Document ID: EPA-HQ-OPP-2008-0927-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-03-10T04:00Z

SUPPORTING STATEMENT FOR

AN INFORMATION COLLECTION REQUEST (ICR)

1.	Identification of the Information Collection

1(a).  Title of the Information Collection

Title:	Tolerance Petitions for Pesticides on Food/ Feed Crops and New
Inert Ingredients 

EPA ICR No. 0597.10		 OMB Control No. 2070-0024

1(b).  Short Characterization/Abstract

The use of pesticides to increase crop production often results in
pesticide residues in or on the crop.  To protect the public health from
unsafe pesticide residues, the Environmental Protection Agency (EPA)
sets limits on the nature and level of residues permitted pursuant to
section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) (See
Attachment A).  A pesticide may not be used on food or feed crops unless
the Agency has established a tolerance (maximum residue limit) for the
pesticide residues on that crop, or established an exemption from the
requirement to have a tolerance.  

Under the law, EPA is responsible for ensuring that the maximum residue
levels likely to be found in or on food/feed are safe for human
consumption through a careful review and evaluation of residue chemistry
and toxicology data.  In addition, EPA must ensure that adequate
enforcement of the tolerance can be achieved through the testing of
submitted analytical methods.  If the data are adequate for EPA to
determine that there is a reasonable certainty that no harm will result
from aggregate exposure, the Agency will establish the tolerance or
grant an exemption from the requirement of a tolerance.  

There are basically three types of tolerance actions:

Permanent tolerance (or an exemption from the requirement for a
permanent tolerance) for residues which would result from a pesticide
use registered under FIFRA.  These tolerances can be established for raw
and processed foods and they can address both active and inert
ingredients in pesticides.  The vast majority of these actions are taken
in response to petitions, but the Agency may also initiate such actions.

Temporary tolerance (or an exemption from the requirement for a
temporary tolerance) to permit the sale of commodities containing
residues resulting from authorized experimental use of an unregistered
pesticide.  In the absence of such a tolerance or exemption, all such
commodities must be destroyed.  In submitting an application for
Experimental Use Permit (EUP), the applicant may also request that the
Agency establish a tolerance or an exemption from the tolerance
requirement.  This ICR does not cover EUP related tolerance information
collection activities, which are covered by the ICR entitled,
Application for Experimental Use Permit (EUP) to Ship and Use a
Pesticide for Experimental Purposes Only (OMB Control #2070-0040, EPA
ICR No. 0276).

Time-limited tolerance (or an exemption there from) to permit the sale
of commodities containing residues resulting from a pesticide whose use
was authorized under Section 18 of FIFRA.  Under FIFRA (18, EPA may
allow States to use a pesticide for an unregistered use for a limited
time if EPA determines that emergency conditions exist.  The Food
Quality Protection Act of 1996 (FQPA), which amended the two primary
statutes regulating pesticides, i.e., FFDCA and the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA), requires EPA to establish
tolerances to cover all pesticide residues in food, even residues
resulting from emergency uses (see Attachment B).  Although the Agency
initiates these tolerance actions, these actions are taken in response
to petitions for the Agency to issue an action under FIFRA (18.  This
ICR does not cover information collection related to FIFRA (18 tolerance
activities, which is collected under the ICR entitled, Application and
Summary Report for an Emergency Exemption for Pesticides (OMB Control
#2070-0032, EPA ICR No.0596).    

This ICR only applies to the information collection activities
associated with the submission of a petition for a tolerance action. 
While EPA is authorized to set pesticide tolerances, the Food and Drug
Administration (FDA) is responsible for their enforcement.  Food or feed
commodities found to contain pesticide residues in excess of established
tolerances are considered adulterated, and are subject to seizure by
FDA, and may result in civil penalties.

2.	Need For and Use of the Collection

2(a).	Need/Authority for the Collection

The tolerances for pesticide residues in food or feed are set primarily
under the authority of section 408 of the Federal Food, Drug and
Cosmetic Act (FFDCA), as amended.  The Agency takes these tolerance
actions either on its own initiative pursuant to FFDCA (408(e) or in
response to a petition filed pursuant to FFDCA (408(d).  The regulations
covering tolerances are contained in Title 40 of the Code of Federal
Regulations (CFR) Part 180.  Actual listings of individual tolerances by
chemical are also found in Part 180 (See Attachment C).

Under FFDCA (408(d), any person may file a petition with EPA, proposing
the issuance of a regulation establishing, modifying, or revoking (a) a
tolerance for a pesticide chemical residue in or on food, or (b) an
exemption from the requirement to have a tolerance for such residue. 
The Agency publishes a notice of receipt for such petitions in order to
provide an opportunity for public comment on the request, and then
either issues a final regulation, or a notice denying the petitioner’s
request.  FFDCA (408(d)(4) directs the Agency to issue a final
regulation establishing, modifying, or revoke a tolerance for the
pesticide chemical residue or an exemption of the pesticide chemical
residue from the requirement of a tolerance,  or issue an order denying
the petition.

Under FFDCA (408(e), at any time the Agency may issue a regulation
establishing, modifying, suspending, or revoking (a) a tolerance for a
pesticide chemical residue in or on food, or (b) an exemption from the
requirement to have a tolerance for such residue.  When initiating such
actions, FFDCA (408(e)(2) requires the Agency to issue a notice of
proposed rulemaking to provide an opportunity for public comment.

FQPA requires that tolerances be set at a level to ensure that there is
“a reasonable certainty that no harm will result from aggregate
exposure.”  Among other things, FQPA requires EPA to consider a number
of factors when setting such tolerances or registering pesticide
products, including:

special protection for infants and children;

aggregate exposure and risk from foods and other known sources, such as
drinking water and household pesticide use;

consideration of common mechanisms of toxicity (some chemicals have
different molecular structures but cause deleterious effects in the same
manner); and,

Consideration of endocrine disruptor effects.  

The collection of information covered by this ICR is needed to ensure
that the statutory requirements related to tolerances can be met by the
public and EPA.  Food or feed commodities found to contain residues of a
pesticide without or in excess of established tolerances are considered
adulterated, and are subject to seizure by FDA, and may result in civil
penalties.

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

The FQPA directs the Agency to consider aggregate exposures from dietary
and non-occupational sources when assessing the risks of a chemical and
setting tolerances.  In addition to dietary exposure, such sources as
drinking water and residential lawn care use need to be considered.  EPA
must make the statutory determination that the resulting pesticide
residues in food or feed will result in a reasonable certainty of no
harm effects of human health from aggregate exposure through dietary,
non-occupational, and drinking water routes of exposure before
establishing the tolerance. EPA applies the FQPA standard to all
tolerances for newly-registered chemicals and food uses.

EPA does not require registrants to submit any additional information
under this ICR in order for the Agency to determine that there is a
reasonable certainty that no harm will result from aggregate exposure. 
However, Section 408 of FFDCA requires petitioners submit “an
information summary of the petition and of the data, information and
arguments submitted or cited in support of the petition.”  FQPA
requires EPA to consider additional information in order to make the
necessary regulatory decisions.  To allow for the most efficient
processing and review of tolerance petitions, the Agency provides a
description of the types of information it considers helpful in the
appendices to Pesticide Registration (PR) Notice No. 97-1 (See
Attachment D).  EPA encourages petitioners to submit supplemental
information with their petitions to help EPA determine whether there is
a reasonable certainty that no harm will result from aggregate exposure.
 

EPA uses the data to make decisions about the tolerance petitions.  The
Agency’s risk managers review, among other things, the regulatory
aspects of each petition and coordinate scientific review of the
supporting data.  Agency residue chemists and toxicologists review all
the applicable data.   As a result of these reviews, EPA is able to make
the statutory determination that the resulting pesticide residues in
food or feed will not cause unreasonable adverse dietary effects on
human health. 	

3.	Non Duplication, Consultations, and Other Collection Criteria

3(a).	Non duplication

To avoid potential overlap between the requirement of developing data in
support of a tolerance petition and the development of data required for
the registration of a pesticide under FIFRA, EPA allows the use of data
required to support a tolerance petition that are already archived in
EPA records for use as part of a FIFRA registration of a pesticide to be
used in a like manner and in the same use pattern.

3(b).	Public Notice Required Prior to ICR Submission to OMB		

	Pursuant to 5 CFR 1320.8(d), EPA will publish a Federal Register (FR)
notice announcing this proposed information collection activity and
providing a 60-day public comment period.  The Agency has established a
public docket for this proposal, which can be accessed at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov , using the
docket identifier EPA-HQ-OPP-2008-0927.  Comments received will be given
consideration when completing the supporting statement submitted to the
OMB.

3(c).	Consultations

In addition to the public notice that EPA will publish in the Federal
Register concerning the renewal of this ICR, the Agency will consult, as
required under 5 CFR 1320.8(d)(1), with stakeholders who actively
interact with the Agency through the use of this collection instrument. 
A copy of the questions the EPA will ask as part of the consultations
are listed in Attachment E.

  	3(d).	Effects of Less Frequent Collection

Not applicable.  This activity is conducted only once per "event," so a
less frequent collection is not possible.

3(e).  General Guidelines

Due to the statutory mandate for the permanent retention of supporting
chemistry and toxicological data related to pesticides, the data
included in petitions must be maintained for the life of the pesticide. 
This mandate exceeds the PRA guideline that records be retained for no
more than three years.

OMB’s regulations require agencies to provide a statement indicating
whether the proposed collection of information involves the use of
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses, and an explanation of the decision
(5 CFR 1320.5(a)(iii)(E)).  Registrants have the option to
electronically submit underlying study data required by the Agency in
support of the tolerance petition process. Under this option,
petitioners need only submit 2 two paper copies if they submit the
required study data in Adobe Acrobat Portable Document Format (PDF) on a
compact disc.  As EPA staff has become familiar with the electronic
submission process and the technology, OPP believes this option is
allowing the Agency to operate efficiently in the regulation of
pesticides through electronic delivery, review, interchange capability
and archiving of data supporting the petitions. Under this option, the
time normally required for OPP to complete its review of the data should
be shortened, thereby allowing faster regulatory decision-making.

The Agency believes that petitioners have become familiar with the
electronic submission process and the technology, and that they are able
to prepare their data submissions in less time.  The OPP expects
petitioners to spend less time and money on preparing copies and using
the hybrid paper-electronic submission option, and that they are
benefiting from the efficiencies that EPA expects to experience during
data reviews.

At this time of this renewal, OPP is not offering a fully electronic
submission option.  It is, however, beginning the process of defining
requirements for electronic submission of studies as well as other
elements of applications and petitions.  This includes efforts to
develop information technology approaches to adequately protect FIFRA
Confidential Business Information submitted over the Internet.  In the
interim, please see EPA’s Electronic Submission Interim Guidance
documents (Attachment F).

3(f).  Confidentiality

Trade secret or confidential business information (CBI) is frequently
submitted to the EPA in this program because submissions usually include
the manufacturing process, product formulation, and supporting data. 
When such information is provided to the Agency, the information is
protected from disclosure under FIFRA Section 10.  CBI data submitted to
the EPA is handled strictly in accordance with the provisions of the
FIFRA Confidential Business Information Security Manual.

3(g).  Sensitive Questions

Not applicable.  No information of a sensitive or private nature is
requested in this information collection activity.

4.	The Respondents and the Information Requested

4(a).  Respondents/NAICS Codes

Respondents to this information collection activity include anyone who
files a petition asking the Agency to take a specific tolerance action. 
Although such petitions typically come from those businesses engaged in
the manufacturing of pesticides, the Agency may also receive petitions
from other entities, including the Interregional Research Project No.4
(IR-4), third party registrants, grower groups, importers or other
governments, and concerned citizens.

Although it is impossible to identify all the North American Industrial
Classification System (NAICS) codes for all of the potential
respondents, the NAICS code for the most frequent type of respondent is:

 

Respondent

Category	

NAICS code	

Examples of potentially 

affected entities

Pesticide and other agricultural chemical manufacturing	

325320	

Individuals or entities engaged in activities related to the
registration of a pesticide product.

4(b).  Information Requested

(i)    Data Items, Including Record Keeping Requirements

In addition to a cover letter and fee, a tolerance petition must include
the following nine parts:

	

Chemical identity	

The name, chemical identity, and composition of the pesticide chemical. 
If the pesticide chemical is an ingredient of a pesticide, the complete
quantitative formula of the resulting pesticide product should be
submitted.  The submission of this information does not restrict the
application of any tolerance or exemption granted to the specific
formula(s) submitted.

Chemical use  	

The amount, frequency, and time of application of the pesticide
chemical.

Safety reports	

Include reports of investigations made with respect to the safety of the
pesticide chemical.  These reports should include, when necessary,
detailed data derived from appropriate animal or other biological
experiments in which the methods used and the results obtained are
clearly set forth.

Residue test results	

The results of tests on the amount of residue remaining, including
description of the analytical method used.  (See 40 CFR 180.34 for
further information about residue tests.)

Residue removal 	

Practicable methods for removing residue that exceeds any proposed
tolerance.

Proposed tolerance 	

Proposed tolerances for the pesticidal chemical if specific tolerances
are being proposed.

Grounds for petition	

Reasonable grounds in support of the petition.

Supplemental information	

Analysis of factors relevant to the provisions of FQPA

Summary	

An informative summary of the petition or application, including a
summary of the supporting data, information, accompanying rationales,
and a statement providing permission to publish such summary.  This
summary should indicate how approval of the petition will meet the
statutory determination required of “reasonable certainty of no
harm.”

There are no forms associated with this information collection. The data
compiled should be submitted as separate sections, suitably identified. 
If data have already been submitted with an earlier application, the
petitioner may incorporate it by reference in the present petition.  The
petition must be submitted in triplicate.  The petitioner must also show
that the pesticide is already registered for the related food or feed
use, or that an application for the registration of a pesticide for the
related food or feed use has been submitted pursuant to FIFRA section 3
(See Attachment G).

(ii)   Respondent Activities

In order for a tolerance to be established for a pesticide product, a
respondent (petitioner) must do the following:

	

Review regulations	

Read applicable FFDCA provisions and related tolerance regulations;

Prepare information	

Prepare supplemental information to aid Agency decision-making
concerning a tolerance petition, as encouraged by the Agency and
outlined in Pesticide Registration Notice 97-1.

If necessary, this may involve: 

conducting additional toxicological or residue chemistry studies

developing analytical methods

Prepare correspondence	

Generate petition correspondence, including preparing an informative
summary to be published in the Federal Register;

Review Agency comment	

If applicable, read any Agency notice of petition deficiency;

Respond to Agency comment	

Submit supplemental information or petition, or request that petition be
filed as submitted; and

Maintain records	

Store, file and maintain the information submitted.

The Information Collected - Agency Activities, Collection Methodology,
and Information Management

5(a)	Agency Activities

Upon receipt of a tolerance petition, EPA performs the following
activities:

Log Receipt 	

Log petition and associated fee.

Review petition	

Screen petition, fee, and supporting data for completeness and
acceptability; resolve any deficiencies with petitioner.

Prepare Federal Register notice	

Upon acceptance, publish notice of filing in Federal Register.

Review data 	

Review supporting residue chemistry, toxicology data and other
assessments received.

Test analytical methods	

Test proposed analytical methods in EPA laboratories, if they are new or
modified.

Integrate review	

Integrate data reviews and determine adequacy; resolve any deficiencies
with petitioner, make registration decision.

Prepare decision document	

Prepare decision document, Federal Register Notice with rule
establishing the tolerance(s) or exemption(s).

Maintain records	

Record all actions and decisions in official records.

5(b).	Collection Methodology and Management

Specific studies submitted as part of petition are catalogued and
archived as they are received.  When the Agency review is complete, the
remaining portions of the petition record, including correspondence
subsequent to filing and all reviews, notices, and other materials
created by EPA in the course of its review, are catalogued and archived.
 All petition materials are retained permanently.

5(c).	Small Entity Flexibility

At times, small entities seek a tolerance or an exemption from the
requirement of a tolerance for pesticide residues resulting from
registered uses.  These actions are usually initiated for minor crop
uses for which the pesticide registrant is unwilling to seek a tolerance
or for residues on commodities which are not grown in the United States
and therefore for which there is no U.S. registrant, such as import
tolerances.  In such cases, the EPA can reduce the burden and cost to
small entities by adjusting the range of data requirements to be
commensurate with the extent of pesticide use.  The Agency also uses
this type of regulatory flexibility to set tolerances for residues on
commodities which are not grown in the United States.

5(d).	Collection Schedule

Not applicable.  This is not a scheduled collection.  A petition is
required only once for each raw or processed commodity on which the
pesticide is used.

6.	Estimating the Burden and Cost of the Collection

6(a).   Estimating Respondent Burden

 	Since 1995, the Agency has allowed for the use of a single petition to
request a tolerance action(s) for a group of similar crops, or "Crop
Groupings," rather than submitting individual petitions on a crop by
crop basis.  In reviewing some of the petitions, it is apparent that
many petitioners take advantage of this flexibility, including in the
petition requests for several tolerance actions.  Some have sought as
many as 15 crops per petition, including crop groupings.  FQPA
amendments allow anyone to submit a petition, where previously only
registrants could submit the petition.

Section 408 of FFDCA requires petitioners submit an information summary
of the petition and of the data, information and arguments submitted or
cited in support of the petition. FQPA requires EPA to consider
additional information in order to make the necessary regulatory
decisions.  EPA encouraged petitioners who previously submitted data
prior to enactment of the law to supplement their original submissions
with additional information to aid the Agency’s decision-making
process in light of its new statutory mandates.  To allow for the most
efficient processing and review of tolerance petitions, the Agency
provided a description of the types of information that EPA considers
helpful in the appendices to Pesticide Registration (PR) Notice No.
97-1.  

EPA continues to encourage petitioners to develop new and/or submit any
existing supplemental information with their petitions to help EPA
determine whether there is a reasonable certainty that no harm will
result from aggregate exposure.  EPA uses the data to make decisions
about the tolerance petitions.  The Agency’s risk managers review,
among other things, the regulatory aspects of each petition and
coordinate scientific review of the supporting data.  Agency residue
chemists and toxicologists review all the applicable data.   

Two types of respondent burden are considered in this analysis:
administrative burden and technical burden.  The respondents’
administrative burden is defined as the time spent to prepare and submit
a petition to the Agency.  This burden includes the time spent working
with the Agency throughout the petition process, gathering data and
supplemental information (such as safety reports, residue test data,
residue removal data), drafting the grounds for the petition, reviewing
and submitting the petition.  Technical burden includes the labor needed
to actually derive the test data which involves designing the test,
performing it, compiling test data and summarizing the results.  Only
burden related to the documentation of the test results, complying with
good laboratory standards in conducting the tests, and storing testing
information in files are included in the technical burden estimates for
this ICR.

	The Agency’s estimate of registrant burden was largely developed for
the previous Tolerance Petition ICR, using information from the
regulated community, and underwent several rounds of public scrutiny. 
The information was supplemented with additional feedback from IR-4 and
pesticide registrants.  The estimate also draws from the expertise of
the Agency’s lead divisions for the tolerance petition review process
(AD, BPPD, and RD), and their understanding of changing programmatic
requirements that may affect registrant burden.  The Agency will
consider information received through public comment to further refine
estimates of registrant burden.

6(b) Estimating Respondent Cost

Consistent with recent ICR renewals, OPP has used labor cost estimates
from Agency

economists with respect to wages, benefits and overhead for all labor
categories for affected industries, state government, and EPA employees.
The goal is to continue to use a transparent, consistent methodology and
current, publicly-available data, to provide more accurate estimates and
allow easy replication of the estimates.

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).
Fully loaded wage rates are used to calculate respondent costs. This
renewal uses 2007 base data.

Unloaded Wage Rate: Wages are estimated for labor types (management,
technical, and

clerical) within applicable sectors. The Agency uses average wage data
for the relevant sectors available in the National Industry-Specific
Occupational Employment and Wage Estimates from the Bureau of Labor
Statistics (BLS) at http://www.bls.gov/oes/current/oes_nat.htm.

Sectors: The specific North American Industry Classification System
(NAICS) code and

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

Loaded Wage Rate: Unless stated otherwise, all benefits represent 43% of
unloaded wage

rates, based on benefits for all civilian non-farm workers, from
ttp://www.bls.gov/news.release/ecec.t01.htm. However, if other sectors
are listed for which 43% is not applicable; the applicable percentage
will be stated.

Fully Loaded Wage Rate: We multiply the loaded wage rate by 50% (EPA
guidelines 20-

70%) to get overhead costs. A copy of the formula work sheets used to
re-estimate the labor rates and to derive the fully loaded rates and
overhead costs for this all of the respondents (registrants) and the
Agency for this ICR renewal are listed in Attachment H.

	The current ICR renewal estimates that an average of 103 tolerance
petitions will be submitted to the Agency each year for the next three
years.  This estimate is based on the average number of tolerance
petitions received by the Agency in the past three years (2006, 2007,
and 2008), and is a change from the estimate of the previous ICR of 150
tolerance petitions.  The Agency estimates that the average paperwork
burden associated with the submission of a single tolerance petition is
1,739 hours. This is an increase of 13 hours over the previous ICR for
tolerance petitions due to PRIA requirements.   Assuming that the Agency
will receive an average of 103 tolerance petitions each year for the
next 3 years, the Agency estimates that the overall annual paperwork
burden will be 179,117 hours.  This estimate is approximately 80
thousand hours less than the previous estimate, resulting from a
reduction in the estimated number of tolerance petitions that the Agency
anticipates receiving in the next three years.

Table 1. ANNUAL RESPONDENT BURDEN/COST ESTIMATES

ACTIVITIES	HOURS and RATES	COSTS 

(per petition)

	Mgmt. $138/hr	Tech. $73/hr	Cler.

$42/hr	Total Hours	

Total Costs

Review FFDCA regulations CFR citation; PRN 97-1	25	48	24	97	$7,962 

Conduct Field Trial 	252	1,080	25	1,357	$114,666 

Prepare Petition	55	30	116	201	$14,652 

Read Notice of any petition deficiency	1	1	1	3	$253 

Prepare response 	2	44	12	58	$3,992 

Maintain information	1	8	14	23	$1,310 

TOTAL BURDEN	336	1,211	192	1,739	$142,835 

Data Source:  U.S. Department of Labor, Bureau of Labor Statistics, May,
2007. (See cost worksheet Attachment H).

 	The overall annual cost associated with this information collection,
based on an estimate of 103 petitions per year, is estimated to be
$14,712,005.  For respondents, the value of labor per hour for
management, technical, and clerical is $138, $73, and $42, respectively.
 Labor rates are by occupation for the Research and Development in the
Physical, Engineering, and Life Sciences industry and are taken from the
U.S. Department of Labor, Bureau of Labor Statistics.  Labor rates are
fully loaded and include benefits and overhead costs applied using
procedures outlined in the Agency’s 2002 publication “EPA Air
Pollution Control Cost Manual”.  Using the Agency’s burden estimate
and fully-loaded labor rates, the Agency estimates the applicant costs
to be approximately $142,835 per response. 	

ANNUAL COSTS:

Management:	336 hours * $138 per hour * 103 tolerance petitions =
$4,775,904

Technical:	1,211 hours * $73 per hour * 103 tolerance petitions =
$9,105,509

Clerical:	192 hours * $42 per hour * 103 tolerance petitions =	$830,592

	TOTAL :	$14,712,005

These labor burden estimates represent average time and costs.  Some
tolerance petitions will require less effort and more complicated
petitions will require more.  The analysis assumes that one respondent
will generate the data for a given petition.  If a consortium takes
responsibility for the petition, the burden and cost will be distributed
across members of the consortium. 

6(c) Estimating Agency Burden and Cost

The Pesticide Registration Improvement Renewal Act (PRIA 2), which
became effective on October 1, 2007, requires the program to streamline
and create service fees for registration actions (see Attachment I).
This statute creates a more predictable evaluation process for affected
pesticide decisions, and couples the collection of individual fees with
specific decision review periods. PRIA 2 also promotes shorter decision
review periods for different types of pesticide applications.  PRA
burden hour and cost estimates for the PRIA program have been OMB
approved under the Pesticide Registration Fee Waivers ICR, 2070-0167;
EPA No# 2147.02 and are not included in the estimates for this ICR.  The
program reconfigured internal organizations to meet these new
challenges, which has reduced the PRA burden hours and costs for the
registrants, and increased PRA burden hours and costs on the Agency
under this ICR.

For this ICR renewal, the Agency is using data on internal OPP Divisions
that provide significant support and analysis for the FIFRA tolerance
petition 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 (see Attachment J) 
In the past, the Agency burden calculations for this ICR reflected only
activities for the tolerance petition ICR lead divisions (the
Registration Division (RD), the Biopesticides and Pollution Prevention
Division (BPPD), and the Antimicrobial Division (AD)).  The 2009 renewal
has added the appropriate FTE activity data from the Health and Effects
Division (HED), the Biological and Economic Analysis Division (BEAD),
Special Review and Re-registration Division (SRRD), Field and External
Affairs Division (FEAD) and the Environmental Fate and Effects Division
(EFED).  This approach reflects that (8) OPP Divisions work together to
complete the activities related to OPP tolerance petition reviews.  The
Agency believes that using data from the TAIS reflects the changes to
the internal operations for implementing and administering tolerance
petition 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 2003 (PRIA) as
reauthorized.

Using this new source of data the estimated number of Agency FTE’s
dedicated to tolerance petition activities is approximately 3 managerial
FTEs as shown in Table 2, 19 technical FTEs as shown in Table 3, and 2
clerical FTEs as shown in Table 4.  The aggregated Agency estimated FTE
dedicated to tolerance petition activities is 24 and the burden hours
are 49,920, assuming 2,080 hours per FTE.  

Table 2 – Distribution of Agency Managerial FTEs Supporting Tolerance
Petition Activities3  

AD	BEAD	BPPD	EFED	FEAD	HED	RD	SRRD

<1	<1	<1	<1	<1	<1	1.1	<1

Agency total 	3

Annual Agency burden hours were calculated using the number of hours per
FTE multiplied by the number of FTE’s (2080 * 3 = 6,240).

Table 3 – Distribution of Agency Technical FTEs Supporting Tolerance
Petition Activities 

AD	BEAD	BPPD	EFED	FEAD	HED	RD	SRRD

<1	1.2	<1	2.5	<1	3.8	9.6	<1

Agency total 	19

Annual Agency burden hours were calculated using the number of hours per
FTE multiplied by the number of FTE’s (2080 *19 = 39,520).

Table 4 – Distribution of Agency Clerical FTEs Supporting FIFRA
Tolerance Petition Activities3     

AD	BEAD	BPPD	EFED	FEAD	HED	RD	SRRD

<1	<1	<1	<1	<1	<1	<1	<1

Agency total 	2

Annual Agency burden hours were calculated using the number of hours per
FTE multiplied by the number of FTE’s (2080 * 2 = 4,160).

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 2007 dollars.  The fully loaded hourly mean wage
rate estimate for managerial occupations is $103 for an average annual
FTE cost of $214,240 ($103 per hour * 2,080 hours).  For technical
occupations, the fully loaded mean wage rate is $71 for an average
annual FTE cost of $147,680.  And for clerical occupations, the fully
loaded mean wage rate is $41 for an average annual FTE cost of $85,280.
(See Worksheet for NAICS 999100 EPA or Federal Government, Attachment K)

To calculate the Agency’s estimated annual cost of tolerance petition
activities, the number of FTEs allocated to tolerance petition
activities is multiplied by the cost per FTE.  This represents the
Agency’s estimate of its cost that will result from tolerance petition
activities for each of the next three years. Annual estimated management
costs are $642,720 (3 FTE * $214,240 per FTE); technical costs are
$2,805,920 (19 FTE * $147,680 per FTE); and clerical costs are $170,560
(2 FTE * $85,280 per FTE).  Total estimated Agency cost is $3,619,200.

	6(d) Bottom Line Burden Hours and Cost

 

Table 5 - Burden Hour and Cost Summary

	Burden Hours	Cost

Registrant Burden	179,117	$14,712,005

Agency Burden	49,920	$3,619,200

6(e) Reason for Changes in Burden

Agency 

The EPA has significantly lowered processing hours to about two-thirds
of the previous ICR due to changes in the anticipated number of
tolerance petitions in the next three years.  The Agency is also using a
new source of data consistent with its time reporting to calculate
burden.  According to this data source, processing tolerance petitions
requires significantly fewer hours than previously thought.  The
decrease in hours and costs reflects both internal program adjustments
and changes in the method used to calculate Agency burden.

Respondents

The average number of hours required to submit a tolerance petition has
not changed significantly from the last ICR.   Thirteen additional
managerial burden hours were added for each petition to the “prepare
petition” activity based on changes resulting from PRIA.  Labor rates
were also adjusted to reflect current information from the Bureau of
Labor Statistics, instead of updating data using an inflation index.

6(f) Burden Statement

The Agency has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2008-0927, which is available for online viewing at  
HYPERLINK "http://www.regulations.gov"  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 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-2008-0927 and OMB control number 2070-0024 in any
correspondence but do not submit information under this collection to
these addresses.

Attachments List

All of the attachments listed below can be found in the docket for this
ICR (unless otherwise noted); 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, EPA-HQ-OPP-2005-0291
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:	FFDCA Section 408 (21 U.S.C. Sections 346a).

21 USC 346a 	  HYPERLINK
"http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t21t25+14
9+1++%28%29%20%20AND%20%28%2821%29%20ADJ%20USC%29%3ACITE%20AND%20%28USC%
20w%2F10%20%28346a%29%29%3ACITE%20%20%20%20%20%20%20%20%20" 
http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t21t25+149
+1++%28%29%20%20AND%20%28%2821%29%20ADJ%20USC%29%3ACITE%20AND%20%28USC%2
0w%2F10%20%28346a%29%29%3ACITE%20%20%20%20%20%20%20%20%20  

ATTACHMENT B:  Accomplishments under the Food Quality Protection Act at 
                                           HYPERLINK
"http://www.epa.gov/pesticides/regulating/laws/fqpa/fqpa_accomplishments
.htm" 
http://www.epa.gov/pesticides/regulating/laws/fqpa/fqpa_accomplishments.
htm 

ATTACHMENT C:	40 CFR Parts 180.7 through 180.41 - Tolerances and
Exemptions from Tolerances for Pesticide Chemicals in or on Raw
Agricultural Commodities.   HYPERLINK
"http://edocket.access.gpo.gov/cfr_2002/julqtr/pdf/40cfr180.41.pdf" 
http://edocket.access.gpo.gov/cfr_2002/julqtr/pdf/40cfr180.41.pdf 

ATTACHMENT D:	PR Notice 97-1 - Agency Actions under the Requirements of
the Food Quality Protection Act. 

			  HYPERLINK "http://www.epa.gov/opppmsd1/PR_Notices/pr97-1.html" 
http://www.epa.gov/opppmsd1/PR_Notices/pr97-1.html  

ATTACHMENT E: 	List of Consultation Questions (Reserved)

ATTACHMENT F:	Electronic Submission Interim Guidance Documents  
HYPERLINK
"http://www.epa.gov/pesticides/regulating/registering/submissions/" 
http://www.epa.gov/pesticides/regulating/registering/submissions/  

ATTACHMENT G:	FIFRA Section 3 (7 U.S.C. 136a)

			  HYPERLINK
"http://agriculture.senate.gov/Legislation/Compilations/Fifra/FIFRA.pdf"
 http://agriculture.senate.gov/Legislation/Compilations/Fifra/FIFRA.pdf 

ATTACHMENT H:	Worksheets Used to Calculate Pesticide Registration
Industry Labor Costs

ATTACHMENT I:	PRIA 2 history at   HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/" 
http://www.epa.gov/pesticides/regulating/fees/ 

ATTACHMENT J:	Time and Attendance Information System (TAIS) Plan Program
Accomplishment (PPA) Codes Used to Calculate EPA and Federal Government
Burden Hours

ATTACHMENT K:	Worksheets Used to Calculate EPA and Federal Government
Labor Costs

     	PR Notice 97-1 applies to most applicants with registration
applications, non-crop-destruct experimental use permit applications,
and tolerance or tolerance exemption petitions pending within the
Agency.  It also applies to most future applicants seeking new or
amended pesticide registrations and all actions involving synthetic
chemicals, antimicrobial, biochemical and microbial pesticides.

     	The Agency burden related to OPP’s Information Technology and
Resource Management Division (ITRMD) processing activities are not
included in the burden estimate because ITRMD provides the preliminary
data processing and tracking for many OPP ICR activities including
tolerance petitions.  These systems are integrated for efficient
processing, tracking, and maintaining data but they do not readily lend
themselves to a clear burden breakdown by ICR activity.

     	The FTE burden in SRRD and FEAD for each labor category
(managerial, technical and clerical) amounted to significantly less than
1 FTE. The estimate for the Agency FTE for each labor category was
rounded up to account for the contribution of FEAD and SRRD to the
tolerance petition FTE burden.

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