Document ID: EPA-HQ-OPP-2013-0617-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-09-27T04:00Z

SUPPORTING STATEMENT FOR

AN INFORMATION COLLECTION REQUEST (ICR)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) Title of the Information Collection

Title:  Experimental Use Permits (EUPs) for Pesticides

	

OMB No. 2070-0040				EPA No. 0276.15

1(b)	Short Characterization/Abstract

This Information Collection Request (ICR) is a renewal of an existing
ICR that is currently approved by OMB and is due to expire 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, Fungicide, and Rodenticide Act
(FIFRA) (Attachment A, pp. 58-59).  FIFRA requires that before a
pesticide product may be distributed or sold in the U.S., it must be
registered by EPA.  However, FIFRA section 5 authorizes EPA to issue an
EUP to allow pesticide companies to temporarily ship pesticide products
for experimental use for the purpose of gathering data necessary to
support the application for registration of a pesticide product.  In
general, EUPs are issued either for a pesticide not registered with the
Agency or for a new use of a registered pesticide.

The information collected and reported under an EUP is a summary of that
which is routinely submitted in connection with registration.  The EUP
allows for large scale field testing, if necessary, in order to collect
sufficient data to support registration.  An EUP is not required if the
person conducting the tests does not expect to receive benefits in pest
control.

	

The prospective registrant files EPA Form 8570-17, Application for An
Experimental Use Permit to Ship and Use a Pesticide for Experimental
Purposes Only (see Attachment B) for a permit to generate information or
data necessary to register a pesticide under Section 3 of FIFRA.  This
information from the applicant is necessary in order to grant and
effectively monitor the EUP.  The applicant must also provide the Agency
with a final report on the results of the experimental program which
includes information such as: amount of the product applied; the crops
or sites treated; any observed adverse effects; any adverse weather
conditions which may have inhibited the program; the goals achieved; and
the disposition of containers, unused pesticide material, and affected
food/feed commodities.

If the food/feed treated under the terms of an EUP is to be shipped in
commerce, the applicant must also submit a petition for temporary
tolerance pursuant to section 408 of the Federal Food, Drug, and
Cosmetic Act (FFDCA) (21 U.S.C. 346a) 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, tolerance
related activities are not described in this ICR.

2.	NEED FOR AND USE OF THE COLLECTION

2(a).  Need/Authority for the Collection

As required by section 5 of FIFRA, and Part 172 of Title 40 of the Code
of Federal Regulations (40 CFR Part 172), the information collected and
reported is necessary to evaluate the potential hazard of the product
and to make certain that the permit was issued for genuine experimental
purposes rather than as a form of temporary registration.  (See
Attachment C for a link to the regulations).  To ensure compliance, the
final report is compared with the objectives of the testing program. 
The information also enables EPA to identify whether the treated food or
feed crops will be used in a commercial market.  Such use would require
the existence of a tolerance or the issuance of a temporary tolerance. 
If there is no tolerance, the crop must be destroyed because the use was
for research purposes only.  Since it is common for applicants to
request extensions of EUPs, it is imperative that the Agency has reports
in hand in order to judge the need for such extensions.

Exemptions from EUP requirements:

Under the existing EUP regulations, small-scale experimental uses of
pesticides are presumed exempt from the EUP requirements.  EPA will not
require an EUP for a substance or mixture of substances being put
through laboratory or greenhouse tests, or fewer than one surface acre
per pest for terrestrial tests or fewer than ten acres per pest for
aquatic tests, in which the sole purpose under the following small scale
field testing scenarios:

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

Test plots may be as large as ten acres per pest if the effect of each
pesticide on several pests is being investigated at a different time for
each pest.  However, if pesticide effects on more than one pest are
being investigated all at the same time, the test plot may not exceed
ten acres in size.  Furthermore, any food or feed crops involved in or
affected by the tests must be destroyed or consumed only by experimental
animals unless a tolerance or exemption from a tolerance has been
established.

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

Water bodies may be as large as one acre per pest if the effect of each
pesticide on several pests is being investigated at a different time for
each pest.  However, if pesticide effects on more than one pest are
being investigated all at the same time, the water body may not exceed
one acre in size.  Bodies of water involved in or affected by the tests
may not be used for irrigation, drinking water supplies, or body contact
through recreational activities.  In addition, pesticides may not be
tested in waters that contain or which affect any fish, shellfish or
other plants or animals which may be taken for food or feed unless a
tolerance or exemption from tolerance exists for the test product.

Animal Treatment Uses: 

Tests may be conducted only in cases where experimental animals will not
be used for food or feed unless a tolerance or exemption from tolerance
exists for the test product.

Other Uses:

In instances where testing operations do not accurately reflect whether
the testing is to be considered small-or large-scale acreage limits, the
Agency will determine on a case-by-case basis whether an exemption from
the requirement from an EUP is appropriate.

The exemptions described above are not definitive, but 40 CFR 172.3
gives EPA discretionary authority to exempt particular testing
operations from the EUP requirements under other conditions.  40 CFR
172.3 also allows EPA discretionary authority to require EUPs for
testing operations even when the exemption conditions of 40 CFR 172.3(b)
and (c) are met.

EUP for Small-scale Field Testing of Microbial Pesticides:

The Agency may require an EUP for small scale field testing of certain
unique microbial pesticides (i.e., genetically-altered and
non-indigenous microbial pest control agents) because of the potential
concern for microorganisms to reproduce and multiply in the environment
and the potential for these microbial pesticides to cause unforeseen
adverse impacts.  Prior to the initiation of any small scale field
testing involving genetically-altered or non-indigenous microbial pest
control agents, the research organization, company, or individual must
submit a notification to the Agency so that a determination can be made
as to whether an EUP is required.  The requirements for a EUP for field
testing of microbial pesticides are found in 40 CFR 172.43-172.59. 
These requirements differ significantly from the EUP requirements for
testing other pesticides.

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

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

Determine whether a new request for an EUP or a renewal, extension or
amendment of an EUP, if requested, is justified;

allow for adequate monitoring of the EUP program; and 

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

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

3.	NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3(a).  Non duplication

The respondent is not required to submit EUP-related information or data
to any other Federal agency or to any other EPA program offices.  FIFRA
section 7, however, does require annual pesticide production reports
from all persons who produce pesticides (see Attachment A, p. 65).  The
pesticide material produced in conjunction with an EUP would be included
in these 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, consultation and/or dialogue
between the respondent and EPA occurs on an informal, ongoing "as
needed" basis, primarily during the submission and review of the
application for an EUP.  Historically, when technical, administrative or
other problems arise, the respondent is given ample opportunity to
inform the agency and vice versa. This communication between both
parties may take place either in a telephone conversation or in a
meeting setting, but not necessarily by a prescribed schedule.

In addition, as required under 5 CFR 1320.8(d)(1), EPA staff will
contact several representatives of pesticide registrants by e-mail to
seek feedback on the EUP information reporting requirements and the
regulatory burden estimates expressed by the Agency in this ICR.  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 ICR supporting statement.    

3(d).  Effects of Less Frequent Collection

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

3(e).  General Guidelines

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

3(f).  Confidentiality 

When trade secret information or Confidential Business Information (CBI)
is provided to the Agency, such information is protected from disclosure
under FIFRA Section 10, as amended and EPA's confidentiality regulation
in 40 CFR Part 2, Subpart B.  Data submitted to the Agency are handled
strictly in accordance with the FIFRA CBI Security Manual.  This manual
contains instructions relative to all contact with confidential
documents, including responsibility of EPA employees; physical security
measures; CBI materials within EPA, such as CBI typing procedures
(documents typed internally or on contract); and division internal
procedures.  The manual dictates that: (1) all CBI must be marked or
flagged as such, (2) all CBI must be kept in secure, double-locked
areas, and (3) all CBI for destruction must be cleared by a document
control officer and placed in the Office of Chemical Safety and
Pollution Prevention paper shredder.

3(g).  Sensitive Questions

No information of a sensitive or private nature is requested in
conjunction with this information collection activity.  Further, this
information collection activity complies with the provisions of the
Privacy Act of 1974 and OMB Circular A-108.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a).  Respondents/NAICS Codes

 The North American Industrial Classification System (NAICS) code for
respondents participating in this data collection is 325320 (Pesticide
and other Agricultural Chemical Manufacturing).

4(b).  Information Requested

4(b) (i)	Data Items

Form 8570-17 must be submitted to EPA with each EUP application. The
type of information to be submitted with the application depends on
whether the product is already registered and whether a tolerance is
required for the testing covered under the EUP.  40 CFR 172.4 lists the
information that is required.

An application for an EUP may be submitted by any company or person
wishing to generate the information necessary as required by section 3
of FIFRA in accordance with the regulations found in 40 CFR 172.2(a). 
The applicant may be a potential registrant, an independent researcher
or testing laboratory, or any similar agent or consultant of a
manufacturer.  Applications must be submitted to the following address:

Document Processing Desk (EUP)

U.S. Environmental Protection Agency

Office of Pesticide Programs (7504P)

U.S. Environmental Protection Agency

1200 Pennsylvania Ave. NW

Washington, D.C. 20460

Information Required in All EUP Applications:

Each EUP application must contain the following information together
with a completed copy of 8570-17:

Applicant’s name and address;

The registration number of the product, if it has been registered
(information requirements for unregistered products are listed below in
a separate section);

Purpose or objectives of the proposed testing; 

Detailed description of the proposed testing program including the
following test parameters:

Pest organism(s) involved;

Amount of pesticide proposed to be used;

Crops, fauna, and flora involved;

Sites and modes of pesticide applications;

Pesticide dosage rates;

Location of test site, including States;

Number of acres in test site;

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

Proposed dates of the testing; and

How the testing will be supervised.

Name, street address, telephone number and qualifications of program
participants, including those not employed by the applicant;

Names and street addresses of cooperators (persons owning or controlling
application sites and granting permission to permittees to use these
sites);

Results of prior testing of product by applicant to determine:

Toxicity and effects in or on target organisms; 

Toxicity and effects in or on non-target plants, animals and insects at
or near the application site; and 

Adverse effects to the environment from application of this product; and

How the applicant intends to store and dispose of unused pesticide and
containers from the proposed experimental use.

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

New data required to be submitted for EUP applications for field testing
of both unregistered chemical and plant-incorporated pesticides (PIP) to
show that the pesticide during testing will not cause an unreasonable
adverse effect to man and the environment are substantially greater than
registered pesticides that have already met these requirements of FIFRA
for their labeled uses.

In addition to the information listed immediately above, when the
product to be tested has not been registered, the applicant must provide
the following information:

A complete confidential statement of composition giving the composition
of the formulation to be tested as a tabulation of the names and
percentage by weight of each ingredient, both active and inert;

Chemical and physical properties of each active ingredient of the
formulation being tested including the analytical methods to be used to
determine these;

Available data on the rate of decline of residues on the treated crop or
site together with other information relevant to determining when
workers can safely re-enter treated areas; and

Available toxicity and exposure data, including human epidemiological
data, relevant to assessing the potential of the product to cause injury
to users and other people who may be exposed.

When Testing May Result in Pesticide Residue on Food:

	When the product to be tested is to be used in such a manner to leave
residue on food or feed, the applicant has three options for determining
that treated crops are not used for food or feed use without a
tolerance:

The applicant may submit evidence that a tolerance or a tolerance
requirement exemption has been established under Section 408 of the
FFDCA;

The applicant may submit a petition for a new tolerance or for an
exemption from the requirement for a tolerance established under Section
408 of the FFDCA (Chapter 7 of this document, Tolerance Petitions,
describes this process in detail); and

The applicant may certify that the food or feed derived from the
experimental program will be destroyed or will be fed only to
experimental animals which will be destroyed. Alternatively, the
applicant may certify that the food or feed derived from the
experimental program will be disposed of in another manner which does
not endanger man or the environment; the permit application shall
specify the means of such disposal.  

EUP applications should be submitted to EPA as far in advance as
possible of the first shipping date, at least six months in advance. 
FIFRA section 5(a) requires EPA to complete EUP reviews within 120 days,
and failure to provide the appropriate information or data may delay
processing of the EUP beyond this date.

Labeling Requirements:

All pesticides shipped or used under an EUP must be labeled with
directions and conditions for use including the following:

The prominent statement “For Experimental Use Only”;

The Experimental Use Permit Number;

The statement “Not for sale to any person other than a participant or
cooperator of the EPA-approved Experimental Use Program”;

The name, brand or trademark;

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

The net contents;

An ingredient statement; 

Warning or caution statements;

Any limitations on entry of persons into treated areas;

The establishment registration number, except in those cases where
application of the pesticide is made solely by the producer; and

The directions for trial use.

Extensions or renewal of EUPs:

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

Fee Requirements:

If an application for an EUP is accompanied by a petition for a
tolerance, temporary tolerance, an exemption from the requirement of a
tolerance, or a temporary tolerance exemption, the petition is subject
to fee requirements.  An extension or renewal request for a temporary
tolerance is also subject to a fee requirement.  In October 2012, the
Pesticide Registration Improvement Act (PRIA) of 2012 became effective. 
The goal of this Act is to create a more predictable evaluation process
for affected pesticide decisions, and couple the collection of
individual fees with specific decision review periods. The legislation
also promotes shorter decision review periods for applications including
reduced-risk.  Certain submitted EUP actions are included under PRIA and
the burden hours and costs associated with these activities are
estimated in the Pesticide Registration Fees Program ICR, (OMB Control
No.: 2070-0179, EPA ICR No.: 2330), and are not duplicated in this ICR.

Use of an EUP Product on Food or Feed Crops:

A product may only be used on food or feed crops if the Agency has
issued tolerances or exemptions from requirements for tolerances for all
inert ingredients, metabolites, and degradation products, as well as
active ingredients. If the proposed labeling bears instructions for use
of the product on food or feed crops, or if the intended use of the
product results or may be expected to result, directly or indirectly, in
pesticide residues in or on food or feed, applicants must submit a
statement indicating whether a tolerance or an exemption from the
requirement of a tolerance has been issued by the Agency under section
408 of the FFDCA.  

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

Suggested Format for an EUP Application:

The following format is an example of an acceptable EUP application. Not
all of the items are necessary in every case. Depending on whether the
product being tested is already registered with EPA, and whether a
tolerance is necessary because treated crops will be used as food or
feed, several of these entries may not be necessary.

Section A - This section should include a data sheet detailing the
chemical and physical properties of the test chemical along with a
complete statement of the names and percentages by weight of each active
and inert ingredient in the formulation to be shipped. 

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 EUP:

Once the permit is issued and the pesticide testing is underway, the
applicant is required to track the results at each test site and submit
a final report to EPA which shall include (40 CFR 172.8):

All data gathered during the testing program. Although field notes need
not be included in this report, they must be kept available for EPA
review upon request.

A report of how pesticide containers and unused pesticides were disposed
of, including the quantity disposed of, disposal sites and disposal
methods.

In the case where meat-producing animals or birds are treated by or
exposed to an experimental use pesticide, the applicant must report the
name and location where the animals will be processed to the U.S.
Department of Agriculture, Animal and Plant Health Inspection Service,
Washington, DC, 20250.

The applicant must also report any adverse effects from use of or from
exposure to the pesticide being tested.

EPA may require advance notice from the applicant of the intended test
dates, sites and times. The applicant must also allow EPA access to the
testing site to determine whether the testing complies with the terms
and conditions of the permit.	

	4(b) (ii)	 Respondent Activities

	The following are the activities to be conducted by a respondent
(applicant) in order to comply with the provisions of EPA Form 8570-17.

Activity	Explanation

read FIFRA Section 5 

and 40 CFR 172.8(b) 	become familiar with the legislation and
regulations and determine the requirements as they pertain to a  
proposed experimental use of a pesticide

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

create information	develop information required for notification

gather information	gather information required for the notification or
containment records

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

complete paperwork	prepare notification document or containment record

record, disclose, and display information	submit notification to OPP

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

5.	THE INFORMATION COLLECTED – AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT

5(a).  Agency Activities

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

Activity	Explanation

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

record submission	record submission in tracking system

analyze submission	conduct scientific reviews of data

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

5(b).  Collection Methodology and Management

A submitted EUP package usually includes three parts: an EPA Application
Form 8570-17, the product label, and, in most cases, supporting data. 
The application form and the product label are pin-punched by date by
the Front-End Application Processing Unit for initial screening.  If
everything is found to be complete, the proposed EUP is given a file
symbol, entered into the appropriate tracking system, and a registration
jacket is created identifying the document by the appropriate Product
Manager (PM) for the chemical being employed.  The accompanying data is
identified and processed for review. 

The three-part EUP package is sent to the designated PM who is
responsible for managing the registration action.  The testing program
and labeling program are reviewed by the PM while the data portion is
routed for scientific review to the appropriate discipline.  On
completion of the scientific review, the PM receives a written analysis
of the data.  If the data is found to be acceptable, an EUP is issued. 
If not, the EUP request is rejected and the PM then notifies the
applicant in writing of the deficiencies before the EUP request can be
resubmitted.  The file is then updated in the tracking system to reflect
the latest status and the registration jacket is stored in the file
room.

5(c).  Small Entity Flexibility

The Agency recognizes that many small businesses are involved in
research and development activities with pesticides.  In setting forth
the notification requirements, EPA has sought to minimize the regulatory
burden on research and development activities.  Toward this end, the
Agency has identified the minimum amount of data to be submitted to
permit a scientific assessment of the proposed research.  Much of this
information already would be available to the respondent as part of the
normal information developed during the research and development stage. 
These data requirements are flexible and may be adjusted as appropriate
to the specific product under review.  As an alternative to submitting a
Notification, an applicant may apply for, and obtain an EUP before
conducting a field test with a pesticide.  Because the notification
requirements have been designed from the outset to minimize the burden
on respondents, as a result, there are no special measures taken for
small businesses since the burden is considered to be at a minimal
level.

5(d).  Collection Schedule

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

6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a).   Estimating the Respondent Burden

The burden associated with this collection of information is described
in detail in the following sections.  In calculating the respondent
burden, EPA will provide burden estimates for those who apply for
chemical pesticide EUPs and for those who apply for plant-incorporated
protectants (PIPs) EUPs.  Consultations during the previous renewal
cycle (EPA No. 0276.14) and a review of the Agency process for EUP data
submissions indicated the need for the creation of a second response
type specifically for PIPs because the requirements for field testing of
PIPs tend to be more intensive than for chemical pesticides and because
of the time needed to assemble and format the data to fulfill PR Notice
2011-3 requirements (Attachment F).  

Based on the number of EUP applications received in fiscal years 2010,
2011 and 2012, the estimated annual number of responses for chemical
pesticides is 8 and the estimated number of EUP applications for PIPs is
2 for each year of the three year renewal cycle.  Total respondent
burden hours are estimated at 32.8 hours per response for chemical
pesticides at a cost of $1,970.52 per response, and 147 hours per
response for PIPs 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 employing
publicly-available data to provide more accurate estimates and allow
easy replication of the calculations. 

Methodology: The methodology uses data on each sector and labor type for
an Unloaded wage rate (hourly wage rate), and calculates the loaded wage
rate (unloaded wage rate + benefits), and the fully loaded wage rate
(loaded wage rate + overhead).  Costs are indexed to 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 Employment and Wage Estimates from the
Bureau of Labor Statistics (BLS) at  HYPERLINK
"http://www.bls.gov/oes/current/oes_nat.htm"
http://www.bls.gov/oes/current/oes_nat.htm .  For loaded wage rates,
benefits represent 44% of unloaded wage rates, based on benefits for all
civilian non-farm workers, from  HYPERLINK
"http://www.bls.gov/oes/current/oes_nat.htm"
http://www.bls.gov/oes/current/oes_nat.htm .  Fully loaded wage rates
include an additional 50% on top of the loaded wage rate to capture
overhead costs (EPA guidelines 20-70%).  The data and calculations for
wage rates used in this document are presented in Attachments G and H. 

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

To determine respondent costs, the Agency used the BLS estimates of
labor rates for the NAICS code for Pesticide Registrants (NAICS 325300).
 The managerial labor rate is based on the SOC for management
occupations; the technical labor rate is based on the SOC for life,
physical and social science occupations; and the clerical labor rate is
based on the SOC for office and administrative support occupations.  The
labor rates are fully loaded and indexed to May 2012 dollars (See
Attachment G).  The fully 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, NAICS: 325300).

Using the Agency’s burden estimate and the fully-loaded labor rates,
the Agency estimates the applicant labor costs to be approximately
$1,970.52 per chemical pesticide EUP response, and $9,054.07 per PIPs
EUP response. The total labor cost associated with the paperwork burden
of the EUP program is estimated to be $33,872 (15,764 + 18,108).

RESPONSE BURDEN AND COST ESTIMATES PER EUP APPLICATION FOR CHEMICAL
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 

ANNUAL BURDEN: 32.8 Hours per Response x 8 Responses per 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 APPLICATION 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 review	 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 per Response x 2 Responses per Year = 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 estimates affected by rounding in calculation.

	

	6(c)   Estimating Agency Burden and Costs

For this ICR renewal, the Agency is using data on internal OPP Divisions
that provide significant support and analysis for the EUP ICR program. 
This data is taken from the Time and Attendance Information System
(TAIS), which archives the Agency’s Full Time Equivalents (FTEs) for
most OPP program activities.  The Agency believes that using data from
the TAIS reflects the changes to the internal operations for
implementing and administering EUP activities.  The major impetus for
internal program realignment was to implement the requirements of the
Food Quality Protection Act of 1996 and the Pesticide Registration
Improvement Act of 2012 (PRIA) as reauthorized.

Using this 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 FTEs 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 System (NAICS) code for the Federal Executive Branch
(NAICS 999100).  The managerial labor rate is based on the Standard
Occupational Code (SOC) for management occupations; the technical labor
rate is based on the SOC for life, physical and social science
occupations; and the clerical labor rate is based on the SOC for office
and administrative support occupations.  The labor rates are fully
loaded and indexed to May 2012 dollars (See Attachment H).  The fully
loaded hourly 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 occupations the fully 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 multiplied by the cost per
FTE.  This represents the Agency’s estimate of its cost that will
result from EUP activities for each of the next three years. 

ANNUAL BURDEN:  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 Hours 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 is 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 renewal ICR
entitled Experimental Use Permit (EUP) for Pesticides is estimated to be
556 hours with an average potential per response burden of between 32.8
hours for chemical pesticides and 147 hours for plant-incorporated
protectants.  “Burden” is defined in 5 CFR 1320.3(b).  The agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.  OMB control numbers for certain EPA regulations in
title 40, after initial display in the final rule, are listed in 40 CFR
part 9 and appear on the information collection instrument as
applicable, i.e., form or instructions, and in the Federal Register.    
    

The Agency has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2013-0617, which is available for online viewing at  
HYPERLINK "http://www.regulations.gov"  www.regulations.gov , or in
person viewing at the OPP Docket in the EPA Docket Center, EPA West, Rm.
3334, 1200 Pennsylvania Ave, NW, Washington, DC 20460-0001. This docket
facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays.  The docket telephone number is (703)
305-5805.  

You may submit comments regarding the Agency's need for this
information, the accuracy of the provided burden estimates and any
suggested methods for minimizing respondent burden, including the use of
automated collection techniques. Comments may be submitted to EPA
electronically through http://www.regulations.gov or by mail addressed
to OPP Regulatory Public Docket (7502P), Office of Pesticide Programs
(OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460–0001.  You can also send comments to the Office
of Information and Regulatory Affairs, Office of Management and Budget,
725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for
EPA.  Include docket ID No. EPA-HQ-OPP-2013-0617 and OMB control number
2070-0040 in any correspondence, but do not submit EUP applications and
any related information (e.g., forms, reports, etc.) to these addresses.
 The information described in this ICR is to be submitted to the address
identified in section 4(b) of this supporting statement.

7.	ATTACHMENTS to this SUPPORTING STATEMENT

	All of the attachments listed below can be found in the docket for this
ICR, identified as Docket ID Number, EPA-HQ-OPP-2013-0617, which is
accessible electronically through   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov .  On the main page,
select Advanced Search from the menu bar at the top and select Docket
Search.  Enter the Docket ID Number in the Docket ID field.  Click on
the Submit button.  From the results page, you will be able to link to
the docket view or directly open select documents found in the docket.

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

  HYPERLINK "http://www.epa.gov/opprd001/registrationmanual/FIFRA.pdf" 
http://www.epa.gov/opprd001/registrationmanual/FIFRA.pdf 

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

  HYPERLINK "http://www.epa.gov/opprd001/forms/8570-17.pdf" 
http://www.epa.gov/opprd001/forms/8570-17.pdf   

Attachment C:	40 CFR Part 172 - Experimental Use Permits

(e-CFR:    HYPERLINK
"http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=7fd873207444a629c7cb2c2
079717f48&rgn=div5&view=text&node=40:25.0.1.1.21&idno=40" 
http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=7fd873207444a629c7cb2c20
79717f48&rgn=div5&view=text&node=40:25.0.1.1.21&idno=40 ) 

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

Attachment E:	PLACEHOLDER - Consultations Responses

Attachment F:	Pesticide Registration (PR) Notice 2011-3: Standard Format
for Data Submitted Under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and Certain Provisions of the Federal Food,
Drug, and Cosmetic Act (FFDCA)

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

August 26, 2013

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