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SUPPORTING STATEMENT 

FOR AN INFORMATION COLLECTION REQUEST (ICR) 

1. IDENTIFICATION OF THE INFORMATION COLLECTION 

1(a) Title: 

Plant-Incorporated Protectants; CBI Substantiation 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 Insecticide, Fungicide, and Rodenticide Act (FIFRA). 

Prior to EPA granting a registration, the manufacturer of the pesticide must demonstrate to the 

Agency that the use of the pesticide 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 tolerance or exemption from the requirement of a 

tolerance for pesticide residues on food or feed. 

The Agency promulgated a final rule (codified 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 substance.” 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) covers the two information collection related 

provisions contained in the rule, i.e., the provision that requires registrants that make 

Confidential Business Information (CBI) claims to substantiate such claims when they are made, 

and the provision that requires manufacturers of PIPs exempted from requirements of registration 

under the final rule to report adverse effects to the Agency. The current CBI regulations at 40 

CFR part 2 require that claimants substantiate their CBI claims for their own records when the 

claim is made, and subsequently provide the substantiation to EPA only if requested. The 

substantiation, however, is not required to be included with the submission to EPA in which the 

CBI claims are made. The burden associated with the existing requirement for CBI claims 

pursuant to 40 CFR part 2 is already approved by OMB under OMB Control No. 2020-0003. 

Although 40 CFR part 174 requires the claimant to include the CBI substantiation in the 

PIP- related submissions to EPA, it is difficult to identify any additional burden that such a 

requirement might actually impose. Nevertheless, the Agency has chosen the conservative 

approach of including potential burden and costs for preparing and submitting the CBI 

substantiation at the time of submission of the information containing the CBI claim as required 

by the rule. 
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The provisions of 40 CFR 174 that are related to information collection activities which 

are part of registration activities, e.g., data requirements for pesticide registrations, are already 

approved by OMB under the PRA, and that approval is not impacted by the clarification 

provided in the final rule. Information collection activities related to pesticide registration are 

approved under OMB Control Nos. 2070-0060 (Application 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 Permits (EUPs) for Pesticides). This ICR, 

therefore, discusses the paperwork 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 adverse 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 pesticides, 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 environment, 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 section 5 of FIFRA, or subject to an emergency 

exemption under section 18 of FIFRA. Pesticides that are "not registered" include pesticides that 

are exempt from FIFRA requirements under section 25(b) (Attachment B). 

FIFRA section 2(bb) defines the term "unreasonable 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 benefits 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 that Act (7 U.S.C. 136w(b)(2)). EPA 

interprets FIFRA section 25(b)(2) to authorize EPA to exempt a pesticide or category of 

pesticides that EPA determines poses a low probability of risk to the environment, and that is not 

likely to cause unreasonable adverse effects to the 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 pesticide. 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 animals, plants, water, air and land. Potential risks 

to humans include dietary risks as well as non-dietary risks such as those resulting from 
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occupational or residential exposure to the pesticide. 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 exemption criterion, whether the use of the 

pesticide is likely to cause unreasonable adverse effects on the environment even in the absence 

of regulatory oversight under FIFRA, EPA balances all the potential 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 environmental costs and benefits of the use of the 

pesticide. If the pesticide meets both exemption 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 tolerance for the residue and the residue is within the 

tolerance limits, or an exemption from the requirement 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 aggregate exposure to the pesticide chemical residue, 

including all anticipated dietary exposures and all other exposures for which there is reliable 

information” (21 U.S.C. 346a(c)(2)(A)). Section 408 of the FFDCA also directs EPA to 

specifically consider harm that may result to infants and children as a result of pesticide chemical 

residues. 

 A determination that a pesticide chemical meets 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 arising from other routes of exposure. However, 

FIFRA does not provide for exemption of a pesticide in food based solely upon consistency with 

the FFDCA section 408 exemption standard. At a minimum, EPA also must evaluate risks 

arising from occupational exposure to humans and determine that such risks meet both 

exemption criteria. In addition, EPA must evaluate 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 pesticide 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 protected from unauthorized disclosures. Since 

registrants are already required to ensure that CBI claims are proper 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. 
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The Agency’s analysis of the potential risks and 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 unforeseeable 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 reporting 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 applies 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 claims of confidentiality will be used by the 

Agency to determine whether CBI claims comply with the confidentiality provisions of FIFRA. 

Early substantiation of CBI claims will enable the Agency to promptly release information 

supporting PIPs registration decisions, without delaying registrations in order to obtain CBI 

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

CBI. 

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

adverse effects to determine if any additional regulatory actions are warranted. These reports will 

also enable the Agency to report to appropriate oversight bodies and the public its evaluation of 

such adverse effects and will help support any additional decision on regulatory oversight. 

3. NON DUPLICATION, CONSULTATIONS, 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 Protection Act (FPPA), and the U.S. Food and Drug 

Administration (FDA) which has responsibilities 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 consistency between programs, adopting consistent 

approaches, to the extent permitted by the respective statutory authorities. A consistent approach 

between agencies is easier for the regulated community to understand. 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 Inspection Service (APHIS) regulates field testing 
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of genetically altered plants, while EPA will have regulatory oversight of the pesticide 

substances produced by those plants. In instances where review under the FPPA may be 

triggered, the respondent will need to contact APHIS for a determination of whether the plant 

containing a PIP is a plant pest that will need a permit. In addition, registrants may be required 

to obtain an EUP for PIPs-related field trials. In such cases, registrants 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 covered in this ICR, i.e., the upfront CBI substantiation or the submission of adverse effects reports for exempted PIPs. Each 

respondent must submit information unique to his/her product application, or allegation received, 

and will do so only once on occasion. 

3(b) Public Notice Required Prior to ICR Submission to OMB 

 EPA published a notice in the Federal Register announcing a 60-day public notice and 

comment period on the draft ICR on September 25, 2013 (78 FR 59014). EPA received no public 

comment in response to this notice, which is available 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 published in the Federal Register concerning the 

renewal of this ICR, as required under 5 CFR 1320.8(d)(1) the Agency consulted with 

stakeholders who actively interact with the Agency through the use of this collection instrument. 

The consultation respondents who replied to EPA’s consultation request generally agreed that the 

burden estimate in the ICR were reasonable, and did not have specific suggestions for improving 

or clarifying the current collection. Therefore the Agency made no changes to the draft ICR 

based on the consultations. A record of the consultations (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 either in conjunction with the application or 

when an adverse effect occurs for an exempted PIP. This activity is conducted only once per 

"event," and therefore, there are no available 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), federal agencies are required to indicate 

whether the proposed collection of information involves the use of automated, electronic, 

mechanical, or other technological collection techniques or other forms of information 
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technology, e.g., permitting electronic submission of responses, and an explanation of the 

decision. At this time of this renewal, EPA’s Office of Pesticide 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 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. 

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 and will be protected from disclosure by the EPA 

under FIFRA section 10 and the associated regulations as contained in 40 CFR Part 2, Subpart B. 

When information that is claimed as trade secret or CBI is provided to the Agency, such 

information is subject to the protections and procedures set forth in FIFRA Section 10. Nothing 

in this rule affects those protections. 

Even if a registrant fails to include the required 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 FIFRA Confidential Business Information Security 

Manual. This manual contains instructions relative to all contact with confidential documents, 

including responsibility of EPA employees, physical security measures, CBI materials within 

EPA, CBI typing procedures (documents typed internally or by contract), and interdivisional 

routing procedures. The manual dictates 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 placed 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 information 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 collection activities contained in this ICR include 

producers and importers of PIPs. These entities may be classified under the following North 

American Industrial Classification System (NAICS) codes: 

32532 Pesticides and Other Agricultural Chemical Manufacturing 
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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 Florists’ Supplies (Wholesalers) 

4(b) Information Requested 

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

Registrants must continue to review the regulations 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 addressed 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 registration requirements must submit to EPA any 

information they subsequently obtain regarding 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 during 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 business but rather envisions these effects being discovered from 

ongoing studies of various PIPs or customer complaints. Although EPA specifies 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 respond to Agency questions that arise based on 

the submission, whether it be the CBI substantiation, 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 additional Agency requirement would come in the 

form of a data call-in covered 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 substantiation 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 part 
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2. The adverse effects reporting occurs when an entity obtains information regarding adverse 

effects on human health or the environment alleged to have been caused by the exempted PIP. 

Although each activity is distinct, a typical respondent for each activity is expected to 

engage in the following activities: 

Activity Explanation 

Read Regulations The respondent needs to become familiar with the regulations governing 

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

Plan Activities The respondent must develop/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 provide 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 adverse 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 that 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 questions either in writing, or 

verbally via meetings or by telephone, 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 adverse effects report for allegations 

related to an exempted PIP, the submission is recorded or logged in 

by the Agency to document its receipt. The Agency will create an 
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electronic record of the necessary information for routing and 

tracking purposes. 

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

evaluate the CBI substantiations 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 providing substantiation of CBI claims at the time the claims are 

made must necessarily submit the information as part 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 claims are currently submitted by mail. EPA is working to allow 

electronic submission of registration 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 pertaining to CBI substantiation or adverse 

effects for exempted PIPs will be routed to the Biopesticide and Pollution 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 Manager 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 review. 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 marked as such. The Agency will continue current 

practice of treating information claimed 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 claimed as CBI, does not qualify 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 package will then be processed accordingly. 

For adverse effects reports related to exempted PIPs, a file will be created and the report 

will be forwarded to the appropriate product Manager within BPPD. The Manager assures that 

the initial OPPIN entry is correct, reviews the information, and determines the appropriate 

review and next steps based on the contents of the report, routing the report through scientific 
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and/or administrative review, as appropriate. If an adverse effect report indicates that additional 

action is warranted or necessary, the Agency will take appropriate action. 

5(c) Small Entity Flexibility 

In promulgating the requirements codified 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 entity, regardless of size, is already 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 submission 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 ensure that only the person who produces the 

exempted PIP for sale and distribution is responsible for adverse effects reporting, and only if 

they obtain the adverse effects information. The Agency has designed such reporting to be 

minimal and has placed the burden on the Agency to take additional action beyond the entity 

making the report. 

5(d) Collection Schedule 

The CBI substantiation occurs only upon submission of claims of confidentiality and the 

adverse effects reporting only occurs on occasion. There is no collection schedule per se 

associated with these collection activities. These activities are conducted once per submission. 

6. ESTIMATING THE BURDEN AND 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 substantiation and the adverse effects reports. The burden 

estimates are based on the Agency’s experience regarding existing burden estimates related to 

CBI substantiation and adverse effects reporting for conventional pesticides, 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 estimates 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 + 
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benefits), and the Fully loaded wage rate (loaded wage rate + overhead). Fully loaded wage 

rates are used to calculate the 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 Industry-Specific Occupational Employment and Wage Estimates from 

the Bureau of Labor Statistics (BLS) at http://www.bls.gov/oes/current/oes_nat.htm. 

 Sectors: The specific North American Industry Classification System (NAICS) code and 

website for each sector is included in that sector’s wage rate table. Within each sector, the wage 

data are provided by Standard Occupational Classification (SOC). The SOC system is used by 

Federal statistical agencies to classify workers into occupational categories for the purpose of 

collecting, calculating, or disseminating data (see http://www.bls.gov/oes/current/oes_stru.htm ). 

 Loaded Wage Rate: Unless stated otherwise, all benefits represent 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 sectors are listed for which 

44% 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. Attachment E contains worksheets providing the breakout of these 

costs. Costs are indexed to 2012 data. 

To derive the labor rates for this ICR, Agency economists estimated the wages for the 

management, technical, and clerical labor categories using the methodology described in 

Attachment E. The respondent costs for this renewal for managerial, technical and clerical rates 

are estimated at $117.74, $62.58, and $37.33 per hour, respectively. 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 additional costs related to the transmittal of this 

information to the Agency. The costs for submitting the registration application package are 

already included under other existing ICRs. These 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 registrants will claim as CBI which will need to be 

substantiated. It is likely that registrants will recognize, 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 that no more than 60 PIP-related registration 

applications with associated CBI substantiations will be submitted over the three-year approval 

period for this ICR, or 20 per year. This estimate 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, which was 16 applications in 2012. 
May 9, 2014 

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Table 1 – Average Respondent Burden and Cost Estimates per Submission for 

Substantiation of CBI Claims Made in a Plant-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 adverse effect reports to be submitted for 

exempted PIPs, this ICR includes an estimate of one such report being submitted over the threeyear approval period for this ICR. The per-submission estimate is therefore divided by 3 to 

provide an average annual burden and cost to include in the total annual estimates for this ICR. 

The total annual average burden and costs for the adverse 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 report 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 Totals 
May 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 submissions, requests for additional information, or 

consultations with applicants. Tables 4 and 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 $504.85 

 
May 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 providing 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 estimated 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 estimated respondent burden compared with the 

ICR currently approved by OMB. This increase reflects EPA's updating of burden estimates for 

this collection based upon historical information on the number of CBI substantiations per year. 

Based upon revised estimates, the number of CBI substantiations per year has increased from 18 

to 20, with a corresponding increase in the associated burden. The estimated number of adverse 

effect reporting submissions remains the same. The increase in the expected number of responses 
May 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” (applicant) burden for the collection of information in this 

renewal is estimated to be 432 hours. The annual 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 information 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 applicable, 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-Public 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, 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-2013-0494 and OMB control number 2070-0142 in any correspondence. 

7. ATTACHMENTS TO THE SUPPORTING STATEMENT 

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

ICR under docket identification number EPA-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 at 

http://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 at 

http://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