er Res ponse x 8 Responses p er Year = 262 Hours ANNUAL COSTS (a) Management: 3.6 hours x $117.73 x 8 respondents $3,344 (b) Technical: 18.3 hours x $62.57 x 8 Respondents $9,135 (c) Clerical: 11.0 hours x $37.33 x 8 respondents $3,285 Total $15,764* * Cost estimates affected by rounding in calculation.
RESPONSE BURDEN AND COST ESTIMATES PER EUP APPLI C ATION FOR PLANT
INCORPORATED PROTECTANTS COLLECTION ACTIVITIES BURDEN HOURS (PER YEAR TOTAL

Management $117.73/hr. Technical

$62.57/hr. Clerical

$37.33/hr. Hours Costs Read regulations 2.0 4.0 0.0 6.0 $485.75 Plan activities 0.0 20.0 0.0 20.0 $1,251,43 Create information 0.0 40.0 4.0 44.0 $2,652,18 Gather information 0.0 6.0 8.0 14.0 $674.07 Compile and re view 4.0 40.0 4.0 48.0 $3,123.11 Complete paperwork 1.0 8.0 4.0 13.0 $767.63 Store/maintain data 0.0 1.0 1.0 2.0 $99.90 TOTAL BURDEN 7.0 119.0 21.0 147.0 $9,054.07 ANNUAL BURDEN: 147.0 Hours p er Response x 2 Responses p er Yea r = 294 Hours ANNUAL COSTS (a) Management: 7.0 hours x $117.73 x 2 Respondents $1,648 (b) Technical: 119.0 hours x $62.57 x 2 Respondents $14,892 (c) Clerical: 21.0 hours x $37.33 x 2 respondents $ 1,568 Total $18,108* * Cost est imates affected by rounding in calculation.August 26 , 201 3

Page 15 of 18 **6(c) Estimating Agency Burden and Costs** For this I CR renewal, the Agency is using data on internal OPP Divisions that provide significant support and analy sis for the EUP ICR program. This data is taken from the Time and Attendance Information Sy stem (TAIS), which archives the Agency ’s Full Time Equivalents (FTEs) for most OPP program activities. The Agency believes that using data from the TAI S reflects the changes to the internal operations for impleme nting 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 new source of data the estimated number of Agency FTE’s dedicated to EUP activities is 0.12 managerial FTE, 1.09 technical FTEs, and 0.07 clerical FTE. Greater detail is given in the below tables. The aggregated Agency estimated FTEs dedicated to EUP activities is 1.28 and, based on 2,080 hours per FTE, the burden hours are 2,654
. **Distribution of Agency Managerial FTEs Supporting EUP**  **Activities** AD BPPD EFED HED RD 0.00 0.05 0.03 0.03 0.01 Agency total 0.12 **Distribution of Agency Technical FTE s Supporting**  **EUP Activities**  AD BPPD EFED HED RD 0.03 0.52 0.27 0.23 0.05 Agency total 1.09 **Distribution of Agency Clerical FTEs Supporting FIFRA EUP**  **Activities** AD BPPD EFED HED RD 0.00 0.03 0.02 0.01 0.00 Agency total 0.07 To determine Agency costs, the Agency used the Bureau of Labor Statistics estimates of labor rates for the North American Industry Classification Sy stem (NAICS) code for the Federal Executive Branch (NAI CS 999100). The managerial labor rate is based on the Standard Occupatio nal Code (SOC) for management occupations; the technical labor rate is based on the SOC for life, phy sical 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 May 20 12 dollars ( See Attachment H )
. The fully loaded hourl y mean wage rate estimate for managerial occupations is $ 120.60 per hour. For technical occupations, the fully loaded mean wage rate is $ 78.24 per hour, and for occ upations the full y loaded mean wage rate is $ 44.61 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 mult iplied 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 ye ars.August 26 , 201 3

Page 16 of 18 ANNUAL BURDEN: 1.28 FTE x 2,080 hours per FTE = 2,654 Hours ANNUAL COSTS (a) Management: 241 hours ( 0.12 FTE) x $120.60 = $ 29,006 (b) Technical: 2,270 hours (1.09 FTE) x $78.24 = $177,617 (c) Clerical: 143 hours (0.07 FTE) x $44.61 = $ 6,377 Total $213,000* * Cost estimates affected by rounding in calculation **6(d) Bottom Line Hour s and Costs / Master Table**  MASTER TABLE TOTAL

Hours Costs Respondent Burden/Cost Estimates: 556 $33,872 Agency Burden/Cost Estimates: 2,654 $213,000 **6(e) Reasons For Changes in Burden** Annual respondent burden i s estimated in this renewal to be 556 hours. This is a decrease from the estimate in the previous ICR of 1,351 hours (1907

– 556 =1,351). This decrease is an adjustment as a result of reduced experimental use permit (EUP) submissions by program participants, as well as a decrease in the portion of EUP applications that are for plant

incorporated protectants (PIPs). Estimated respondent costs have also decreased from $114,566 to $33,872. Estimated Agency

burden and total costs has also been adjusted downwards from 4,271 hours to 2,654 hours and from $325,325 to $213,000

. This is a result of a decrease in the number of responses used to calculate Agency burden. **6(f) Burden Statement** The total annual “respondent” (applicant) burden for the r enewal IC R entitled Experimental Use Permit (EUP) for Pesticides is estimated to be 556 hours with an average potential per respon se burden of between 32.8 hours for chemical pesticides and 147 hours for plant

- incorporated protectants. “B urden” is defined in 5 CFR 1 320.3(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 currentl y 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 I CR under Docket ID No. EPA
- HQ
OPP
- 2013
- 0617 , which is available for online viewing at www.regulations.gov , or in person viewing at the OPP Docket in the EPA Docket Center, EPA West, Rm. 3334, 1200 Pennsylvania Ave, NW, Washingt on, DC 20460
- 0001. This docket facility is open from 8:30 a.m. to 4 :30 p.m., Monday

through Friday , excluding legal holiday s. The docket telephone number is (703) 305
- 5805.August 26 , 201 3

Page 17 of 18 You may submit comments regarding the Agency's need for this information, the a ccuracy 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 b y mail address ed 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
- 2013
- 0617 and OMB control number 2070

- 0040 in any correspondence , but do not submit EUP applications and an y related info rmation (e.g., forms, reports, etc.) to these addresses. The information described in this I CR is to be submitted to the address identified in section 4(b) of this supporting statement.August 26 , 201 3

Page 18 of 18 **7 .**  **ATTACHMENTS to this SUPPORTING STATEMENT** All of the attachment s listed below can be found in the docket for this ICR , identified as Docket ID Number, **EP A**  **- HQ**  **- OPP**  **- 2013**  **- 0617**  , which is accessible electronically through **www.regulations.gov**
. On the main page, select **Advanced Sear ch**  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 do cket. **Attachment A** : Federal Insecticide Fungicide Rodenticide Act (FIFRA) , 7 U.S.C. 136 et seq .

http://www.epa.gov/opprd001/registrationmanual/FIFRA.pdf **Attachment B:** EPA Form 8570
- 17
- Application f or an Experimental Use Permit t o Ship and Use a Pesticide f

or Experimental Purposes Only http://www.epa.gov/opprd001/forms/8570

- 17.pdf **Attachment C :**  40 CFR Part 172
- Experimental Use Permits

(e

- CFR : http://www.ecfr.gov/cgi

- bin/text

idx?c=ecfr&SID=7fd873207444a629c7cb2c2079717f48&rgn =div5&view=text &node=40:25.0.1.1.21&idno=40 ) **Attachment D**  **:** PLACEHOLDER
- Renewal Consultations (L ist of Representatives and

Questions Posed) **Attachment E**  **:** PLACEHOLDER
- Consultations Responses **Attachment F**  **:** Pesticide Registration (PR) Notice 2011
- 3 : S tandard 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 G**  **:** Work Sheet used to Calculate Registrant Labor Costs **Attachment H**  **:** Work Sheet used to Calculate EPA Labor Costs