September, 2012

1 of 19 **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 I CR No. 0597.1 1 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 Env ironmental 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 sub mitted analy tical methods. I f 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 toleran ce. There are basically

three ty pes 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 establi shed 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 exempt ion 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 b e 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 I CR does not cover EUP related tolerance information co llection activities, which are covered by the I CR entitled, Application for Experimental Use Permit (EUP) to Ship and Use a Pesticide for Experimental Purposes Only (OMB Control #2070

- 0040, EPA I CR No. 0276). (3) Time

- limited tolerance (or an exemption there from) to permit the sale of commoditiesSeptember, 2012

2 of 19 containing residues resulting from a pesticide whose use was authorized under Section 18 of FIFRA. Under FI FRA § 18, EPA may allow States to use a pesticide for an unregistered use for a limited time if EPA determin es 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 tol erances 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 unde r FIFRA § 18. This I CR does not cover information collection related to FIFRA § 18 tolerance activities, which is collected under the I CR entitled, Application and Summary Report for an Emergency Exemption for Pesticides (OMB Control #2070

- 0032, EPA I CR No. 0596). This I CR 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 ei ther 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 individ ual 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 re sidue 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 res idue 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 o n food, or (b) an exemption from the requirement to have a tolerance for such residue. When initiatingSeptember, 2012

3 of 19 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 pestici de 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 I CR 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. I n addition to dietary exposure, such sources as dr inking 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 expos ure 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 sub mit any additional information under this I CR 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 ty pes 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 in formation with their
1 PR Notice 97

- 1 applies to most applicants with registration applications, non

- crop - destruct experimentalSeptember, 2012

4 of 19 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 o ther 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 deter mination 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 betw een 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 publish ing a Federal Register (FR) Notice announcing th e 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 I CR respondents and data users about spe cific aspects of I CRs before submitting an original or renewal I CR to OMB for review and approval. During the development of this renewal I CR, EPA staff will contact appropriate stakeholders and ask them for their assessment of the regulatory

burden estim ates expressed by the Agency

in this I CR. 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 mo st future applicants seeking new or amended pesticide registrations and all actions involving synthetic chemicals, antimicrobial, biochemical and microbial pesticides.September, 2012

5 of 19 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 informatio n 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 pestic ides 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 regulator

y 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 hy brid 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 electro nic 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 ho pes 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 dev elop 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** Tr ade 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 Agen cy , theSeptember, 2012

6 of 19 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 In formation Security

Manual. **3(g). Sensitive Questions** Not a pplicable. 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 includ e 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 ty pically 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 Sy stem (NAI CS) codes for all of the potential respo ndents, the NAI CS code s for the most frequent ty

pe of respondent are : Respondent Category NAI CS code Examples of potentially affected entities Pesticide and other agricultural chemical manufacturing 325320 In dividuals or entities engaged in acti vities related to the registration of a pesticide product. Management, Scientific, and Technical Consulting Services 5416 00 Establishments primarily engaged in administrative management and general management consulting s ervices

. **4(b). Information Req uested**  **(i) Data Items, Including Record Keeping Requirements** Inaddition 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 pesticideSeptember, 2012

7 of 19 chemica l. I f 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 In clude reports of investigations made with respect to the safety

of the pesticide chemical. These rep orts 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 resid ue remaining, including description of the analy tical 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 Pr oposed tolerances for the pesticidal chemical if specific tolerances are being proposed. Grounds for petition Reasonable grounds in support of the petition. Supplemental information Analy sis 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. I f data have already be en 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 ( s ee Attachment H ).September, 2012

8 of 19 **(ii) Respondent Activities** Inorder for a tolerance to be established for a pestic ide 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 toler ance 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 analy

tical methods
 *I f review is conducted by I R

- 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 Agenc y 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 Collect**  **ed -**  **Agency Activities, Collection Methodology, and Information Management**  **5(a) Agency Activities**  Upon receipt of a tolerance petition, EPA performs the following activities:
Lo g Receipt Lo g petition and associated fee. Review petition Screen peti tion, fee, and supporting data for complete ness and acceptability ; resolve any deficiencies with petitioner. Prepare Federal Register notice Upon acceptance, publish notice of filing in Federal Register.September, 2012

9 of 19 Review data Review supporting residue chemis try , toxicology data and other assessments received. Test analy

tical methods Test proposed analy tical methods in EPA laboratories, if they are new or modified. Integrate review Integrate data reviews and determine adequacy ; resolve any deficiencies w ith 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 subs equent 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 toler ance 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 commoditie s 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 ty

pe 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 coll ection. 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 I CR renewal estimates that an average o f 1 37 tolerance petitions will be submitted to the Agency

each year for the next three years. The Agency estimates that anSeptember, 2012

10 of 19 average of 11 1 of the 1 37 tolerance petitions will be submitted directly by petitioners , and 2 6 will be submitted by

I R

- 4. This est imate is based on the average number of tolerance petitions received by

the Agency

in the past three years (200 9 , 20 10 , and 20 11 ), and is an increase from the estimate in the previous I CR of 34 tolerance petitions. The Agency estimates that the average pa perwork 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 hour s required to process each IR

- 4 petition is due to a fee waiver incentiv e to submit label amendments with the registration package and the tolerance peti t ions. T he Pesticide Registration Improvement Act (PRIA) of 2003 renewed under PRIA 2, established r egistration 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 b ecame effective retroactively

on October 1, 2007. To qualify for the I R

- 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 w ell as any precautionary

and advisory

statements under the propos ed tolerance. Thus, I R

- 4 is conducting more preliminary review s for the label amendments, which has resulted in a slightly

increased burden when compared with the o ther petitioners. (See Atta chment 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. F QPA amendments also allow anyone to submit a petition, where previously

only registrants could submit the petitio n . 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 s ome of the petitions seems to indicate petitioners are tak ing advantage of at least the crop grouping flexibility where s ome have sought as many as 15 crops per petition

. Section 408 of FFDCA requires petitioners submit an information summary of the peti tion 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 pe titions, the Agency provided a description of the ty pes of information that EPA considers helpful in the appendices to Pesticide Registration (PR) Notice No. 97

- 1

.September, 2012

11 of 19 EPA continues to encourage petitioners to develop new and/or submit any existing suppleme ntal 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, am ong 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 ty pes of respondent burden are considered in this analy sis : 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, comply ing with good laboratory

standards in conducting the tests, and storing testi ng information in files are included in the technical burden estimates for this I CR. The Agency ’s estimate of petitioner burden was largely developed f

rom the previous Tolerance Petition I CR, using informatio n from the regulated community

. The informatio n 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 chang ing 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 I C R 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 ty pe 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 20 11 base data. Unloaded W

age Rate: Wages are estimated for labor ty pes (management, te chnical, and clerical) within applicable sectors. The Agency uses average wage data for the relevant sectors available in the National Industry

- Specific Occupational Employ ment and Wage Estimates from the Bureau of Labor Statistics (BLS) at http://www.bls. gov/oes/current/oes_nat.htm

.September, 2012

12 of 19 Sectors: The specific North American Industry Classification Sy stem (NAI CS) 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 sy stem 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 W

age 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 applicabl e; the applicable percentage will be stated. Fully Loaded W

age 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

loade d rates and overhead costs for all respondents ( tolerance petitioners and petitioners who submit through IR

- 4 ) and the Agency for this I CR renewal are listed in Attachment

s L , M, and N respectively

.
**Table 1. PETITIONER**  **BURDEN/COST ESTIMATES**

ACTIVI TI ES HOU RS 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 $ 1 4,318 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 , 20 11

. (See cost worksheet Attachment L ). **Table 1. IR -**  **4 BURDEN/COST ESTIMATES PER PETITION**

ACTIVI TI ES HOURS and RATES COSTS (per petition) Mgmt. $1 41 /hr Tech.

$ 7 6 /hr Cler. $ 3 9 /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 $ 118,587September, 2012

13 of 19 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, 20 11

. (See cost worksheet Attachment M ). Labor rates are fully

loaded and include benefits and overhead costs applied using procedures outlined i n 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, phy sical and social scie nce 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 L abor, Bureau of Labor Statistics. For tolerance petitioners , the value of labor per hour for manag ement, technical, and clerical i s $ 156, $81 and $46 respectively . L abor rates are by occupation for the Research and Development in the Phy sical, Engineering, and Life Sciences industry (NAI CS 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 11 1 petitions per year, is estimated to be $ 1 7,461,52 1

. For I R

- 4, the value of labor per hour for management, technical, and clerical is $ 1 41 , $7 6 , and $ 3 9 , respectively . L abor rates are by occupation for Management, Scientific, and Technical Consulting Services industry 2 (NAI CS 541600 ). Using the Agen cy ’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 2 6 petitions per year , is estimated to be $ 3, 819,400

. The overall annual cost to respondents associated with this information collection, including petitioners and I R

- 4, based on an average total estimate of 137 petitions per year, is estimated to be $ 21,2 8 0, 921

. **ANNUAL COSTS:**  In dustry Management: 323 hours * $1 56 per hour * 11 1 tolerance petitions = $ 5,5 93,068 Technical: 1,211 hours * $ 81 per hour * 11 1 tolerance petitions = $ 10, 888,101 Clerical: 192 hours * $4 6 per hour * 11 1 tolerance petitions = $ 9 80,352 In dus try 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

.September, 2012

14 of 19 IR

- 4 Management: 336 hours * $1 41 per hour * 2 6 tolerance petitions = $1, 2 31,776 Technical: 1,211 hours * $ 7 6 per hour * 2 6 tolerance petitions = $ 2, 392,936 Clerical: 192 hours * $ 3 9 per hour * 2 6 tolerance petitions = $ 194 ,688 IR

- 4 TOTAL: $ 3, 819,400 GRAND TOTAL: $ 21,2 8 0, 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 analy sis assumes that on e respondent will generate the data for a given petition. I f 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 pes ticide decisions, and couples the collection of individual fees with specific decision review periods. PRIA 2 also promotes shorter decision review periods for different ty pes of pesticide applications. PRA burden hour and cost estimates for the PRIA program have been OMB approved under the Pesticide Registration Fee Waivers I CR (OMB Control No. 2070

- 0167; EPA No

. 2147 ) and are not included in the estimates for this I CR. The program reconfigured internal organizations to meet these new challenges, which h as reduced the PRA burden hours and costs for the petitioners , and increased PRA burden hours and costs on the Agency under this I CR. For this I CR renewal, the Agency is using data on internal OPP Divisions that provide significant support and analy sis fo r the FIFRA tolerance petition I CR program. This data is taken from the Time and Attendance Information Sy stem (TAI S), which archives the Agency ’s Full Time Equivalents (FTEs) for most OPP program activities (see Attachment P ). The Agency burden calculatio ns reflect activities for the tolerance petition I CR 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 Hea lth and Effects Division (HED), the Biological and Economic Analy sis 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 refl ects that (8) OPP Divisions work together to complete the activities related to OPP tolerance petition reviews 3

. 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 activitie s 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 breakdow

n by ICR activity.September, 2012

15 of 19 The Agency

believes that using data from the TAI S reflects the internal operations for implementing and administering tolerance petition activ ities

. Using TAI S. the estimated number of Agency FTE’s dedicated to tolerance petition activities is approximately 1. 3 1 managerial FTEs as shown in Table 2, 1 1.88 technical FTEs as shown in Table 3, and 0.3 6 clerical FTEs as shown in Table 4. The aggreg ated Agency estimated FTE dedicated to tolerance petition activities is 1 4 . The associated Agency burden hours are 2 8 , 17 2 , assuming 2,080 hours per FTE.
**Table 2**

**– Distribution of Agency Managerial FTEs Supporting Tolerance Petition**  **Activities 3**  AD BEA D BPPD EFED FEAD HED RD SRRD <1 <1 <1 <1 <1 <1 < 1 <1 Agency total 1. 3 1 Annual Agency

burden hours were calculated using the number of hours per FTE multiplied by the number of FTE’s (2080 * 1. 3 1 = 2, 725 ). **Table 3**

**– Distribution of Agency Technical F**  **TEs Supporting Tolerance Petition Activities 4**  AD BEAD BPPD EFED FEAD HED RD SRRD <1 <1 <1 <1 <1 2. 87 7. 96 <1 Agency total 1 1.88 Annual Agency

burden hours were calculated using the number of hours per FTE multiplied by the number of FTE’s (208 0 * 11.88 = 2 4 , 711 ). **Table 4**

**– Distribution of Agency Clerical FTEs Supporting FIFRA Tolerance Petition**  **Activities 3**  AD BEAD BPPD EFED FEAD HED RD SRRD <1 <1 <1 <1 <1 <1 <1 <1 Agency total 0.3 6 Annual Agency

burden hours were calculated using the number of hours per FTE multiplied by the number of FTE’s (2080 * 0.3 6 = 748 ). To determine Agency

costs, the Agency

used the Bureau of Labor Statistics estimates of labor rates for the North American Industry Classification Sy stem (NAI CS) code for the Federal Exe cutive Branch (NAI CS 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, phy sical and social science occupations; and the clerical labor rat e is based on the SOC for office and administrative support occupations. The labor rates are fully loaded and indexed to 20 11 dollars. The fully loaded hourly

mean wage rate estimate for managerial

4 The FTE burden in SRRD and FEAD for each labo r 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

16 of 19 occupations is $1 20 for an average annual FTE cost of $ 2 49,600 ($1 20 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 , 0 8 0)

. Fo r clerical occupations, the fully loaded mean wage rate is $4 4 for an average annual FTE co st of $ 91,520 ($44* 2,080) . (See Worksheet for NAI CS 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 multip lied 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 ( 1 1.88 FTE * $ 162,240 per FTE); and clerical costs are $ 32 , 947 ( 0.3 6 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 2 8 , 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 IC R due to increased efficiency in petition processing ove r the last three years. The Agency estimates that an average of 13 7 tolerance petitions will be received annually . This is a n increase of 3 4 tolerance petitions annually . The estimate is based on the average number of tolerance petitions received by

the Agency

in the years FY200 9 , FY20 10 , and FY20 11

. The decrease in hours and costs reflects internal program adjustment s. **Petitioners (Respondents)**  EPA estimates a net increase of 58,515 burden hours annually over the expiring I CR. This increase is a result of an increase from 103 to 137 in the estimated average number of tolerance pe titions 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. The re is no change in burden per tolerance petition ; b urden 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 toleranceSeptember, 2012

17 of 19 petitions is estimated to average 1,7 2 6 hours for petitions submi tted 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 sy stems for the purposes of colle cting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing way s 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 I CR un der Docket I D No. EPA

- HQ

OPP

- 20 12

- 07 44 , 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 Cons titution Avenue, NW, Washington, DC. This docket facility is open from 8:30 a.m. to 4 :30 p.m., Monday

through Friday , excluding federal holiday s. 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 D ocket I D No. EPA

- HQ

- OPP

- 20 12

- 07 44 and OMB control number 2070

- 0024 in any corr espondence but do not submit information under this collection to these addresses.**Attachments List: Supporting Statement ( EPA**  **- HQ**  **- OPP**  **- 20**  **12 -**  **07 44**  **)**

All of the attachments listed below can be found in the docket for this I CR (unless otherwise noted); accessi ble 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

- 20 12

- 07 44 in the **Docket ID** f ield. 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/uscode

cgi/fastweb.exe?getdoc+uscview+t21t25+149+1++%28%29%20%20AND%20%28%2 8 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.ep a.gov/pesticides/regulating/registering/submissions/ **ATTACHMENT G**  **: 7 USC 450i:**  **Competitive, special, and facilities research grants** http://www.csrees.usda.gov/funding/nri/nri_7us c450i.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.pd f **ATTACHMENT I :**  **Pesticide Registration Improvement Act (PRIA)** http://ww w. gpo.gov/fdsys/pkg/PLAW

- 110publ94/pdf/PLAW

- 110publ94.pdf **ATTACHMENT J: Pesticide Registration Improvement Renewal Act (PRIA 2) Related** 

**a pplications 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/pestic ides/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 Fe**  **deral 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 (T AIS) Plan Program** 

**A ccomplishment (PPA) Codes Used to Calculate EPA and Federal**  **Government Burden Hours**