**FINAL JUSTIFICATION STATEMENT FOR**

**AN INFORMATION COLLECTION REQUEST (ICR)**

**1. [Identification of the Information Collection]{.underline}**

> **1(a) Title of the Information Collection**
>
> Title: Application for Experimental Use Permit (EUP) to Ship and Use a
> Pesticide for Experimental Purposes Only
>
> OMB NO.: 2070-0040 EPA NO.: 0276.13
>
> **1(b) Short Characterization/Abstract**

This information collection provides the EPA with the data necessary to
determine whether to issue an experimental use permit under section 5 of
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as
amended. FIFRA requires that before a pesticide product may be
distributed or sold in the U.S. it must be registered by EPA. However,
section 5 authorizes EPA to issue experimental use permits which 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,
EUP\'s are issued either for a pesticide not registered with the Agency
or for a registered pesticide for a use not registered with the Agency.

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.

EPA Form 8570-17, [Application for An Experimental Use Permit to Ship
and Use a Pesticide for Experimental Purposes Only]{.underline}, is
filed by the prospective registrant for a permit to generate information
or data necessary to register a pesticide under Section 3 of FIFRA, (see
Final Attachment A). 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 experimental use
permitted are to be shipped in commerce, the applicant must also submit
a petition for temporary tolerance pursuant to the Federal Food, Drug,
and Cosmetic Act (FFDCA). This program is more fully described in ICR
No. 2070‑0024 "Tolerance Petitions for Pesticides and Inert Ingredients
on Food/Feed," EPA No. 0597.

**2. [Need for and Use of the Collection]{.underline}**

**2(a) Need/Authority for the Collection**

As required by section 5 of FIFRA, (see Final Attachment B), 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. 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 which would require issuance of a
temporary tolerance or 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 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 EUP's 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 microbials 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 172.43‑59. 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 renewal, extension or amendment of the EUP, if
    requested, is justified;

-   Adequately monitor 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

-   Review efficacy data which may contain important health data.

**3. [Non duplication, Consultations, and Other Collection
Criteria]{.underline}**

**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 (Final Attachment C), however, does require annual pesticide
production reports from all persons who produce pesticides. 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**

Pursuant to 5 CFR 1320.8(d), EPA published a Federal Register (FR)
notice (71 FR 62436; October 25, 2006) soliciting comment on this
information collection activity and the Agency's intent to renew the OMB
approval of this ICR. No public comments were received.

**3(c) Consultations**

Consultation and/or dialogue between the respondent and EPA occurs on an
informal, ongoing \"as needed\" basis, primarily during the submission
and review of the application for an experimental use permit.
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.

During the preparation of this ICR renewal, EPA staff contacted several
representatives of pesticide registrants by e-mail to seek feedback on
the EUP information reporting requirements and process. A copy of the
ICR questionnaire is provided in Final Attachment D. The Agency received
no comments from the representatives listed below during the
consultation period.

+-----------------------------------+-----------------------------------+
| Russell Schneider                 | Greg Watson                       |
|                                   |                                   |
| Monsanto                          | Syngenta                          |
|                                   |                                   |
| <                                 | <greg.watson@syngenta.com>        |
| russell.p.schneider@monsanto.com> |                                   |
+-----------------------------------+-----------------------------------+
| Don Carlson                       | Jim Barron                        |
|                                   |                                   |
| FMC Corporation                   | Bayer                             |
|                                   |                                   |
| <don_carlson@fmc.com>             | <jim.barron@bayercropscience.com> |
+-----------------------------------+-----------------------------------+

**3(d) Effects of Less Frequent Collection**

There is only one submission required in conjunction with each request
for EPA approval to conduct testing on certain pesticides. Therefore,
the frequency of the collection cannot be reduced, except to eliminate
the collection altogether. The Agency then would have no means by which
to evaluate the potential human health risks and environmental hazard
presented by a proposed test.

**3(e) General Guidelines**

The only guideline under the Paperwork Reduction Act (PRA) that is
exceeded in this collection is the time period for retaining records.
EPA requirements in 40 CFR 169.2(k) state that records containing
research data relating to registered pesticides be retained as long as
the registration is valid and the manufacturer remains in business.
Pesticide registrations are valid until they are either voluntarily
canceled or withdrawn by the registrant or until EPA has cause to
suspend or cancel the registration. Since the average period of
marketability of a pesticide ranges from 15 to 30 years, the PRA
guidelines specifying that data other than health, medical, or tax
records not be required to be retained for more than three years will be
exceeded in this program.

**3(f) Confidentiality and Sensitive Questions**

> **3(f)(i) 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, Title 40 CFR, 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 Prevention, Pesticides and
Toxic Substances paper shredder.

> **3(f)(ii) 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]{.underline}**

**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. 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;

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-   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 nontarget 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*

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
    Federal Food, Drug and Cosmetic Act;

-   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 Federal Food, Drug and Cosmetic Act (FFDCA); 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 experimental use permit 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 Experimental Use Permits*

EUPs and associated temporary tolerances are usually issued for a period
of one or two years. The permit and any associated temporary tolerances,
may be extended, renewed, or amended upon written request to the Agency,
if circumstances warrant.

*Fee Requirements*

EUP applications that include a petition for a tolerance, temporary
tolerance, an exemption from the requirement of a tolerance, or a
temporary tolerance exemption are generally subject to the fee
requirements established by the Pesticide Registration Improvement Act
(PRIA) of 2003. An extension or renewal request for a temporary
tolerance is also generally subject to a fee requirement. However, PRIA
also established that certain entities may be eligible for a waiver or
reduction of these fees, including small businesses (as defined under
PRIA) and IR-4 applicants. The paperwork burdens associated with
requesting a waiver or reduction of these fees are estimated in the
Pesticide Registration Fee Waivers ICR (OMB Control No. 2070-0167, EPA
ICR No. 2147).

*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 Federal Food Drug and Cosmetic Act (FFDCA).

If a tolerance, exemption from the requirement of a tolerance has not
been issued for such residues, applicants must include with the
application a petition for establishment of appropriate tolerances,
exemptions from the requirement of a tolerance, or food additive
regulation in accordance with 40 CFR 180. Alternatively, applicants may
certify that the food or feed derived from the experimental program will
be destroyed or fed only to experimental animals for testing purposes,
or otherwise disposed of in a manner which will not endanger man or the
environment.

*Suggested Format for an Experimental Use Permit 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]{.underline}

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]{.underline}

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]{.underline}

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]{.underline}

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]{.underline}

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]{.underline}

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]{.underline}

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
Experimental Use Permit*

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 become familiar with the legislation and regulations
  5 and 40 CFR       and determine the requirements as they pertain to a
  172.8(b)           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,  check information for accuracy and completeness
  and review         
  information        

  complete paperwork prepare notification document or containment record

  record, disclose,  submit notification to OPP
  and display        
  information        

  store, maintain,   retain copies of all submissions
  and file           
  information        
  ------------------ ----------------------------------------------------

**5. [The Information Collected--Agency Activities, Collection
Methodology, and Information Management]{.underline}**

**5(a) Agency Activities**

The following are activities necessary to evaluate a submitted request
for an experimental use permit:

  ------------------ ----------------------------------------------------
  **Activity**       **Explanation**

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

  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.
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. 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]{.underline}**

**6(a) Estimating the Respondent Burden**

Respondent burden hours are estimated at 10.10 hours per respondent with
a cost of \$644.37 per response. Based on the approximate number of
applications received in fiscal years 2003, 2004 and 2005, the
anticipated number of respondents for each of the next three fiscal
years is 75. The total respondent burden is estimated to be 757.5 hours.

**6(b) Estimating Respondent Costs**

For a period of some years when estimating labor rates for most OPP
program ICR renewals, the Agency adjusted the ICR renewal labor rates by
using the NASA Gross Domestic Product (GDP) Deflator Inflation
Calculator to index the labor cost for a particular year. However, in
July 2006, Agency economists completely re-estimated wages, benefits,
and overhead for all labor categories for the pesticide industry, state
government and Agency employees. The Agency analysis uses currently
available information on labor rates and other benefits from publicly
available websites. A copy of the methodology used to re-estimate the
labor rates and formulas used to derive the fully loaded rates and
overhead costs are listed in Final Attachment E.

To derive the labor rates for this ICR, Agency economists estimated the
wages for the management, technical, and clerical labor categories using
the methodology cited above. The respondent costs for this renewal for
managerial, technical and clerical rates are estimated at \$100.86,
\$64.80, and \$33.05 per hour, respectively. These labor rates are fully
loaded and include benefits and overhead costs. Using the Agency's
burden estimate and the fully-loaded labor rates, the Agency estimates
the applicant labor costs to be approximately \$644.35 per response.
This total labor cost associated with the paperwork burden is estimated
to be **\$48,327.45**

ANNUAL RESPONDENT BURDEN/COST ESTIMATES

+------------------+-----------+----------+--------+-------+--------+
| COLLECTION       | Burden    |          |        | TOTAL |        |
| ACTIVITIES       | Hours     |          |        |       |        |
|                  | (per      |          |        |       |        |
|                  | year)     |          |        |       |        |
+------------------+-----------+----------+--------+-------+--------+
|                  | Mgmt.     | Tech.    | Cler.  | Hours | Costs  |
|                  |           |          | \$33.  |       |        |
|                  | \$1       | \$6      | 05/hr. |       |        |
|                  | 00.86/hr. | 4.80/hr. |        |       |        |
+------------------+-----------+----------+--------+-------+--------+
| Read regulations | 0.5       | 0.5      | 0.0    | 1.0   | \      |
|                  |           |          |        |       | $82.83 |
+------------------+-----------+----------+--------+-------+--------+
| Plan activities  | 0.0       | 1.0      | 0.0    | 1.0   | \      |
|                  |           |          |        |       | $64.80 |
+------------------+-----------+----------+--------+-------+--------+
| Create           | 0.0       | 2.0      | 0.0    | 2.0   | \$     |
| information      |           |          |        |       | 129.60 |
+------------------+-----------+----------+--------+-------+--------+
| Gather           | 0.0       | 2.5      | 0.0    | 2.5   | \$     |
| information      |           |          |        |       | 162.00 |
+------------------+-----------+----------+--------+-------+--------+
| Compile and      | 0.0       | 2.0      | 0.0    | 2.0   | \$     |
| review           |           |          |        |       | 129.60 |
+------------------+-----------+----------+--------+-------+--------+
| Complete         | 0.1       | 0.5      | 0.0    | 0.6   | \      |
| paperwork        |           |          |        |       | $42.49 |
+------------------+-----------+----------+--------+-------+--------+
| Store/maintain   | 0.0       | 0.0      | 1.0    | 1.0   | \      |
| data             |           |          |        |       | $33.05 |
+------------------+-----------+----------+--------+-------+--------+
| TOTAL            | 0.6       | 8.5      | 1.0    | 10.1  | \$     |
|                  |           |          |        |       | 644.37 |
+------------------+-----------+----------+--------+-------+--------+

ANNUAL BURDEN: 10.10 Total Hours x 75 Respondents = 757.50 Hours

ANNUAL COSTS

\(a\) Management: 0.6 hours x \$100.86 x 75 Respondents \$4,538.70

\(b\) Technical: 8.50 hours x \$64.80 x 75 Respondents \$41,310.00

\(c\) Clerical: 1.00 hours x \$33.05 x 75 respondents
[\$2,478.75]{.underline}

**Total \$48,327.45**

> **6(c) Estimating Agency Burden and Costs**

The Agency needs to process, review and document their evaluation of EUP
applications. Each year, the Agency may spend 1,125 burden hours to
process the 75 applications EUP applications the Agency receives.
Estimates for the Agency\'s burden and the associated costs are provided
below.

ANNUAL AGENCY BURDEN/COST ESTIMATES

+--------------------+----------+---------+--------+------+---------+
| COLLECTION         | Burden   |         |        | T    |         |
| ACTIVITIES         | Hours    |         |        | OTAL |         |
|                    | (per     |         |        |      |         |
|                    | year)    |         |        |      |         |
+--------------------+----------+---------+--------+------+---------+
|                    | Mgmt.    | Tech.   | Cler.  | H    | Costs   |
|                    |          |         |        | ours |         |
|                    | \$9      | \$6     | \$47   |      |         |
|                    | 3.07/hr. | 6.34/hr | .17/hr |      |         |
+--------------------+----------+---------+--------+------+---------+
| Review submitted   | 0.0      | 2.0     | 0.0    | 2.0  | \       |
|                    |          |         |        |      | $132.68 |
| application        |          |         |        |      |         |
| package            |          |         |        |      |         |
+--------------------+----------+---------+--------+------+---------+
| Record submission  | 0.0      | 1.0     | 0.0    | 1.0  | \$66.34 |
+--------------------+----------+---------+--------+------+---------+
| Analyze submission | 1.0      | 8.0     | 0.0    | 9.0  | \       |
|                    |          |         |        |      | $623.79 |
+--------------------+----------+---------+--------+------+---------+
| File submission    | 0.0      | 2.0     | 1.0    | 3.0  | \       |
|                    |          |         |        |      | $179.85 |
+--------------------+----------+---------+--------+------+---------+
| TOTAL              | 1.0      | 13.0    | 1.0    | 15.0 | \$      |
|                    |          |         |        |      | 1002.66 |
+--------------------+----------+---------+--------+------+---------+

ANNUAL BURDEN: 15 Total Hours x 75 Applicants = 1,125 Hours

ANNUAL COSTS

\(a\) Management: 1.0 hours x \$93.07 x 75 applicants \$6980.25

\(b\) Technical: 13.0 hours x \$66.34 x 75 applicants \$64,681.50

\(c\) Clerical: 1.0 hours x \$47.17 x 75 applicants
[\$3,537.75]{.underline}

**Total \$75,199.50**

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

MASTER TABLE

  ------------------------------- ------------------- --------------------
                                  TOTAL               

                                  Hours               Costs

  Respondent Burden/Cost          757.50              \$48,327.45
  Estimates:                                          

  Agency Burden/Cost Estimates:   1,125               \$75,199.50
  ------------------------------- ------------------- --------------------

**6(e) Reasons For Changes in Burden**

There is no change to the Agency's burden estimate.

**6(f) Burden Statement**

The total annual "respondent" (applicant) burden for the proposed
renewal ICR entitled Application For Experimental Use Permit (EUP) To
Ship And Use A Pesticide For Experimental Purposes Only, is estimated to
be 757 with an average potential per respondent burden of 10 hours.
According to the Paperwork Reduction Act, "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. For this collection, it is the time reading the regulations,
planning the necessary data collection activities, conducting tests,
analyzing data, generating reports and completing other required
paperwork, and storing, filing, and maintaining the data. 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. The OMB control number for this information collection
appears at the beginning and the end of this document. In addition OMB
control numbers for EPA's regulations, 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.

The Agency has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2006-0632, which is available for online viewing at
[www.regulations.gov](http://www.regulations.gov/), or in person viewing
at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard
(South Building), 2777 S. Crystal Drive, Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-5805.
You may submit comments regarding the Agency\'s need for this
information, the accuracy of the provided burden estimates and any
suggested methods for minimizing respondent burden, including the use of
automated collection techniques.

Comments may be submitted to EPA electronically through
[http://www.regulations.gov]{.underline} or by mail addressed to
Director, Collection Strategies Division, U.S. Environmental Protection
Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. You
can also send comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, NW,
Washington, DC 20503, Attention: Desk Office for EPA. Include docket ID
No. EPA-HQ-OPP-2006-0632 and OMB control number 2070-0040 in any
correspondence but do not submit Experimental Use Permit applications
and any related information (e.g., forms, reports, etc.) to these
addresses. The information described in this ICR is to be submitted to
the address identified in section 4(b) of this supporting statement.

ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachments to the supporting statement are available in the public
docket established for this ICR under docket identification number
EPA-HQ-OPP-2006-0632. These attachments are available for online viewing
at [[www.regulations.gov]{.underline}](http://www.regulations.gov_/) or
otherwise accessed as described in section 6(f) of the supporting
statement.

Final Attachment A - EPA Form 8570-17 - [Application For An Experimental
Use Permit To Ship And Use A Pesticide For Experimental Purposes
Only]{.underline} - available electronically at
<http://www.epa.gov/opprd001/forms/>.

Final Attachment B - FIFRA Section 5 - available electronically at

<http://www.epa.gov/epahome/laws.htm>[.]{.underline}

Final Attachment C - FIFRA Section 7 - available electronically at

<http://www.epa.gov/epahome/laws.htm>[.]{.underline}

Final Attachment D -- Sample Consultation Questionnaire

Final Attachment E -- Methodology for Estimating OPP ICR Wage Rates for
Industry, State and EPA Labor Costs; Memo From Richard Keigwin, Director
Biological and Economic Analysis Division, to OPP Division Directors,
July 2006

Final Attachment F - Display Related to OMB Control #2070-0040 -
Listings of Related Regulations in 40 CFR 9.1