Document ID: EPA-HQ-OPP-2015-0715-0014
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-12-24T05:00Z

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
Food Use Inert Ingredients 

EPA ICR No. 0597.12		 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 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.  

Applicants may petition the EPA for a variety of tolerance actions, the
timeframes of which are established by Congress. This ICR describes the
processes and burden hours associated with the establishment of new
tolerances for pesticides. These approaches can be used to establish
tolerances or the explicit exemption from the requirements of a
tolerance for a pesticide on raw and processed foods.  The vast majority
of these actions are taken in response to petitions from registrants
(pesticide manufacturers) for the establishment of new tolerances for an
existing pesticide ingredient.  The agency may also initiate tolerance
actions.

  Pesticide tolerances are needed in order to support the interstate
movement of pesticide-treated foods in commerce.  The Food and Drug
Administration (FDA) has lead responsibility in the U.S. for tolerance
enforcement.  Food 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 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 B).

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 filing 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 revoking 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 neurotoxicity, developmental, reproductive and cancer
health effects.  

The collection of information covered by this ICR is needed to ensure
that the statutory requirements related to tolerances can be met by
respondents 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
harmful 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.

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 C).  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.  The agency residue chemists and toxicologists review
all the applicable data and prepare a risk assessment necessary to
evaluate if the tolerance can be established.  As a result of these
reviews, EPA completes the statutory evaluation of the data and, based
on the assessment, concludes 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

There is no duplication of information because there are no EPA offices
or other government agencies that have the data necessary to evaluate
tolerance petitions.  The requirements for this ICR represent a unique
non-redundant information requirement.

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 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 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 ID number EPA-HQ-OPP-2015-0715.  

3(c).	Consultations

	Under 5 CFR 1320.8(d)(1), OMB requires agencies to consult with
potential ICR respondents and data users about specific aspects of ICRs
before submitting an original or renewal ICR to OMB for review and
approval.  

During the public comment period for this draft, EPA staff will contact
respondent representatives to seek feedback on the burden estimates in
the ICR and the clarity of guidance provided.  The responses to EPA’s
consultation efforts will be summarized and made publicly available with
the final ICR renewal request, which will be updated as appropriate to
take into account the results of consultation.

	

	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 Paperwork Reduction Act of 1995 (PRA) guideline
that records be retained for no more than three years.

As of September 1, 2015 registrants have a fully electronic submission
option called the Pesticide Submission Portal (the Portal). The Portal
uses a secure database to process tolerance petition requests. However,
registrants still have the option of using the previous submission
methods- by paper, CD, or DVD.  As this option is very new to the
agency, there is currently no data to evaluate it through this ICR.
During the next renewal cycle for this ICR we anticipate having burden
information for respondents to determine the effects of the Portal on
tolerance petition submissions. 

By offering this electronic submission option, the agency is keeping
with the Executive Order on "Reducing Reporting and Paperwork Burdens"
and other related policy and guidance.  The agency continues the process
of improving options for electronic submission of studies as well as
other elements of applications and petitions.  This includes efforts to
enhance information technology approaches to protect FIFRA Confidential
Business Information submitted over the Internet.  Please see,
“Assembly of Electronic Packages and Discs” (Attachment D).

Electronic submissions:  OMB 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)).  As discussed
previously, OPP now offers a fully electronic submission option.

 

In the past, registrants would be required to submit three paper copies
of study data to EPA; however, registrants now submit one paper copy if
they submit the required study data in Adobe Acrobat Portable Document
Format (PDF) on a compact disc. Extensive guidance regarding available
electronic submission option is available to registrants via the OPP
Internet site at
http://www2.epa.gov/pesticide-registration/electronic-submissions-pestic
ide-applications.

During the years covered in this ICR renewal, companies most often use
two methods for assembling the e-submission discs for
electronic-Submission (or "e-Submissions). In both methods, the files to
be submitted along with an XML data file containing information about
the files and the submission itself are “zipped” into a single file
and placed on a disc (CD/DVD) for submission to the EPA. The first is a
newer method introducing the use of a “builder” application. The
second, introduced in July 2008, requires the manual editing of the XML
file. The XML method of information exchange from industry to EPA is
based on a harmonized XML schema used by Canada's PMRA, which OPP has
adapted. This harmonization assures industry that a documentation
package submitted to one participating regulatory agency can also be
submitted to the other participating agency, increasing standardization
and decreasing the burden on industry. Additional information about both
e-submission methods can be accessed at:   HYPERLINK
"http://www2.epa.gov/pesticide-registration/assembly-electronic-packages
-and-discs" 
http://www2.epa.gov/pesticide-registration/assembly-electronic-packages-
and-discs .

EPA encourages electronic submissions for the following regulatory
actions:

New pesticide active ingredients.

New pesticide products containing already-registered pesticide active
ingredients.

Amendments to registered pesticide products.

Experimental use permits.

Petitions for food tolerance.

Distributor products.

Endocrine Disruptor Screening Program (EDSP) Orders.

Overall, EPA is investigating opportunities for technological
improvements which focus on information collection using fully
electronic tools. The ability to electronically submit information
required for registration reduces the burden of sending, receiving, and
archiving paper submissions, and eliminates the need for multiple data
entries across forms. One of OPP’s priority areas in developing such
electronic tools is related to electronic submission of data and
labels. Some of the tools under this initiative are the electronic
Confidential Statement of Product Specifications (CSPS) form (to be used
in lieu of the Confidential Statement of Formula or CSF) the SmartLabel,
and the now functional web-based portal.  

The development of the Portal is a critical step in the realization of
EPA’s long-term vision for secure data exchange between registrants
and the agency. Whereas registration applications typically require an
ink signature, the Portal uses EPA’s Central Data Exchange (CDX) to
allow applicants to electronically sign and securely submit the required
information. The use of CDX is expected to save registrants’ and the
agency’s time and resources by simplifying data submissions, receipt
confirmation, information access and reporting.

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. 
While any entity can file a petition with the agency, such petitions
typically come from those businesses engaged in the manufacturing of
pesticides and the Interregional Research Project No.4 (IR-4) (see
Attachment G).  Thus, the agency only calculates the burden for these
two groups.

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

 

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.

Management, Scientific, and Technical Consulting Services	541600
Establishments primarily engaged in administrative management and
general management consulting services.

4(b).  Information Requested in this Collection

(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 timing 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.  

(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 involves: 

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 exposure and risk assessments on requested tolerance, 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 a 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. Tolerances are PRIA actions with fees established by
Congress with the provision of fee waivers and fee exemptions in certain
circumstances. The EPA’s website is a resource for the public on fees
and the process for seeking a waiver or exemption of fees:   HYPERLINK
"http://www2.epa.gov/pria-fees/pria-fee-waivers-small-businesses" 
http://www2.epa.gov/pria-fees/pria-fee-waivers-small-businesses .

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

 	The current ICR renewal estimates that an average of 165 tolerance
petitions will be submitted to the Agency each year for the next three
years.  The Agency estimates that an average of 111 of the 165 tolerance
petitions will be submitted directly by registrants, and 26 will be
submitted by IR-4.  This estimate is based on the average number of
tolerance petitions received by the Agency in the past three years
(2012, 2013, and 2014), and is an increase from the estimate in the
previous ICR of 103 tolerance petitions.  

	The Agency estimates that the average paperwork burden associated with
the submission of a single tolerance petition is 1,726 hours for
petitioners and 1,739 hours for those submitted through IR-4. The
additional 13 hours required to process each IR-4 petition is due to a
fee waiver incentive to submit label amendments with the registration
package and the tolerance petitions.  The Pesticide Registration
Improvement Act (PRIA) of 2003, last renewed under PRIA 3, established
registration service fees for pesticide registration actions.  (See
Attachments G and H.) On March 6, 2008, the President signed a technical
correction to PRIA to exempt fees for certain registration applications
associated with IR-4 tolerance petitions.  This correction became
effective retroactively on October 1, 2007.  To qualify for the IR-4
provisions for this fee exemption, EPA requires that the registration
application is solely associated with a tolerance petition submitted in
connection with IR-4, and the action must be considered to be in the
public interest.  A document that describes the process is attached and
more information can be accessed at the following link:   HYPERLINK
"http://www2.epa.gov/pria-fees/guidance-ir-4-exemptions" 
http://www2.epa.gov/pria-fees/guidance-ir-4-exemptions .  In addition,
under PRIA 3, the agency must determine that the exemption is in the
public interest. In February 2013, the agency issued the policy document
entitled “Factors for IR-4 Public Interest Finding” (Attachment K)
which lists the criteria under which an application will be presumed to
be in the public interest.  

	Assuming that the Agency will receive an average of 165 tolerance
petitions each year for the next 3 years, the Agency estimates that the
overall annual paperwork burden for all petitioners will be 285,128
hours.  This estimate is 48,328 hours more than the previous estimate,
resulting from an increase in the estimated number of tolerance
petitions that the Agency anticipates receiving in the next three years.

	

	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 provided a description of the types of
information that EPA considers helpful in the appendices to Pesticide
Registration (PR) Notice No. 97-1.  

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 petitioner burden was largely developed from
the previous Tolerance Petition ICR, using information from the
regulated community. The information was supplemented with additional
feedback from IR-4 and other tolerance petitioners.  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
tolerance petitioners’ burden.  The Agency will consider information
received through public comment to further refine estimates of
petitioner 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. 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 2015 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 46.3%
of unloaded wage rates, based on benefits for all civilian non-farm
workers, from http://www.bls.gov/news.release/ecec.t01.htm. However, if
other sectors are listed for which 46.3% 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 all respondents (registrants and
IR-4) and the Agency for this ICR renewal are listed in Attachments I,
J, and K respectively.

Table 1. PETITIONER BURDEN/COST ESTIMATES PER RESPONSE

ACTIVITIES	HOURS and RATES	COSTS 

(per petition)

	Mgmt. $167.90/hr	Tech. $87.34/hr	Cler.

$49.90/hr	Total Hours	

Total Costs

Review FFDCA regulations CFR citation; PRN 97-1	25	48	24	97	$9,587 

Conduct Field Trial 	252	1,080	25	1,357	$137,886 

Prepare Petition	42	30	116	188	$15,460 

Read Notice of any petition deficiency	1	1	1	3	$305 

Prepare response 	2	44	12	58	$4,778 

Maintain information	1	8	14	23	$1,565 

TOTAL BURDEN	323	1,211	192	1,726	$169,581.24 

Data Source:  U.S. Department of Labor, Bureau of Labor Statistics, May,
2014. (See cost worksheet Attachment F).

Table 2. IR-4 BURDEN/COST ESTIMATES PER PETITION PER RESPONSE

ACTIVITIES	HOURS and RATES	COSTS 

(per petition)

	Mgmt. $150.08/hr	Tech. $75.75/hr	Cler.

$41.52/hr	Total Hours	

Total Costs

Review FFDCA regulations CFR citation; PRN 97-1	25	48	24	97	$8,384 

Conduct Field Trial 	252	1,080	25	1,357	$120,668 

Prepare Petition	55	30	116	201	$15,343 

Read Notice of any petition deficiency	1	1	1	3	$267 

Prepare response 	2	44	12	58	$4,131 

Maintain information	1	8	14	23	$1,337 

TOTAL BURDEN	336	1,211	192	1,739	$150,131.97 

Data Source:  U.S. Department of Labor, Bureau of Labor Statistics, May,
2014. (See cost worksheet Attachment G).

	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”.  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. 
Data is from the U.S. Department of Labor, Bureau of Labor Statistics.  

	For tolerance petitioners, the value of labor per hour for management,
technical, and clerical is $167.90, $87.34 and $49.90 respectively. 
Labor rates are by occupation for the Research and Development in the
Physical, Engineering, and Life Sciences industry (NAICS 541710).  Using
the Agency’s burden estimate and fully-loaded labor rates, the Agency
estimates petitioner costs to be approximately $169,581 per response. 
The overall annual cost to petitioners associated with this information
collection, based on an estimate of 139 petitions per year, is estimated
to be $23,571,792.36.  

	For IR-4, the value of labor per hour for management, technical, and
clerical is $150.08, $75.75, and $41.52, respectively.  Labor rates are
by occupation for Management, Scientific, and Technical Consulting
Services industry (NAICS 541600).  Using the Agency’s burden estimate
and fully-loaded labor rates, the Agency estimates IR-4 costs to be
approximately $150,131.97 per response.  The overall annual cost to
petitioners associated with this information collection, based on an
estimate of 26 petitions per year, is estimated to be $3,903,431.22.  

	The overall annual cost to respondents associated with this information
collection, including petitioners and IR-4, based on an average total
estimate of 165 petitions per year, is estimated to be $27,475,223.58.  

ANNUAL COSTS:

Industry

Management:	323 hours * $167.90 per hour * 139 tolerance petitions =
$7,538,206.30

Technical:	1,211 hours * $87.34 per hour * 139 tolerance petitions =
$14,701,854.86

Clerical:	192 hours * $49.90 per hour * 139 tolerance petitions =
$1,331,731.20

	Industry TOTAL:	$23,571,792.36

IR-4

Management:	336 hours * $150.08 per hour * 26 tolerance petitions =
$1,311,098.88

Technical:	1,211 hours * $75.75 per hour * 26 tolerance petitions =
$2,385,064.50

Clerical:	192 hours * $41.52 per hour * 26 tolerance petitions =
$207,267.84

	IR-4 TOTAL:	$3,903,431.22

	GRAND TOTAL:	$27,475,223.58

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 Extension Act (PRIA 3), which
became effective on October 1, 2012, reauthorized the Pesticide
Registration Improvement Renewal Act of 2007 (PRIA 2) for five more
years, until 2017. Both Acts established pesticide registration service
fees for registration actions. The category of action, the amount of the
pesticide registration service fee, and the corresponding decision
review periods by year are prescribed in these statutes. Their goal is
to create a more predictable evaluation process for affected pesticide
decisions, and couple the collection of individual fees with specific
decision review periods. They also promote shorter decision review
periods for reduced-risk applications.

PRA burden hour and cost estimates for the PRIA program have been OMB
approved under the Pesticide Registration Fees Program ICR (OMB Control
No. 2070-0179; EPA No. 2330) and are not included in the estimates for
this ICR.  This ICR only applies to the information collection
activities associated with the submission of a petition for a tolerance
action.  The program reconfigured internal organizations to meet the
challenges under PRIA 2 and 3, which has reduced the PRA burden hours
and costs for the petitioners, 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 FFDCA 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).
The Agency burden calculations reflect activities for the tolerance
petition ICR lead divisions (the Registration Division (RD), the
Biopesticides and Pollution Prevention Division (BPPD), and the
Antimicrobial Division (AD)), as well as the appropriate FTE activity
data from the Health and Effects Division (HED), the Biological and
Economic Analysis Division (BEAD), Pesticide Re-evaluation Division
(PRD), 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 internal operations for implementing and
administering tolerance petition activities.

Using TAIS, the estimated number of Agency FTE’s dedicated to
tolerance petition activities is approximately 1.572 managerial FTEs as
shown in Table 2, 14.256 technical FTEs as shown in Table 3, and 0.432
clerical FTEs as shown in Table 4.  The aggregated Agency estimated FTE
dedicated to tolerance petition activities is 16.26. The associated
Agency burden hours are 33,820.80, assuming 2,080 hours per FTE.  

Table 3 – Distribution of Agency Managerial FTEs Supporting Tolerance
Petition Activities3  

AD	BEAD	BPPD	EFED	FEAD	HED	RD	PRD

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

Agency total 	1.572

Annual Agency burden hours were calculated using the number of hours per
FTE multiplied by the number of FTE’s (2080 * 1.572 = 3,269.76).

Table 4 – Distribution of Agency Technical FTEs Supporting Tolerance
Petition Activities 

AD	BEAD	BPPD	EFED	FEAD	HED	RD	PRD

<1	<1	<1	<1	<1	3.444	9.552	<1

Agency total 	14.256

Annual Agency burden hours were calculated using the number of hours per
FTE multiplied by the number of FTE’s (2080 *14.256 = 29,652.48).

Table 5 – Distribution of Agency Clerical FTEs Supporting FIFRA
Tolerance Petition Activities3     

AD	BEAD	BPPD	EFED	FEAD	HED	RD	PRD

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

Agency total 	0.432

Annual Agency burden hours were calculated using the number of hours per
FTE multiplied by the number of FTE’s (2080 * 0.432 = 898).

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 2014 dollars.  The fully loaded hourly mean wage
rate estimate for managerial occupations is $124.09 for an average
annual FTE cost of $258,107.20 ($124.09 per hour * 2,080 hours).  For
technical occupations, the fully loaded mean wage rate is $81.53 for an
average annual FTE cost of $169,582.40 ($81.53* 2,080).  For clerical
occupations, the fully loaded mean wage rate is $46.42 for an average
annual FTE cost of $96.553.60 ($46.42* 2,080). (See Worksheet for NAICS
999100 EPA or Federal Government, Attachment H.)

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 $405,744.52 (1.572 FTE * $258,107.20 per FTE); technical costs
are $2,417,566.69 (14.256 FTE * $169,582.40 per FTE); and clerical costs
are $41,702.52 (0.432 FTE * $96,533.60 per FTE).  Total estimated Agency
cost is $2,919,844.81. 

	6(d) Bottom Line Burden Hours and Cost

 

Table 6 - Burden Hour and Cost Summary

	Burden Hours	Cost

Petitioner Burden	285,128	$27,475,223.58

Agency Burden	33,820	$2,919,844.81

6(e) Reason for Changes in Burden

Agency 

The agency estimates that an average of 165 tolerance petitions will be
received annually.  This is an average increase of 28 tolerance
petitions annually.  The estimate is based on the average number of
tolerance petitions received by the Agency in the years FY2012, FY2013,
and FY2014. 

Petitioners (Respondents)

EPA estimates a net increase of 48,328 burden hours annually over the
expiring ICR. This increase is a result of an increase from 137 to 165
in the estimated average number of tolerance petitions submitted
annually, which resulted in a change to the annual burden hours for
respondents from 236,800 in the previous renewal to 285,128 in the
current renewal.  There is no change in burden per tolerance petition;
burden for respondents increased as a result of the estimated increase
in the average number of petitions submitted annually. The change is an
adjustment. 

6(f) Burden Statement

 The annual respondent burden for collection of information associated
with tolerance petitions is estimated to average 1,726 hours for
petitions submitted by industry and 1,739 for petitions submitted by
IR-4 participants.  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.  This includes the
time needed to review instructions; develop, acquire, install, and
utilize technology and systems for the purposes of collecting,
validating, and verifying information, processing and maintaining
information, and disclosing and providing information; adjust the
existing ways to comply with any previously applicable instructions and
requirements which have subsequently changed; train personnel to be able
to respond to a collection of information; search data sources; complete
and review the collection of information; and transmit or otherwise
disclose the information.  

The Agency has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2015-0715, which is available for online viewing at
http://www.regulations.gov or in person viewing at the EPA Docket
Center-Public Reading Room, EPA West Building, in Rm. S-3334, 1301
Constitution Avenue, NW, Washington, DC. This docket facility is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding federal
holidays.  The docket telephone number is (202) 566-1744.  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.  Include Docket ID No.
EPA-HQ-OPP-2015-0715 and OMB control number 2070-0024 in any
correspondence but do not submit information under this collection to
these addresses.

Attachments List: Supporting Statement (EPA-HQ-OPP-2015-0715)

All of the attachments listed below can be found in the docket for this
ICR (unless otherwise noted); accessible electronically through http:// 
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-2015-0715
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.

ATTACHMENT A:	FFDCA Section 408 (21 U.S.C. Sections 346a)

  HYPERLINK
"http://www.gpo.gov/fdsys/pkg/USCODE-2008-title21/pdf/USCODE-2008-title2
1-chap9-subchapIV-sec346.pdf" 
http://www.gpo.gov/fdsys/pkg/USCODE-2008-title21/pdf/USCODE-2008-title21
-chap9-subchapIV-sec346.pdf 

ATTACHMENT B:	40 CFR Part 180 - Tolerances and Exemptions from
Tolerances for Pesticide Chemicals in Food

  HYPERLINK
"http://www.access.gpo.gov/nara/cfr/waisidx_04/40cfr180_04.html" 
http://www.access.gpo.gov/nara/cfr/waisidx_04/40cfr180_04.html  

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

  HYPERLINK
"http://www2.epa.gov/pesticide-registration/prn-97-1-agency-actions-unde
r-requirements-food-quality-protection-act" 
http://www2.epa.gov/pesticide-registration/prn-97-1-agency-actions-under
-requirements-food-quality-protection-act 

ATTACHMENT D:	Assembly of Electronic Packages and Discs

			  HYPERLINK
"http://www2.epa.gov/pesticide-registration/assembly-electronic-packages
-and-discs" 
http://www2.epa.gov/pesticide-registration/assembly-electronic-packages-
and-discs 

ATTACHMENT E:	Registration Service Fees Guidance on IR-4 Exemptions

			  HYPERLINK "http://www2.epa.gov/pria-fees/guidance-ir-4-exemptions" 
http://www2.epa.gov/pria-fees/guidance-ir-4-exemptions .   

ATTACHMENT F:	Worksheets Used to Calculate Pesticide Industry (Tolerance
Petitioner) Labor Costs

ATTACHMENT G:	Work Sheets used to Calculate IR-4 Labor Costs  

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

ATTACHMENT I: 	Pesticide Registration Improvement Extension Act (PRIA 3)
of 2012

  HYPERLINK
"http://www2.epa.gov/pria-fees/fy-201617-fee-schedule-registration-appli
cations" 
http://www2.epa.gov/pria-fees/fy-201617-fee-schedule-registration-applic
ations 

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

ATTACHMENT K:	Factors for IR-4 Public Interest Finding

			  HYPERLINK
"http://www2.epa.gov/pria-fees/factors-ir-4-public-interest-finding" 
http://www2.epa.gov/pria-fees/factors-ir-4-public-interest-finding 

ATTACHMENT L:	Setting Tolerances for Pesticide Residues in Food 

  HYPERLINK
"http://www2.epa.gov/pesticide-tolerances/setting-tolerances-pesticide-r
esidues-foods" 
http://www2.epa.gov/pesticide-tolerances/setting-tolerances-pesticide-re
sidues-foods 

			

ATTACHMENT M:	Reserve for Display Related to OMB Control Numbers

     	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.

 IR-4 industry classification based on National Economic Impact, Center
for Economic Analysis

Michigan State University, May 25, 2007,   HYPERLINK
"http://ir4.rutgers.edu/Other/IR4EconomicImpact.pdf" 
http://ir4.rutgers.edu/Other/IR4EconomicImpact.pdf .

     	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.

December 2, 2015

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