May 9, 2014

Page 1 of 16 SUPPORTING STATEMENT

FOR AN INFORMATION COL LECTION REQUEST (ICR)

1. IDENTIFICATION OF THE IN FORMATION COLLECTION

1(a) Title:

Plant-Incorporated Protectants; CBI Substant iation and Adverse Effects Reporting

OMB No.: 2070-0142 EPA ICR No.: 1693.08

1(b) Short Characterization/Abstract

The Environmental Protection Agency (EPA) is responsible for the regulation of pesticides as authorized by the Federal Insect icide, Fungicide, and R odenticide Act (FIFRA). Prior to EPA granting a registration, the manufactu rer of the pesticide must demonstrate to the Agency that the use of the pest icide product will not result in any unreasonable adverse effects to

humans or the environment. EPA is also responsible under the Federal Food, Drug, and Cosmetic Act (FFDCA) for establishing a tolera nce or exemption from the requirement of a tolerance for pesticide residues on food or feed.

The Agency promulgated a final rule (codifi ed at 40 CFR part 174) that addresses the regulatory status of pesticidal substances that are produced by plants (plant-incorporated protectants). A plant-incorporated protectant (PIP) is defined in the final rule as “the pesticidal

substance that is intended to be produced and used in a living plant and the genetic material necessary for the production of such a substanc e.” The rule (Attachment A) exempts a wide range of PIPs from registration requirements under FIFRA, and it imposes two requirements on

manufacturers of some PIPs.

This Information Collection Request (ICR) c overs the two information collection related provisions contained in the rule , i.e., the provision that re quires registrants that make Confidential Business Information (CBI) claims to substantiate such claims when they are made, and the provision that requires ma nufacturers of PIPs exempted from requirements of registration under the final rule to report a dverse effects to the Agency. Th e current CBI regulations at 40 CFR part 2 require that claimant s substantiate their CBI claims for their own records when the claim is made, and subsequently provide the substantiation to EPA onl y if requested. The substantiation, however, is not required to be in cluded with the submission to EPA in which the

CBI claims are made. The burden associated wi th the existing requirement for CBI claims pursuant to 40 CFR part 2 is already a pproved by OMB under OMB Control No. 2020-0003.

Although 40 CFR part 174 requires the claimant to include the CBI s ubstantiation in the PIP- related submissions to EPA, it is difficult to identify any additional burden that such a requirement might actually impose. Neverthele ss, the Agency has chosen the conservative approach of including potential burden and costs for preparing and submitting the CBI

substantiation at the time of su bmission of the information containing the CBI claim as required by the rule.May 9, 2014

Page 2 of 16 The provisions of 40 CFR 174 that are related to information collec tion activities which are part of registration activities , e.g., data requirements for pest icide registrations, are already approved by OMB under the PRA, and that appr oval is not impacted by the clar ification provided in the final rule. Information collection activities related to pesticide registration are approved under OMB Control Nos. 2070-0060 (App lication for New or Amended Pesticide Registration), 2070-0024 (Tolerance Petitions for Pesticides on Food/Feed Crops and New Inert Ingredients), and 2070-0040 (Experimental Use Perm its (EUPs) for Pesticides). This ICR, therefore, discusses the paperwor k burdens associated with the requirement for registrants to substantiate CBI claims when they are made, and the requirement for manufacturers of PIPs exempted from registration requirements under the final rule to report ad verse effects to the Agency within 30 days.

2. NEED FOR AND USE OF THE COLLECTION

2(a) Need/Authority for the Collection

Although FIFRA requires the registration of pe sticides, it also authorizes the Agency’s regulation of unregistered pesticides. FIFRA section 3(a) provides that, to the extent necessary to prevent unreasonable adverse effects on the e nvironment, the Administrator may limit the distribution, sale, or use of any pesticide that is not registered under section 3 of FIFRA, or subject to an experimental use permit under sec tion 5 of FIFRA, or subject to an emergency exemption under section 18 of FIFRA. Pesticides that are "not registered" in clude pesticides that are exempt from FIFRA requirements under section 25(b) (Attachment B).

FIFRA section 2(bb) defines the term "unreas onable adverse effects on the environment" to mean: “(1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and bene fits of the use of any pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food

inconsistent with the standard under section 408 of the Federal Food, Drug, and Cosmetic Act” (7 U.S.C. 136(bb)).

Section 25(b)(2) of FIFRA allows EPA to exempt, by regulation, any pesticide from some or all of the requirements of FIFRA, if the pesticide is of a character which is unnecessary to be subject to FIFRA in order to carry out the purposes of th at Act (7 U.S.C. 136w(b)(2)). EPA interprets FIFRA section 25(b)(2) to authori ze EPA to exempt a pes ticide or category of pesticides that EPA determines poses a low probabili ty of risk to the environment, and that is not likely to cause unreasonable adverse effects to th e environment even in the absence of regulatory oversight under FIFRA.

To determine whether a pesticide qualifies for an exemption under section 25(b)(2), EPA evaluates both the potential risks and benefits of the use of the pe sticide. In evaluating a pesticide under the first exemption criterion, whether use of the pesticide poses a low probability of risk to the environment, EPA considers the extent of the potential risks caused by use of the pesticide to the environment, including humans and other animal s, plants, water, air and land. Potential risks to humans include dietary risks as well as non- dietary risks such as those resulting fromMay 9, 2014

Page 3 of 16 occupational or residential exposure to the pestic ide. EPA uses the FFDCA section 408 standard in evaluating dietary risks. EPA will not exempt pesticides under section 25(b)(2) that fail the low probability of risk criterion.

In evaluating a pesticide under the second ex emption criterion, whether the use of the pesticide is likely to cause unreasonable advers e effects on the environment even in the absence of regulatory oversight under FIFR A, EPA balances all the poten tial risks to human health, including any dietary risks, and risks to the remainder of the environment from use of the pesticide against the potential benefits associated with its use. In balancing risks and benefits, EPA considers the economic, social, and environm ental costs and benefits of the use of the pesticide. If the pesticide meets both exempti on criteria, EPA may exempt the pesticide from regulation under FIFRA section 25(b)(2).

Under FFDCA section 408(a) (Attachment C), a pesticide chemical residue in or on food

is not safe unless EPA has issued either: a tolera nce for the residue and th e residue is within the tolerance limits, or an exemption from the require ment of a tolerance for the residue (21 U.S.C. 346a(a)(1)). FFDCA section 408 authorizes EPA to determine a residue is safe and exempt from the requirement of a tolerance if the Administrator “. . . has determined that there is a reasonable certainty that no harm will result from aggreg ate exposure to the pesticide chemical residue, including all anticipated dietar y exposures and all other exposur es for which there is reliable information” (21 U.S.C. 346a(c)(2)(A)). Sec tion 408 of the FFDCA also directs EPA to specifically consider harm that may result to infa nts and children as a result of pesticide chemical

residues.

A determination that a pesticide chemical m eets the safety standard of section 408(a) of the FFDCA may also be relevant to whether a pesticide qualifies for a FIFRA section 25(b)(2) exemption with respect to human health risks ar ising from other routes of exposure. However, FIFRA does not provide for exemp tion of a pesticide in food base d solely upon consistency with the FFDCA section 408 exemption standard. At a minimum, EPA also must evaluate risks arising from occupational expos ure to humans and determine that such risks meet both exemption criteria. In addition, EPA must eval uate the risks to the environment from the pesticide and determine both that the pesticide poses only a low probability of environmental risks, and that use of the pest icide is not likely to cause any unreasonable adverse effects on the remainder of the environment in the absence of regulation under FIFRA.

2(b) Practical Utility/Users of the Data

EPA believes that requiring the substantiation of CBI claims for PIPs at the time of submission to the Agency will help ensure a timely EPA response to submissions for PIPs, protect the public’s right to access information consistent with FIFRA, and ensure that information qualifying as CBI is properly prot ected from unauthorized disclosures. Since registrants are already required to ensure that CBI claims are pr oper prior to asserting the CBI protection for information submitted to EPA, this requirement simply affects the time at which the substantiation is submitted to the Agency, i.e. , it requires the inclusion of this substantiation

with the submission.May 9, 2014

Page 4 of 16 The Agency’s analysis of the potential risks a nd benefits of PIPs has led it to conclude that the categories of PIPs described in 40 CFR part 174, subpart B warrant exemption. However, it is possible that there may be unfores eeable adverse effects to human health or the environment from the testing and use of otherwise exempted PIPs, as the exemptions at subpart B are broad and cover literally thousands of potential substances , some of which under certain use conditions have the potential to be toxic. The Agency therefore included, as a condition of exemption, a requirement to report to EPA within 30 days any factual adverse effects associated with these otherwise exempt PIPs. These repo rting requirements are similar to reporting requirements imposed on registrants under FIFRA section 6(a)(2) for registered pesticides. However, since the 6(a)(2) reporting requirement a pplies to registered pesticides and many PIPs are exempted from registration requirements, the separate reporting requirement is necessary in order to obtain any information on unforeseen adverse effects from the exempted PIPs.

The information supplied to substantiate cl aims of confidentiality will be used by the Agency to determine whether CBI claims comply with the confidentialit y provisions of FIFRA. Early substantiation of CBI claims will enable the Agency to promptly release information supporting PIPs registration decisions, without de laying registrations in order to obtain CBI

substantiation once a decision has been made to re gister a PIP, while still protecting legitimate

CBI.

The adverse effects reports on exempted PIPs w ill be utilized by the Agency to evaluate

adverse effects to determine if any additional regulatory actions ar e warranted. These reports will also enable the Agency to repor t to appropriate oversi ght bodies and the pub lic its evaluation of such adverse effects and will help support any additional decision on regulatory oversight.

3. NON DUPLICATION, CONSULTA TIONS, AND OTHER COLLECTION

CRITERIA

3(a) Non duplication

In fulfilling its mission as the Federal agency primarily responsible for the regulation of pesticides, EPA works closely with the U.S. Department of Agriculture (USDA) which has responsibilities under the Federal Plant Protec tion Act (FPPA), and the U.S. Food and Drug Administration (FDA) which has responsibilit ies under the FFDCA. EPA, USDA and FDA consult and exchange information when such consultation is helpful in resolving safety questions. The three agencies also strive for c onsistency between programs, adopting consistent approaches, to the extent permitted by the respect ive statutory authorities. A consistent approach between agencies is easier for th e regulated community to understa nd. It is also more likely to conserve resources, as submitters would more likely be able to use data developed for one agency to meet requirements posed by another agency for the same or similar products.

Generally, respondents are not required to submit applications or any other related data or information regarding testing to any other federal agency or to any other EPA program office. However, there may be requirements under the FPPA for plants that produce PIPs. Under the FPPA, the USDA's Animal and Plant Health Insp ection Service (APHIS) re gulates field testingMay 9, 2014

Page 5 of 16 of genetically altered plants, while EPA will have regulatory oversight of the pesticide substances produced by those plants. In in stances where review under the FPPA may be triggered, the respondent will need to contact AP HIS for a determination of whether the plant containing a PIP is a plant pest that will need a permit. In a ddition, registrants may be required

to obtain an EUP for PIPs-related field trials. In such cases, re gistrants would be expected to comply with the applicable EUP requirements. As described in section 1(b) of this supporting statement, the paperwork activities associated with EUPs are addressed in a separate ICR. In any case, there is no known duplication related to the requirements cove red in this ICR, i.e., the upfront CBI substantiation or the submission of adverse effects re ports for exempted PIPs. Each respondent must submit information unique to his/he r product application, or allegation received, and will do so only once on occasion.

3(b) Public Notice Required Pr ior to ICR Submission to OMB

EPA published a notice in the Federal Re gister announcing a 60-day public notice and comment period on the draft ICR on Septembe r 25, 2013 (78 FR 59014). EPA received no public comment in response to this notice, which is av ailable in the docket for this ICR and can be

accessed at http://www.regulations.gov using the docket identifier EPA-HQ-OPP-2013-0494.

3(c) Consultations

In addition to the public notice that EPA pub lished in the Federal Register concerning the renewal of this ICR, as required under 5 CFR 1320.8(d)(1) the Agen cy consulted with stakeholders who actively interact with the Agen cy through the use of this collection instrument. The consultation respondents who re plied to EPA’s consultation reque st generally agreed that the burden estimate in the ICR were reasonable, and did not have specific su ggestions for improving or clarifying the current colle ction. Therefore the Agency made no changes to the draft ICR

based on the consultations. A record of the cons ultations (Attachment D) is available in the public docket online at http://www.regulations.gov , referencing Docket ID No. EPA–HQ–OPP–

2013-0494.

3(d) Effects of Less Frequent Collection

Not applicable. The information is submitted eith er in conjunction with the application or when an adverse effect occurs for an exempt ed PIP. This activity is conducted only once per "event," and therefore, there are no availa ble means by which the Agency can reduce the frequency.

3(e) General Guidelines

The collection activities covered by this ICR comply with the guidelines provided under the PRA and the implementing regulations issued by OMB.

In accordance with 5 CFR 1320.5(a)(iii)(E), fe deral agencies are required to indicate whether the proposed collection of information involves the us e of automated, electronic, mechanical, or other technologi cal collection techni ques or other forms of informationMay 9, 2014

Page 6 of 16 technology, e.g., permitting electronic submission of responses, and an explanation of the

decision. At this time of this renewal, EPA’s Office of Pesticid e Programs (OPP) is not offering a fully electronic submission option. The Agency is actively working to extend full electronic submission options in keeping with the re cent Executive Order on "R educing Reporting and Paperwork Burdens" and other re lated policy and guidance. In the future, the Agency hopes to be able to offer a fully electronic submissi on 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 effo rts to develop information technology approaches to adequately protect FIFRA Confidential Business Information submitted over the Internet.

3(f) Confidentiality

Although the EPA urges submitters to minimize the amount of information that is claimed as CBI, any data and/or information submitted to the Agency may be claimed as trade secret, or commercial or financial information a nd will be protected from disclosure by the EPA under FIFRA section 10 and the associated regulati ons as contained in 40 CFR Part 2, Subpart B.

When information that is claimed as trade s ecret or CBI is provided to the Agency, such information is subject to the protections and pr ocedures set forth in FIFRA Section 10. Nothing in this rule affects those protections.

Even if a registrant fails to include the re quired substantiation for any CBI claims made in the PIP application when that application is submitted to EPA, the Agency intends to still

handle such claims in accordance with the FI FRA Confidential Business Information Security

Manual. This manual contains instructions relati ve to all contact with confidential documents, including responsibility of EPA employees, physical security m easures, CBI materials within EPA, CBI typing procedures (documents typed inte rnally or by contract ), and interdivisional routing procedures. The manual dictat es all CBI must be marked or flagged as such, that it must be kept in secure, i.e., double-locked areas, and that all CBI to be destroyed must be cleared by a document control officer and pla ced in EPA's paper shredder.

3(g) Sensitive Questions

Not applicable. No information of a sensitive or private nature is requested in conjunction with this collection activity. Further, this in formation collection activity complies with the provisions of the Privacy Act of 1974 and OMB circular A-108.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a) Respondents/NAICS Codes

The respondents for the information collecti on activities contained in this ICR include producers and importers of PIPs. These entities may be classi fied under the following North

American Industrial Classificat ion System (NAICS) codes:

32532 Pesticides and Other Agricu ltural Chemical ManufacturingMay 9, 2014

Page 7 of 16 54171 Research and Development in the Physical, Engineering, and Life

Sciences

325414 Biological Products (except Diagnostic) Manufacturing

611310 Colleges, Universities, and Professional Schools

422910 Farm Supplies Wholesalers

422930 Flower, Nursery Stock, and Flor ists’ Supplies (Wholesalers)

4(b) Information Requested

4(b)(i) Data items, including record keeping requirements

Registrants must continue to review the re gulations regarding CBI, review the materials in their submission for which claims are being made; and ensure that CBI claims are properly made. Pursuant to 40 CFR 174, registrants must submit substantiation for any CBI claim made for information for PIPs submitted to EPA. The Agency is not imposing any new requirements regarding the basis for making a CBI claim, or the points that must be addr essed to substantiate any CBI claim that is made. These requirements already exist in 40 CFR part 2. In addition, EPA is not imposing any specific form or format for these substantiations. (See 40 CFR 174.9)

Manufacturers of PIPs exempted from regist ration requirements must submit to EPA any information they subsequently obtain regard ing adverse effects on human health or the environment alleged to have been caused by the exempted PIP. The Agency anticipates that the

entities will obtain adverse effects information dur ing the normal course of business, and then will make a report to the Agency with adequate background information for the Agency to be

able to make a decision to either ask for additional information or to act on the information presented. The Agency does not foresee any extra data collection effort to find adverse effects beyond the normal course of busine ss but rather envisions these effects being discovered from ongoing studies of various PIPs or customer co mplaints. Although EPA speci fies the content of any adverse effects report submitted to EPA, EPA is not imposing any specific form or format for these reports. (See 40 CFR 174.71)

In addition, entities may also be asked to res pond to Agency questions that arise based on the submission, whether it be the CBI substantiati on, or the adverse effects report. Such followup activities are assumed as part of the initial burden estimates. Should further information be necessary, e.g., should the adverse effect information reported to EPA indicate the need for a study or other additional information, any additi onal Agency requirement would come in the

form of a data call-in covere d under the existing regulations and a separate ICR approved by OMB under Control No. 2070-0057, EPA ICR No. 922. This ICR is not intended to address such

activities.

4(b)(ii) Respondent Activities

The requirements for up-front CBI substant iation and adverse effects reporting are separate requirements that only occur on occasion. The CBI substantiation occurs when an entity is submitting PIP related information to EPA that contains CBI claims pursuant to 40 CFR partMay 9, 2014

Page 8 of 16 2. The adverse effects reporting occurs when an entity obtains information regarding adverse effects on human health or the environment allege d to have been caused by the exempted PIP.

Although each activity is distinct, a typical respondent fo r each activity is expected to engage in the following activities:

Activity Explanation Read Regulations The respondent needs to b ecome familiar with the regulations governing

CBI substantiation or adverse effects reporting as they pertain to PIPs.

Plan Activities The respondent must devel op/amend and implement a plan to ensure compliance with these requirements. The registrant is also encouraged to consult with the Agency.

Gather

Information The information necessary to provid e the required substantiation or any

information obtained on adverse effects must be assembled.

Review

Information The respondent must check the CBI substantiation for accuracy and completeness, or verify that the adve rse effects report accurately reflects the information they have obtained.

Complete Paperwork The information must be compiled into a document(s) or report(s) and prepared for submission to EPA.

Submit

Information The respondent must submit the information to OPP as required.

Store, Maintain,

and File

Information This information collection does not contain any recordkeeping requirements. Please note however th at FIFRA section 8, and the related regulations in 40 CFR part 169, require registrants to store and maintain certain information related to their pesticide products.

5. THE INFORMATION COLLECTED – AGENCY ACTIVITIES, COLLECTION METHODOLOGIES, AND INFORMATION MANAGEMENT

5(a) Agency Activities

The Agency must evaluate the CBI substantiations when submitted, and process any adverse effect reports for exempted PIPs when received. Although these activities are distinct and separate, the Agency is expected to engage in the following activities:

Activity Explanation

Consult with the registrant The Agency will respond to any que stions either in writing, or verbally via meetings or by te lephone, and provide any other assistance or guidance requested.

Record submissions Whether the submission involves an application package for the registration of a PIP, or an adve rse effects report for allegations related to an exempted PIP, the s ubmission is recorded or logged in by the Agency to document its receipt. The Agency will create anMay 9, 2014

Page 9 of 16 electronic record of the necessa ry information for routing and tracking purposes.

Review submissions The Agency will review the incoming materials with CBI claims to

evaluate the CBI substantia tions for completeness and appropriateness, and will review the incoming adverse effects reports to determine what, if any, substantive review or action might be necessary as follow-up to the alleged adverse effects.

Store the information The Agency will maintain the information contained in the submitted application package, including the CBI substantiation that was submitted, and will maintain any adverse effects report(s)

submitted.

5(b) Collection Methodology and Management

Respondents to this ICR providi ng substantiation of CBI claims at the time the claims are made must necessarily submit the information as pa rt of their larger package for registration of a pesticide product, since components of that package are claimed as CBI. Components of registration packages with CBI cl aims are currently submitted by mail. EPA is working to allow electronic submission of registra tion packages, include efforts to develop information technology approaches to adequately protect FIFRA Confidential Business Information submitted over the

Internet.

All information received by the Agency pe rtaining to CBI substantiation or adverse effects for exempted PIPs will be routed to th e Biopesticide and Polluti on Prevention Division (BPPD) in OPP. It will be pin-punched by date , screened, and entered into the Office of Pesticide Programs Information Network (OPPIN).

For registration packages involving PIPs, a file will be created and the application package will be forwarded to the appropriate Ma nager within BPPD. The Manager assures that the initial OPPIN entry is correct , reviews the information, and if necessary, routes the submitted data through scientific and/or administrative revi ew. If the scientific information indicates that the submission is deficient in any manner, the submitter has the option of attempting to correct the deficiency. If the submission indicates that information claimed as CBI warrants said claim, the applicant is notified and the information is ma rked as such. The Agency will continue current practice of treating information cl aimed as CBI as such, until a CBI determination is made. If a

determination is made that a CBI claim is not warranted or the claim is not substantiated, the registrant will be notified that the information cl aimed as CBI, does not qu alify as CBI because it does not meet the regulatory requirements. They will be given an opportunity to respond as provided in the existing regulations. The pack age will then be processed accordingly.

For adverse effects reports relate d to exempted PIPs, a file wi ll be created and the report will be forwarded to the appropriate product Ma nager within BPPD. The Manager assures that the initial OPPIN entry is corre ct, reviews the information, a nd determines the appropriate review and next steps based on the contents of the report, routing the re port through scientificMay 9, 2014

Page 10 of 16 and/or administrative review, as appropriate. If an adverse effect report indicates that additional action is warranted or necessary, the Ag ency will take appropriate action.

5(c) Small Entity Flexibility

In promulgating the requirements codifi ed at 40 CFR 174, the Agency considered potential small entity impacts, and has taken steps to minimize potential impacts to the extent permitted. EPA believes that the CBI substantiation is fairly easy to provide for information

which warrants CBI claims. The enti ty, regardless of size, is alre ady required to make the CBI determination prior to submitting its registration application to EPA. The rule simply requires that the information be provided with the submi ssion to substantiate the CBI claim. This is reflected in the relatively low cost estimate for CBI substantiation for a PIP submission. This relatively small cost represents a reasonable step to ensure the public has access to all nonconfidential information on PIPs once they are registered.

In addition, the Agency has taken steps to en sure that only the person who produces the exempted PIP for sale and distribution is res ponsible for adverse eff ects reporting, and only if they obtain the adverse effects information. Th e Agency has designed such reporting to be minimal and has placed the burden on the Agen cy to take additional action beyond the entity making the report.

5(d) Collection Schedule

The CBI substantiation occurs only upon submis sion of claims of c onfidentiality and the adverse effects reporting only occurs on occasio n. There is no collection schedule per se

associated with these collecti on activities. These activities ar e conducted once per submission.

6. ESTIMATING THE BURDEN A ND COST OF THE COLLECTION

6(a) Estimating per Respondent Burden and Cost

Burdens for this analysis consist primarily of the administrative burden associated with the drafting and submission of the CBI substantia tion and the adverse eff ects reports. The burden estimates are based on the Agency’s experience regarding existing burden estimates related to CBI substantiation and adverse effects report ing for conventional pe sticides, and provide reasonable estimates for the average time necessary to perform each activity for each submission.

Consistent with recent ICR renewals, OPP is using labor cost estimates from Agency economists with respect to wages, benefits and overhead for all labor categories for affected industries and EPA employees. This approach uses a transparent and consistent methodology employing publicly-available data to provide more accurate estimat es and allow easy replication

of the calculations.

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 +May 9, 2014

Page 11 of 16 benefits), and the Fully loaded wage rate (loaded wage rate + overh ead). Fully loaded wage

rates are used to calculate th e Agency’s staffing costs.

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

.

Sectors: The specific North American Indus try 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 Cl assification (SOC). The SOC system is used by Federal statistical agencies to classify worker s into occupational categor ies 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 44% 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 sect ors are listed for which 44% is not applicable; the appli cable percentage will be stated.

Fully Loaded Wage Rate: We multiply the loaded wage rate by 50% (EPA guidelines 20- 70%) to get overhead costs. Atta chment E contains worksheets pr oviding the breakout of these

costs. Costs are indexed to 2012 data.

To derive the labor rates fo r this ICR, Agency economists estimated the wages for the management, technical, and clerical labor ca tegories using the methodology described in Attachment E. The respondent costs for this rene wal for managerial, techni cal and clerical rates are estimated at $117.74, $62.58, and $37.33 per hour, re spectively. These labor rates are fully loaded (include benefits and overhead costs).

Since CBI substantiations are simply added to the registration application package and are not submitted separately, there are no additi onal costs related to the transmittal of this information to the Agency. The costs for subm itting the registration application package are already included under other existing ICRs. Th ese respondent burden and cost estimates may also represent an upper bound because the analysis assumes that all PIP-related registration applications may include information that the regi strants will claim as CBI which will need to be substantiated. It is likely that registrants will reco gnize, over time, that it is in their interest to make all information on PIPs publicly available to improve the transparency of the regulatory

process.

For purposes of this ICR, EPA is assuming th at no more than 60 PIP-related registration applications with associated CBI substantiati ons will be submitted over the three-year approval period for this ICR, or 20 per year. This estima te is based on EPA’s recent experience with PIP registration actions. Over the last two years there has been an average of 2 tolerance exemptions finalized, and two EUP applications . There has been an average of 13 applications for new PIP products, but this number has been trending up. Thus , instead of using the average for this ICR, the calculation uses the maximum, whic h was 16 applications in 2012.May 9, 2014

Page 12 of 16 Table 1 – Average Respondent Burden and Cost Estimates per Submission for

Substantiation of CBI Claims Made in a Pl ant-Incorporated Protectant Registration Application

Burden and Cost Estimates Totals Activities Mgmt. ($117.74/hr) Tech. ($62.58/hr) Clerical ($37.33/hr) Burden (hrs) Costs ($) Read Regulations 1 2 0 3 242.90

Plan Activities 2 4 0 6 485.80

Gather Information 0 4 0 4 250.32

Review Information 2 1 1 4 335.39 Complete Paperwork 0 1 2 3 137.24

Submit Information 0.5 0.5 0.5 1.5 108.83 Totals 5.5 12.5 3.5 21.5 1,560.48 Estimated Total Annual Respondent Burden: 20 events x 21.5 hours = 430 hours Estimated Total Annual Respondent Cost: 20 events x $1,560.48 = $31,210

Although the Agency does not anticipate any ad verse effect reports to be submitted forexempted PIPs, this ICR includes an estimate of one such report being submitted over the threeyear approval period for this ICR. The per-s ubmission estimate is therefore divided by 3 to provide an average annual burden an d cost to include in the total annual estimates for this ICR. The total annual average burden and costs for the a dverse effects report is calculated as follows:

Table 2 - Average Respondent Burden and Cost Estimates per Submission for Submitting an Adverse Effects Report for an Exempt Plant-Incorporated Protectant

Burden and Cost Estimates Totals Activities Mgmt. ($117.74/hr) Tech. ($62.58/hr) Clerical ($37.33/hr) Burden (hrs) Costs ($) Read Regulations 0.5 1 0 1.5 121.45

Plan Activities 0.5 0.5 0 1 90.16

Gather Information 0 1 0 1 62.58

Review Information 0.5 0.5 0 1 90.16 Complete Paperwork 0 0.5 1 1.5 68.62

Submit Information 0 0.5 0.5 1.0 49.96 Cost for Mailing 0 0 0 0 0.44

Totals 1.5 4 1.5 7 483.37 Assuming a single adverse effects repo rt submitted over three year period: Estimated Total Annual Respondent Burden: (1 event x 7 hours) ÷ 3 = 2.3 hours Estimated Total Annual Respondent Cost: (1 event x $483.37) ÷ 3 = $161

6(b) Total Annual Respondent Burden and Costs

Table 3 – Total Annual Respondent Burden/Cost

Per Submission Estimates Total Submissions TotalsMay 9, 2014

Page 13 of 16 Burden (hrs) Costs($) Expected each

year Burden (hrs) Costs ($)

CBI Substantiation 21.5 1,560 20 430 31,210

Adverse Effects Reporting 7 483 1/3 2.3 161 Totals 432.3 31,371

6(c) Estimating Agency Burden and Costs

The Agency will incur burden and costs while performing the various activities necessary to review CBI substantiation submissions and any adverse effects reports submitted for exempted plant-incorporated protectants. These activities are described in Section 5 of this ICR and may include the tracking and review of submissi ons, requests for additional information, or consultations with applicants. Tables 4 a nd 5 provide the average EPA burden and cost estimates for performing these activities.

Table 4 - Average Agency Burden and Cost Estimates per Submission for EPA Activities

related to CBI Substantiation

Burden Hours Total Activities Mgmt. ($120.60/hr) Tech. ($78.24/hr) Clerical ($44.61/hr) Burden (hrs) Costs ($) Consult With Registrant 1 3 0.5 4.5 377.63

Record Submissions 0 0.5 1 1.5 83.73

Review Submissions 1 2 0 3 277.08

Store the Information 0 0.5 1 1.5 83.73

Totals 2 6 2.5 10.5 822.18 Estimated Total Annual Agency Burden: 20 events x 10.5 hours = 210 hours Estimated Total Annual Agency Cost: 20 events x $822.18 = $16,444

Table 5 – Average Agency Burden and Cost Estimates per Submission for EPA Activities related to an Adverse Effects Report Submitted for an Exempt Plant-Incorporated Protectant

Activities Burden Hours Totals Mgmt. ($120.60/hr) Tech. ($78.24/hr) Clerical ($44.61/hr) Burden (hrs) Costs ($) Consult With Registrant 0.5 1 0.5 2 $160.85
Record Submissions 0 0.5 1 1.5 $83.73
Review Submissions 1 1 0 2 $198.84
Store the Information 0 0.5 0.5 1 $61.43 Totals 1.5 3 2 6.5 $504.85May 9, 2014

Page 14 of 16 Assuming a single adverse effects report might be submitted over the 3 year approval period for the ICR, the total annual average burden and costs for EPA activities related to the adverse effects report is calculated as follows:

Estimated Total Annual Agency Burden: (1 event x 6.5 hours) ÷ 3 = 2.2 hours Estimated Total Annual Agency Cost: (1 event x $504.85) ÷ 3 = $168

In addition, the Agency may determine that additional follow-up action is necessary for either type of submission and will be providi ng necessary guidance for these requirements.

Table 6 – Total Annual Agency Burden/Cost

Per Submission

Estimates Total Submissions Expected each year Totals

Burden

(hrs) Costs ($) Burden (hrs) Costs ($)

CBI

Substantiation 10.5 822 20 210 16,444

Adverse Effects Reporting 6.5 504 1/3 2.2 168

Totals 212.2 16,612

6(d) Bottom Line Burden and Cost Table

The following table presents the total estimat ed annual burden and costs for this ICR:

Table 7 – Total Annual Respondent and Agency Burden and Cost Estimates Respondent Agency Activities Burden (hrs) Costs ($) Burden (hrs) Costs ($)
CBI Substantiations 430 31,210 210 16,444 Adverse Effects Reports 2 161 2 168
Totals 432 31,371 212 16,612 Columns and Rows may not add due to rounding

6(e) Reasons for Change in Burden

There is increase of 43 hours in the total es timated respondent burden compared with the ICR currently approved by OMB. This increase reflects EPA's updating of burden estimates for this collection based upon histor ical information on the number of CBI substantiations per year. Based upon revised estimates, the number of CBI s ubstantiations per year has increased from 18 to 20, with a corresponding increase in the asso ciated burden. The estimated number of adverse effect reporting submissions remains the same. Th e increase in the expected number of responsesMay 9, 2014

Page 15 of 16 is primarily driven by an expected increase in the number of applications for registration requiring CBI substantiation. This change is an adjustment.

The total burden hours per response has not changed for this ICR renewal. However, because of the increase in CBI substantiations, the total annual burden estimate for registrants has increased by 43 hours from 389 to 432 hours, with a resultant increase in the annual costs for registrants from $26,875 to $31,371.

6(f) Burden Statement

The total annual “respondent” (appl icant) burden for the collection of information in this

renewal is estimated to be 432 hours. The a nnual respondent burden for the collection of

information associated with the substantiation at the time of submission for CBI claims related to a PIP registration application is estimated to average 21.5 hours per submission, and the annual respondent burden for the collection of informa tion associated with the reporting of adverse effects for exempted PIPs is estimated to average 7 hours per submission.

“Burden” is defined in 5 CFR 1320.3(b). The Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information subject to the PRA unless it displays a currently valid OMB control number. OMB control numbers for certain regulations in Title 40, after initial display in the Federal Register, are listed in 40 CFR part 9 and may appear on the information collection instrument as appli cable, i.e., form or instructions, and in the Federal Register.

The Agency has established a public docket for this ICR under Docket ID No. EPA-HQOPP-2013-0494, which is available for online viewing at http://www.regulations.gov , or in person viewing at the EPA Docket Center-Publi c Reading Room, EPA West Building, in Rm. S3334, 1301 Constitution Avenue, NW, Washington, DC. This docket facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excl uding federal holidays. The docket telephone number is (202) 566-1744. You may submit commen ts 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 collect ion 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, Wa shington, D.C. 20460. Include Docket ID No. EPA-HQ-OPP-2013-0494 and OMB control number 2070-0142 in any correspondence.

7. ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachments to the supporting statement are ava ilable in the public docket established for this

ICR under docket identification number EP A-HQ-OPP-2013-0494. These attachments are available for online viewing at http://www.regulations.gov or otherwise accessed as described in section 6(f) of the supporting statement.May 9, 2014

Page 16 of 16 Attachment A: 40 CFR part 174
- Procedures And Requirements For PlantIncorporated Protectants . Also available online at http://www.gpo.gov/fdsys/pkg/CFR- 2013-title40-vol25/pdf/CFR-2013- title40-vol25-part174.pdf

Attachment B 7 USC 136w(b) - FIFRA Section 25(b ). Available online athttp://www.gpo.gov/fdsys/pkg/USCODE-2012-title7/pdf/USCODE2012-title7-chap6-subchapII-sec136w.pdf

Attachment C : 7 USC 346a(a) - FFDCA Section 408(a) . Also available online athttp://www.gpo.gov/fdsys/pkg/USCODE-2012-title21/pdf/USCODE2012-title21-chap9-subchapIV-sec346a.pdf

Attachment D: Record of Consultations

Attachment E: Worksheets Used to Calculate Labor Costs

Attachment F: Display Related to OMB Control #2070-0142