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. 0597.11		 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 tolerance petitioners 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 is publishing a Federal Register (FR)
Notice announcing the renewal of this information collection activity
and providing a 60-day public comment period.

3(c).	Consultations

	Under 5 CFR 1320.8(d)(1), agencies are required 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 development of this renewal ICR, EPA staff will
contact appropriate stakeholders and ask them for their assessment of
the regulatory burden estimates expressed by the Agency in this ICR.  A
summary of these consultations will be provided as part of the
supporting statement during the second comment period.

	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)).  Petitioners 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. The Agency is actively working to extend full
electronic submission options in keeping with the recent Executive Order
on "Reducing Reporting and Paperwork Burdens" and other related policy
and guidance.  In the future, the Agency hopes to be able to offer a
fully electronic submission option. The Agency 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.
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

(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 H).

(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

*If review is conducted by IR-4, label amendments and PRIA incentives
review is conducted

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 petitioner 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

 	The current ICR renewal estimates that an average of 137 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 137 tolerance
petitions will be submitted directly by petitioners, 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
(2009, 2010, and 2011), and is an increase from the estimate in the
previous ICR of 34 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 renewed under
PRIA 2, established registration service fees for pesticide registration
actions.  (See Attachments I and J.)  On March 6, 2008, the President
signed a technical correction to PRIA 2 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 tolerance petitions be submitted solely in connection with the
registration package, and must include a label amendment request
indicating the new use(s), application rates, as well as any
precautionary and advisory statements under the proposed tolerance.
Thus, IR-4 is conducting more preliminary reviews for the label
amendments, which has resulted in a slightly increased burden when
compared with the other petitioners. (See Attachment K.)

	Assuming that the Agency will receive an average of 137 tolerance
petitions each year for the next 3 years, the Agency estimates that the
overall annual paperwork burden for all petitioners will be 236,800
hours.  This estimate is 58,515 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.

	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.  FQPA amendments also allow anyone to submit a petition,
where previously only registrants could submit the petition.  Currently,
the Agency does not have tracking mechanisms in place to disaggregate
petitions submitted as crop groupings from those submitted as individual
crops or to disaggregate the various groups of petitioners.   However, a
very informal review of some of the petitions seems to indicate
petitioners are taking advantage of at least the crop grouping
flexibility where some have sought as many as 15 crops per 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 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 2011 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  http://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 all respondents (tolerance
petitioners and petitioners who submit through IR-4) and the Agency for
this ICR renewal are listed in AttachmentsL, M, and N respectively.

Table 1. PETITIONER BURDEN/COST ESTIMATES

ACTIVITIES	HOURS and RATES	COSTS

(per petition)

	Mgmt. $156/hr	Tech. $81/hr	Cler.

$46/hr	Total Hours

Total Costs

Review FFDCA regulations CFR citation; PRN 97-1	25	48	24	97	$8,892

Conduct Field Trial 	252	1,080	25	1,357	$127,942

Prepare Petition	42	30	116	188	$14,318

Read Notice of any petition deficiency	1	1	1	3	$283

Prepare response 	2	44	12	58	$4,428

Maintain information	1	8	14	23	$1,448

TOTAL BURDEN	323	1,211	192	1,726	$157,311

Data Source:  U.S. Department of Labor, Bureau of Labor Statistics, May,
2011. (See cost worksheet Attachment L).

Table 1. IR-4 BURDEN/COST ESTIMATES PER PETITION

ACTIVITIES	HOURS and RATES	COSTS

(per petition)

	Mgmt. $141/hr	Tech. $76/hr	Cler.

$39/hr	Total Hours

Total Costs

Review FFDCA regulations CFR citation; PRN 97-1	25	48	24	97	$8,109

Conduct Field Trial 	252	1,080	25	1,357	$118,587

Prepare Petition	55	30	116	201	$14,559

Read Notice of any petition deficiency	1	1	1	3	$256

Prepare response 	2	44	12	58	$4,094

Maintain information	1	8	14	23	$1,295

TOTAL BURDEN	336	1,211	192	1,739	$146,900

Data Source:  U.S. Department of Labor, Bureau of Labor Statistics, May,
2011. (See cost worksheet Attachment M).

	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 $156, $81 and $46 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 $157,311 per response.
The overall annual cost to petitioners associated with this information
collection, based on an estimate of 111 petitions per year, is estimated
to be $17,461,521.

	For IR-4, the value of labor per hour for management, technical, and
clerical is $141, $76, and $39, 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 $146,900 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 $3,819,400.

	The overall annual cost to respondents associated with this information
collection, including petitioners and IR-4, based on an average total
estimate of 137 petitions per year, is estimated to be $21,280,921.

ANNUAL COSTS:

Industry

Management:	323 hours * $156 per hour * 111 tolerance petitions =
$5,593,068

Technical:	1,211 hours * $81 per hour * 111 tolerance petitions =
$10,888,101

Clerical:	192 hours * $46 per hour * 111 tolerance petitions =	$980,352

	Industry TOTAL:	$17,461,521

IR-4

Management:	336 hours * $141 per hour * 26 tolerance petitions =
$1,231,776

Technical:	1,211 hours * $76 per hour * 26 tolerance petitions =
$2,392,936

Clerical:	192 hours * $39 per hour * 26 tolerance petitions =	$194,688

	IR-4 TOTAL:	$3,819,400

	GRAND TOTAL:	$21,280,921

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 O).
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 (OMB Control
No. 2070-0167; EPA No. 2147) 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
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 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 P).
TheAgency 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), 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 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 1.31 managerial FTEs as
shown in Table 2, 11.88 technical FTEs as shown in Table 3, and 0.36
clerical FTEs as shown in Table 4.  The aggregated Agency estimated FTE
dedicated to tolerance petition activities is 14. The associated Agency
burden hours are 28,172, 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

Agency total 	1.31

Annual Agency burden hours were calculated using the number of hours per
FTE multiplied by the number of FTE’s (2080 * 1.31 = 2,725).

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

AD	BEAD	BPPD	EFED	FEAD	HED	RD	SRRD

<1	<1	<1	<1	<1	2.87	7.96	<1

Agency total 	11.88

Annual Agency burden hours were calculated using the number of hours per
FTE multiplied by the number of FTE’s (2080 *11.88 = 24,711).

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 	0.36

Annual Agency burden hours were calculated using the number of hours per
FTE multiplied by the number of FTE’s (2080 * 0.36 = 748).

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 2011 dollars.  The fully loaded hourly mean wage
rate estimate for managerial occupations is $120 for an average annual
FTE cost of $249,600 ($120 per hour * 2,080 hours).  For technical
occupations, the fully loaded mean wage rate is $78 for an average
annual FTE cost of $162,240 ($78* 2,080).  For clerical occupations, the
fully loaded mean wage rate is $44 for an average annual FTE cost of
$91,520 ($44* 2,080). (See Worksheet for NAICS 999100 EPA or Federal
Government, Attachment N.)

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 $326,976 (1.31 FTE * $249,600 per FTE); technical costs are
$1,927,411 (11.88 FTE * $162,240 per FTE); and clerical costs are
$32,947 (0.36 FTE * $91,520 per FTE).  Total estimated Agency cost is
$2,287,334.

	6(d) Bottom Line Burden Hours and Cost

Table 5 - Burden Hour and Cost Summary

	Burden Hours	Cost

Petitioner Burden	236,800	$21,280,921

Agency Burden	28,184	$2,287,334

6(e) Reason for Changes in Burden

Agency

The EPA has lowered processing hours by approximately 40% compared to
the previous ICR due to increased efficiency in petition processing over
the last three years.  The Agency estimates that an average of 137
tolerance petitions will be received annually.  This is an increase of
34 tolerance petitions annually.  The estimate is based on the average
number of tolerance petitions received by the Agency in the years
FY2009, FY2010, and FY2011. The decrease in hours and costs reflects
internal program adjustments.

Petitioners (Respondents)

EPA estimates a net increase of 58,515 burden hours annually over the
expiring ICR. This increase is a result of an increase from 103 to 137
in the estimated average number of tolerance petitions submitted
annually, which resulted in a change to the annual burden hours for
respondents from 178,285 in the previous renewal to 236,800 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-2012-0744, which is available for online viewing at
HYPERLINK "http://www.regulations.gov"  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-2012-0744 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-2012-0744)

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-2012-0744
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://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

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

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

ATTACHMENT E: 	Public Comment (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:	7 USC 450i: Competitive, special, and facilities research
grants

			  HYPERLINK
"http://www.csrees.usda.gov/funding/nri/nri_7usc450i.html"
http://www.csrees.usda.gov/funding/nri/nri_7usc450i.html

ATTACHMENT H:	FIFRA Section 3 (7 U.S.C. 136a) (see page 16):

http://www.epa.gov/pesticides/bluebook/FIFRA.pdf

7 U.S.C. 136a:

  HYPERLINK
"http://www.gpo.gov/fdsys/pkg/USCODE-2011-title7/pdf/USCODE-2011-title7-
chap6-subchapII-sec136a.pdf"
http://www.gpo.gov/fdsys/pkg/USCODE-2011-title7/pdf/USCODE-2011-title7-c
hap6-subchapII-sec136a.pdf

ATTACHMENT I:	Pesticide Registration Improvement Act (PRIA)

 	  HYPERLINK
"http://www.gpo.gov/fdsys/pkg/PLAW-110publ94/pdf/PLAW-110publ94.pdf"
http://www.gpo.gov/fdsys/pkg/PLAW-110publ94/pdf/PLAW-110publ94.pdf

ATTACHMENT J:	Pesticide Registration Improvement Renewal Act (PRIA 2)
Related applications and Their Fees (Primary and Secondary)

  HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/related-apps.html"
http://www.epa.gov/pesticides/regulating/fees/related-apps.html

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

			  HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm"
http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm

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

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

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

ATTACHMENT O: 	PRIA 2: Fees for Registration Applications

  HYPERLINK "http://www.epa.gov/pesticides/regulating/fees/"
http://www.epa.gov/pesticides/regulating/fees/

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

     	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.

September, 2012

 PAGE

  PAGE  4  of   NUMPAGES  19

 PAGE   2


[Federal Register Volume 86, Number 25 (Tuesday, February 9, 2021)]
[Notices]
[Pages 8829-8830]
[FR Doc No: 2021-02659]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2013-0442; FMCSA-2014-0216; FMCSA-2015-0322; FMCSA-
2015-0323; FMCSA-2016-0007; FMCSA-2016-0008; FMCSA-2018-0056]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of final disposition.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces its decision to renew exemptions for 11
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates provided
below.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Dockets Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2013-0442, FMCSA-2014-0216, FMCSA-2015-
0322, FMCSA-2015-0323, FMCSA-2016-0007, FMCSA-2016-0008, or FMCSA-2018-
0056, in the keyword box, and click ``Search.'' Next, click the ``Open
Docket Folder'' button and choose the document to review. If you do not
have access to the internet, you may view the docket online by visiting
Dockets Operations in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between
9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.
To be sure someone is there to help you, please call<PHONE_NUMBER> or
(202) 366-9826 before visiting Dockets Operations.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On November 30, 2020, FMCSA published a notice announcing its
decision to renew exemptions for 11 individuals from the epilepsy and
seizure disorders prohibition in 49 CFR 391.41(b)(8) to operate a CMV
in interstate commerce and requested comments from the public (85 FR
76655). The public comment period ended on December 30, 2020, and no
comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that renewing these exemptions would achieve a level of
safety equivalent to, or greater than, the level that would be achieved
by complying with Sec.  391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in Sec.  391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce.
---------------------------------------------------------------------------

    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Conclusion

    Based on its evaluation of the 11 renewal exemption applications,
FMCSA announces its decision to exempt the following drivers from the
epilepsy and seizure disorders prohibition in Sec.  391.41(b)(8).
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of December
and are discussed below.
    As of December 3, 2020, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following seven individuals have satisfied the
renewal conditions for obtaining an exemption from the epilepsy and
seizure disorders prohibition in the FMCSRs for interstate CMV drivers
(85 FR 76655):

Nicolas Donez, Jr. (CO)
Michael C. Grant (SC)
Larry G. Hediger (IL)
Thomas K. Mitchell (MS)
Isaac E. Rogers (IL)
Donald J. Smith (NY)
Joseph A. Thomas (MD)

    The drivers were included in docket number FMCSA-2013-0442, FMCSA-
2014-0216, FMCSA-2015-0322, FMCSA-2016-0007, and FMCSA-2018-0056. Their
exemptions were applicable as of December 3, 2020, and will expire on
December 3, 2022.
    As of December 21, 2020, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following four individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers (85 FR
76655):

Douglas Cantwell (TN)
Kenneth B. Elder (KY)
Ronnie D. Moody (NC)
Tara VanHorne (PA)

    The drivers were included in docket number MCSA-2015-0323 and
FMCSA-2016-0008. Their exemptions were applicable as of December 21,
2020, and will expire on December 21, 2022.
    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315(b).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2021-02659 Filed 2-8-21; 8:45 am]
BILLING CODE 4910-EX-P