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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:

(1) 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.

(2) 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).

(3) Time-limited tolerance (or an exemption there from) to permit the sale of commodities 
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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 
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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:

(1) special protection for infants and children;

(2) aggregate exposure and risk from foods and other known sources, such as drinking water 

and household pesticide use;

(3) consideration of common mechanisms of toxicity (some chemicals have different 

molecular structures but cause deleterious effects in the same manner); and,

(4) 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 nonoccupational 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 newlyregistered 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).1 EPA encourages petitioners to submit supplemental information with their 

 

 1 PR Notice 97-1 applies to most applicants with registration applications, non-crop-destruct experimental 
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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 

 

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.
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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 
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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 
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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).
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(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 decisionmaking 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.

5. 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.
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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 
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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. 
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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.
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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
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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 industry2(NAICS 541600). Using the Agency’s burden estimate and fullyloaded 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

 

2

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

Michigan State University, May 25, 2007, http://ir4.rutgers.edu/Other/IR4EconomicImpact.pdf.
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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 reviews3. 

 

 3 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.
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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 Activities4

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 

 

 4 The FTE burden in SRRD and FEAD for each labor category (managerial, technical and clerical) amounted 

to significantly less than 1 FTE. The estimate for the Agency FTE for each labor category was rounded up to account 

for the contribution of FEAD and SRRD to the tolerance petition FTE burden.
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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 
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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-HQOPP-2012-0744, which is available for online viewing at 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 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)

http://uscode.house.gov/uscodecgi/fastweb.exe?getdoc+uscview+t21t25+149+1++%28%29%20%20AND%20%28%28

21%29%20ADJ%20USC%29%3ACITE%20AND%20%28USC%20w%2F10%20%283

46a%29%29%3ACITE%20%20%20%20%20%20%20%20%20

ATTACHMENT B: Accomplishments under the Food Quality Protection Act 

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

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

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

ATTACHMENT E: Public Comment (Reserved)

ATTACHMENT F: Electronic Submission Interim Guidance Documents

http://www.epa.gov/pesticides/regulating/registering/submissions/

ATTACHMENT G: 7 USC 450i: Competitive, special, and facilities research grants

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: 

http://www.gpo.gov/fdsys/pkg/USCODE-2011-title7/pdf/USCODE-2011-title7-chap6-

subchapII-sec136a.pdf

ATTACHMENT I: Pesticide Registration Improvement Act (PRIA)

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)

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

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

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

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

Costs
2

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

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