Document ID: EPA-HQ-OPP-2006-0632-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-10-31T05:00Z

JUSTIFICATION STATEMENT FOR 

AN INFORMATION COLLECTION REQUEST (ICR)

1.	Identification of the Information Collection

1(a)	Title of the Information Collection:  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 Request (ICR) is a proposed renewal of an
existing ICR that is currently approved by OMB and is due to expire May
31, 2007.  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, 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
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.

Need for and Use of the Collection

2(a).  Need/Authority for the Collection

As required by section 5 of FIFRA, (see 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 unforseen 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;

allow for adequate monitoring of the EUP program; and

  

ascertain the cause/effect relationship when a pesticide is registered
and later found to have adverse effects (as in the case of
phytotoxicity); and 

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

3.	Non duplication, Consultations, and Other Collection Criteria

3(a).  Non duplication

The respondent is not required to submit EUP-related information or data
to any other Federal agency or to any other EPA program offices.  FIFRA
section 7 (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 is publishing a Federal Register (FR)
notice soliciting comment on this information collection activity and
the Agency’s intent to renew the OMB approval of this ICR.  The FR
notice and the proposed renewal ICR as well as any public comment are
located in the docket for this action, which can be accessed at  
HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov 
using the docket indentifier EPA-HQ-OPP-2006-0632.

 

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 arises, 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 Attachment D.   The Agency received no
comments from the representatives listed below during the consultation
period. 

Russell Schneider

Monsanto

  HYPERLINK "mailto:russell.p.schneider@monsanto.com" 
russell.p.schneider@monsanto.com 

	Greg Watson

Syngenta

  HYPERLINK "mailto:greg.watson@syngenta.com"  greg.watson@syngenta.com 

Don Carlson

FMC Corporation

  HYPERLINK "mailto:don_carlson@fmc.com"  don_carlson@fmc.com 

	Jim Barron

Bayer

  HYPERLINK "mailto:jim.barron@bayercropscience.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

(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.

(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

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

(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;

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) ( 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 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

If an application for an EUP is accompanied by a petition for a
tolerance, temporary tolerance, an exemption from the requirement of a
tolerance, or a temporary tolerance exemption, the petition is subject
to fee requirements.  An extension or renewal request for a temporary
tolerance is also subject to a fee requirement.  In March 2004, the
Pesticide Registration Improvement Act (PRIA) of 2003 became effective. 
The goal of this Act is to create a more predictable evaluation process
for affected pesticide decisions, and couple the collection of
individual fees with specific decision review periods. The legislation
also promotes shorter decision review periods for applications including
reduced-risk.  Certain submitted EUP actions are included under PRIA and
the burden hours and costs associated with these activities are
estimated in the Pesticide Registration Fee Waivers

ICR, (OMB Control No.: 2070-0167, EPA ICR No.: 2147.02).    

 

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

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 LD ADVANCE \d3 50
ADVANCE \u3  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 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.	

(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 experimental use permit:

	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. 
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

6(a). Estimating the Respondent Burden

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 attachment F. 

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.   Based on the
respondent activities identified in section 4(b)(ii) above, the burden
hours exhibited on the Master Table in section 6(d) were developed to
represent a typical respondent to the notification and record-keeping
requirements of this ICR.  Respondent burden hours are estimated at
10.10 hours per respondent with a cost of $644.35 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

As stated above, the number of annual estimated respondents
(applicants) is 75, with each spending approximately 10.10 hours
responding.  This total burden is estimated to cost $48,327.45

The overall annual respondent cost associated with this information
collection, based on an estimate of 75 applications per year, is
estimated to be $64,950.  For respondents, the value of labor per hour
for management, technical, and clerical is $100.56, $64.80, and $33.05,
respectively, indexed to 2006 dollars.  Using the Agency’s burden
estimate and the fully-loaded labor rates, the Agency estimates the
applicant costs to be approximately $644.35 per response. 	

	ANNUAL RESPONDENT BURDEN/COST ESTIMATES

Burden Hours (per year)	

TOTAL	

COLLECTION ACTIVITIES

 ADVANCE \d3 	

Mgt. 

$100.86/hr. ADVANCE \u3 	

Tech. 

$64.80/hr.	

Cler. $33.05/hr.	

Hours	

Costs

Read regulations	

0.5	

0.5	

0.0	

1.00	

$82.82

Plan activities	

     0.0	

1.0	

0.0	

1.00	

$64.80

Create information	

     0.0	

2.0	

0.0	

2.00	

$129.60

Gather information	

     0.0	

2.5	

0.0	

2.50	

$162.00

Compile and review	

     0.0	

2.0	

0.0	

2.00	

$129.60

Complete paperwork	

     0.1	

0.5	

0.0	

0.60	

$42.48

Store/maintain data	

     0.0	

0.0	

1.0	

1.00	

$33.05

TOTAL	

0.60	

8.50	

1.00	

10.10	

$644.35

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  	   $4538.70 

(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

 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

Burden Hours (per year)	

TOTAL	

COLLECTION ACTIVITIES

	

Mgt. 

$93.07/hr.	

Tech. 

$66.34/hr 	

Cler. 

$47.17/hr	

Hours	

Costs

Review submitted 

application package	

           0.0	

2.0	

0.0	

2.00	

$132.68

Record submission	

           0.0	

1.0	

0.0	

1.00	

  $66.34

Analyze submission	

           1.0	

8.0	

0.0	

9.00	

$623.79

File submission	

        0.0	

2.0	

1.0	

3.00	$179.85

TOTAL	

        1.0     	

13.00	

1.00	

15.00	

$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

      Total								$75,199.50

6(d).  Bottom Line Hours And Costs / Master Table

	MASTER TABLE

	

TOTAL

	

Hours	

Costs

Respondent Burden/Cost Estimates: 	

757.50	

          $48,327.45

Agency Burden/Cost Estimates:	

1,125	

          $75,199.50

6(e).  Reasons For Changes In Burden

Labor rates for both respondents and Agency personnel in this ICR have
decreased.  The burden hour breakdown remains unchanged from the last
renewal period.  In previous renewal cycles, the Agency only adjusted
the labor rates to account for inflation.  However, for this renewal,
Agency economists have completely re-estimated labor rates, benefits and
overhead costs for both respondents Agency personnel.  This Agency
analysis was completed in July 2006, see attachment F.  The Agency
believes this is a more realistic estimate of the average respondent and
Agency costs.  As a result, there is a decrease of $18,909.55 in the
estimated total annual respondent cost (from $$67,237.00 to $48,327.45).
 This change is an adjustment.

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 757.50 with an average potential per respondent burden of 10.10
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 appear 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.         

Send comments regarding burden estimate or any other aspect of this
collection of information, including suggestions for reducing the burden
to: Director, Collection Strategies Division, U.S. Environmental
Protection Agency (2822T), 1200 Pennsylvania Avenue, NW, Washington,
D.C. 20460.  Include the OMB control number in any correspondence, but
do not submit the requested information or forms to this address.  The
requested information should be submitted in accordance with the
instructions in the Federal Register Notice seeking comment on this ICR.
 Please reference this document by the OMB Control No. 2070-0040 in all
correspondence.

Send comments on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including through the use of automated collection
techniques to the Director, Collection Strategies Division, U.S.
Environmental Protection Agency (2822), 1200 Pennsylvania Ave., NW,
Washington, D.C. 20460; and to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, NW,
Washington, DC 20503, Attention: Desk Officer for EPA.  Include the EPA
ICR number and OMB control number in any correspondence.

ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachment A - EPA Form 8570-17 - Application For An Experimental Use
Permit To Ship And Use A Pesticide For Experimental Purposes Only -
available electronically at   HYPERLINK
"http://www.epa.gov/opprd001/forms/"  http://www.epa.gov/opprd001/forms/
 or in the docket at EPA-HQ-OPP-2006-0632-0002.

Attachment B - FIFRA Section 5 - available electronically at

  HYPERLINK "http://www.epa.gov/epahome/laws.htm" 
http://www.epa.gov/epahome/laws.htm   or in the docket at
EPA-HQ-OPP-2006-0632-0003.

Attachment C - FIFRA Section 7 - available electronically at

http://www.epa.gov/epahome/laws.htm. or in the docket at
EPA-HQ-OPP-2006-0632-0004.

Attachment D - 68 FR 8887 - Application for Experimental Use Permit to
Ship and Use a Pesticide for Experimental Purposes Only; Renewal of
Pesticide Information Collection Activities and Request for Comments
(published February 26, 2003) -  available electronically at

  HYPERLINK
"http://www.epa.gov/fedrgstr/EPA-PEST/2003/February/Day-26/p4523.htm" 
http://www.epa.gov/fedrgstr/EPA-PEST/2003/February/Day-26/p4523.htm  or
in the docket at EPA-HQ-OPP-2006-0632-0005.

Attachment D – Sample Consultation Questionnaire – available only in
the  the docket at EPA-HQ-OPP-2006-0632-0006.

Attachment F – 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’s DD’s, July 2006.
 Available only in the docket at EPA-HQ-OPP-2006-0632-0007.

 

					

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