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SUPPORTING STATEMENT

FOR AN INFORMATION COLLECTION REQUEST (ICR)

1. IDENTIFICATION OF THE INFORMATION COLLECTION 

1(a) Title of the Information Collection: Plant-Incorporated Protectants; CBI 

Substantiation and Adverse Effects Reporting

OMB No.: 2070-0142 EPA ICR No.: 1693.06

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 new 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 is already approved 

by OMB. 

Although 40 CFR 174 requires the claimant to include the CBI substantiation in the PIPrelated 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 (Application for Experimental Use Permit (EUP) to Ship and Use a 

Pesticide for Experimental Purposes Only). 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 most 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 experimental use permit (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 up-front 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 

In preparing to renew this ICR, EPA published a notice in the Federal Register which 

provided a 60-day public notice and comment period on the draft ICR (see 72 FR 11862; March

14, 2007). EPA did not receive comment in response to this notice.

3(c) Consultations 

In developing its approach to PIPs, EPA requested advice from two scientific advisory

groups at three meetings. In 1992, a subpanel of the FIFRA Scientific Advisory Panel (SAP) 

reviewed a draft proposed policy statement and answered a series of scientific questions 

concerned primarily with EPA’s proposed exemptions under FIFRA. The following year, a 

Subcommittee of the EPA Biotechnology Science Advisory Committee (BSAC) met to address a 

series of scientific questions concerned primarily with EPA’s proposed exemptions under the 

FFDCA. In 1994, a joint meeting of these two groups met to address a series of scientific 

questions on approaches to PIPs under both FIFRA and FFDCA. Advice from these scientific 

advisory groups was considered in developing the provisions codified at 40 CFR 174. 

In addition to the public consultation described above, consultation and/or dialogue 

between industry and managers in the Biopesticides and Pollution Prevention Division (BPPD) 

of the Office of Pesticide Programs (OPP) occurs on an informal, on-going, as-needed basis, 

during the submission and review of an application for EUP or registration. Experience has 

shown that if any sort of problem arises, be it technical, administrative, or otherwise, or, if there 

are suggestions for improvements in the program, the applicants will not hesitate to inform 

BPPD. Any questions or consultations connected with a particular submission are addressed in a 

meeting or telephone conversation with the applicant, and do not necessarily occur at specified 

intervals. 

In addition to the informal consultations above, EPA will publish a notice in the Federal 

Register concerning the renewal of this ICR. The Agency will consult with stakeholders who 

actively interact with the Agency through the use of this collection instrument and will solicit 

stakeholder assessment of the regulatory burden estimates expressed by the Agency in this ICR.
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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.. 

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: 
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32532 Pesticides and Other Agricultural Chemical Manufacturing

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 

(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 a 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 ICR (Data Call-Ins: Special 

Review and Registration Review; OMB Control No. 2070-0057; EPA ICR No. 922). This ICR 

is not intended to address such activities.

(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 
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is submitting PIP related information to EPA that contains CBI claims pursuant to 40 CFR part 

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: 

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 the Office of Pesticide 

Programs as required.

Store, Maintain, 

and File 

Information

The final rule does not contain any new 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. Since no new recordkeeping 

requirements were imposed by this rule, EPA did not include any related 

burden in this ICR. 

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: 

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 it is parts of that package that are claimed as CBI. Although EPA is 

working to allow electronic submission of registration packages, they are currently submitted by 

mail.

All information received by the Agency pertaining to CBI substantiation or adverse 

effects for exempted PIPs will be routed to the Biopesticides and Pollution Prevention Division 

(BPPD) of the Office of Pesticide Programs (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 

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 
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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 Respondent Burden 

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. 

For purposes of this ICR, EPA is assuming that no more than 54 PIP-related registration 

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

period for this ICR, or 18 per year. This estimate is based on the average number of submissions 

with CBI per year over the last two years. Based on the number of EUP applications over the 

last two years, EPA estimates 6 EUP applications per year, each of which requires a CBI list of 

EUP cooperators. Based on the number of PIP applications over the last two years, EPA 

estimates that there may be up to 12 new PIP applications each year, each of which may contain 

CBI. 

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. Tech. Clerical Burden Costs
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($109.82/hr) ($60.39/hr) ($35.89/hr) (hrs) ($)

Read Regulations 1 2 0 3 230.60 

Plan Activities 2 4 0 6 461.19 

Gather Information 0 4 0 4 241.56 

Review Information 2 1 1 4 315.92 

Complete Paperwork 0 1 2 3 132.17 

Submit Information 0.5 0.5 0.5 1.5 103.05 

Totals 5.5 12.5 3.5 21.5 1,484.48 

Estimated Total Annual Respondent Burden: 18 events x 21.5 hours = 387 hours

Estimated Total Annual Respondent Cost: 18 events x $1,484.48 = $26,721

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.

($109.82/hr)

Tech.

($60.39/hr)

Clerical

($35.89/hr)

Burden 

(hrs)

Costs

($)

Read Regulations 0.5 1 0 1.5 115.30 

Plan Activities 0.5 0.5 0 1 85.10

Gather Information 0 1 0 1 60.39 

Review Information 0.5 0.5 0 1 85.10 

Complete Paperwork 0 0.5 1 1.5 66.08 

Submit Information 0 0.5 0.5 1.0 48.14 

Cost for Mailing 0 0 0 0 0.44 

Totals 1.5 4 1.5 7 60.56 

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 $460.56) ÷ 3 = $154

6(b) Estimating Respondent Costs 

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, state government, 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 + 

benefits), and the Fully loaded wage rate (loaded wage rate + overhead). Fully loaded wage 

rates are used to calculate the Agency’s staffing costs. 
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Unloaded Wage Rate: Wages are estimated for labor types (management, technical, and 

clerical) within applicable sectors. The Agency uses average wage data for the relevant sectors 

available in the National Industry-Specific Occupational Employment and Wage Estimates from 

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

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

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

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

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

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

Loaded Wage Rate: Unless stated otherwise, all benefits represent 43% of unloaded wage 

rates, based on benefits for all civilian non-farm workers, from

http://www.bls.gov/news.release/ecec.t01.htm. However, if other sectors are listed for which 

43% is not applicable; the applicable percentage will be stated.

Fully Loaded Wage Rate: We multiply the loaded wage rate by 50% (EPA guidelines 20-

70%) to get overhead costs. Attachments F and F.1 contain worksheets providing the breakout 

of these costs. Costs are indexed to 2008 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 $109.82, $60.39, and $35.89 per hour, respectively. These labor rates are fully

loaded and 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 the 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.

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 3 and 4 provide the average EPA burden and cost 

estimates for performing these activities.
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Table 3 - Average Burden and Cost Estimates per Submission for EPA Activities related 

to CBI Substantiation 

Burden and Cost Estimates Totals

Activities Mgmt.

($107.56/hr)

Tech.

($71.58/hr)

Clerical

($41.21/hr)

Burden 

(hrs)

Costs

($)

Consult With Registrant 1 3 0.5 4.5 342.91

Record Submissions 0 0.5 1 1.5 77.00

Review Submissions 1 2 0 3 250.73

Store the Information 0 0.5 1 1.5 77.00

Totals 2 6 2.5 10.5 747.64

Estimated Total Annual Agency Burden: 18 events x 10.5 hours = 189 hours

Estimated Total Annual Agency Cost: 18 events x $747.64 = $13,457.

Table 4 - Average Burden and Cost Estimates per Submission for EPA Activities related to an 

Adverse Effects Report Submitted for an Exempt Plant-Incorporated Protectant

Activities Burden and Cost Estimates Totals

Mgmt.

($107.56/hr)

Tech.

($71.58/hr)

Clerical

($41.21/hr)

Burden

(hrs)

Costs

($)

Consult With Registrant 0.5 1 0.5 2 145.97 

Record Submissions 0 0.5 1 1.5 77.00 

Review Submissions 1 1 0 2 179.14 

Store the Information 0 0.5 0.5 1 56.40 

Totals 1.5 3 2 6.5 458.50 

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 $458.50) ÷ 3 = $153

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. 

6(d) Bottom Line Burden and Cost Table

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

Table 5 – Total Annual Burden and Cost Estimates

Respondent Agency

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

CBI Substantiations 387 26,721 189 13,457 

Adverse Effects Reports 2 154 2 153 
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Totals 389 26,875 191 13,610 

Columns and Rows may not add due to rounding

6(e) Reasons for Change in Burden 

The expected number of responses requiring CBI substantiation has increased from 14 in 

the last ICR approval to 18 for this ICR renewal. The number of adverse effect reporting

submissions remains the same. The increase in the expected number of responses is primarily

driven by an expected increase in the number of applications for experimental use permits 

requiring CBI substantiation. 

The total burden hours per respondent has not changed for this ICR renewal. However, 

because of the increase in CBI substantiations, the total annual burden estimate has increased 

from 303 to 389 hours. The annual costs have also increased from $20,879 to $26,875. The 

increase in CBI substantiations is the primary reason for the increase in costs, although part of 

the cost increase is due to the rise in labor cost when indexed to 2008 dollars. The annual burden 

increase represents an adjustment.

6(f) Burden Statement 

The total annual respondent burden for the collection of information contained in this 

ICR is estimated to be 389 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. 

As defined by the PRA and 5 CFR 1320.3(b), “burden” means the total time, effort, or 

financial resources expended by persons to generate, maintain, retain, or disclose or provide 

information to or for a Federal agency. This includes the time needed to review instructions; 

develop, acquire, install, and utilize technology and systems for the purpose of collecting, 

validating, and verifying information, processing and maintaining information, and disclosing

and providing information; adjust the existing ways to comply with any previously applicable 

instructions and requirements; 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. An Agency may not conduct or sponsor, and a 

person is not required to respond to, a collection of information unless it displays a currently

valid OMB control number. The OMB control numbers for EPA’s regulations in title 40 of the 

CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the 

related collection instrument or form, if applicable. 

The Agency has established a public docket for this ICR under Docket ID No. EPA-HQOPP-2010-0281, which is available for online viewing at www.regulations.gov, or in person 

viewing at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South 

Building), 2777 S. Crystal Drive, Arlington, VA. This docket facility is open from 8:30 a.m. to 4 

p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 
March 30, 2010

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305-5805. 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.

Submit your comments, referencing Docket ID No. EPA-HQ-OPP-2010-0281 and OMB 

Control No. 2070-0142, to (1) EPA online using www.regulations.gov (our preferred method), or 

by mail to: Public Information and Records Integrity Branch (PIRIB), Mail Code: 7502P, Office 

of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, 

Washington, DC 20460, and (2) OMB by mail to: Office of Information and Regulatory Affairs, 

Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, 

NW, Washington, DC 20503.

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-2010-0281. These attachments are 

available for online viewing at www.regulations.gov or otherwise accessed as described in 

section 6(f) of the supporting statement.

Attachment A: 40 CFR part 174 - Procedures And Requirements For PlantIncorporated Protectants. Available online at the National Archives and 

Records Administration’s Electronic CFR Webpage

Attachment B 7 USC 136w(b) - FIFRA Section 25(b). Available online at the US House 

of Representatives’ Office of the Law Revision Counsel’s US Code 

website

Attachment C: 7 USC 346a(a) - FFDCA Section 408(a). Available online at the US 

House of Representatives’ Office of the Law Revision Counsel’s US Code 

website

Attachment D: Record of Consultations - Reserved

Attachment E: Worksheet for Estimating OPP ICR Wage Rates for Industry, State 

and EPA Labor Costs; See attachment below

Attachment F: Display Related to OMB Control #2070-0142 -Reserved
March 30, 2010

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March 30, 2010

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Attachment E

Work Sheets used to Calculate Registrant Labor Costs 

This attachment is available as part of the electronic docket EPA-HQ-OPP-2010-0281 and is 

part of the ICR’s Supporting Statement.

NAICS: 325300

Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing

Labor Category: Formula Managerial Technical Clerical

Unloaded Hourly Rate1= W $51.01 $28.05 $16.67 

Benefits Percentage2Lb = B/W 44% 44% 44%

Benefits per hour B = W*Lb $22.20 $12.21 $7.26 

Loaded Hourly Rate Wb = W + B = 

W(1+Lb)

$73.21 $40.26 $23.93 

Overhead Percentage3Lo = OH/Wb 50% 50% 50%

Overhead per hour OH = Wb*Lo $36.61 $20.13 $11.96 

Fully Loaded Hourly

Rate

Wf = Wb + OH

= W + B + OH 

$109.82 $60.39 $35.89 

1. Data Source: BLS http://www.bls.gov/oes/current/naics4_325300.htm May 2008 data

 NAICS 325300 - Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing

 Standard Occupational Codes: 

 Management: 11-0000, Management Occupations 

 Technical: 19-0000, Life, Physical, and Social Science Occupations 

 Clerical: 43-0000, Office and Administrative Support Occupations 

2. Fringe benefits/wage per hour. 

3. U. S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth 

Edition, EPA-452-02-001, January 2002, pg. 2-34. The loading for indirect costs is within the 

range of 20-70% of the load labor rate (wage + benefits) suggested in EPA guidance.
March 30, 2010

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Attachment E.1

Work Sheets used to Calculate EPA and Federal Government Labor Costs

This attachment is available as part of the electronic docket EPA-HQ-OPP-2010-0281 and is 

part of the ICR’s Supporting Statement

NAICS: 999100 

Federal Executive Branch

Labor Category: Formula Managerial Technical Clerical

Unloaded Hourly Rate1= W $49.96 $33.25 $19.14 

Benefits Percentage2Lb = B/W 44% 44% 44%

Benefits per hour B = W*Lb $21.75 $14.47 $8.33 

Loaded Hourly Rate Wb = W + B = 

W(1+Lb)

$71.71 $47.72 $27.47 

Overhead Percentage3Lo = OH/Wb 50% 50% 50%

Overhead per hour OH = Wb*Lo $35.85 $23.86 $13.74 

Fully Loaded Hourly

Rate

Wf = Wb + OH

= W + B + OH 

$107.56 $71.58 $41.21 

1. Data Source: BLS http://www.bls.gov/oes/current/naics4_999100.htm May 2008 data

 NAICS 999100 - Federal Executive Branch

 Standard Occupational Codes: 

 Management: 11-0000, Management Occupations 

 Technical: 19-0000, Life, Physical, and Social Science Occupations 

 Clerical: 43-0000, Office and Administrative Support Occupations

2. Fringe benefits/wage per hour. 

3. U. S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth 

Edition, EPA-452-02-001, January 2002, pg. 2-34. The loading for indirect costs is within the 

range of 20-70% of the load labor rate (wage + benefits) suggested in EPA guidance.