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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

Submission of Protocols and Study Reports for Environmental Research Involving 

Human Subjects

OMB No. 2070-0169 EPA No. 2195.04

1(b) Short Characterization/Abstract

The Environmental Protection Agency (EPA or the Agency) is responsible for the 

regulation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

and the Federal Food, Drug, and Cosmetic Act (FFDCA). The applicable Sections of FIFRA and 

FFDCA which authorize the information collection activities in this ICR are discussed in Section 

2(a) of this document. In January 2006, EPA issued a final rule to amend the Federal Policy for 

the Protection of Human Subjects (also known as the Common Rule) at 40 CFR part 26 (see 

Attachment A). EPA’s January 2006 final rule significantly strengthens and expands the 

protections for subjects of “third-party” human research (i.e., research that is not conducted or 

supported by EPA). In addition to other protections, the final rule requires affected entities to 

submit information to EPA and an institutional review board (IRB) prior to initiating, and to 

EPA upon the completion of, certain studies that involve human research participants. 

The information collection activity imposed by this final rule consists of activity-driven 

reporting and recordkeeping requirements for those who intend to conduct research for 

submission to EPA under the pesticide laws. If such research involves intentional dosing of 

human subjects, these individuals (respondents) are required to submit study protocols to EPA 

and a cognizant local Human Subjects IRB before such research is initiated so that the scientific 

design and ethical standards that will be employed during the proposed study may be reviewed 

and approved. In addition, respondents are required to submit information about the ethical 

conduct of completed research that involved human subjects when such research is submitted to 

EPA. This renewal ICR estimates the third party response burden from complying with the 

January 2006 final rule requirements. Information is typically submitted by registrants of 

pesticide products to support the registration of their products. It is estimated that the annual 

response burden is approximately 20,572 hours valued at about $1,712,833.

2. NEED FOR AND USE OF THE COLLECTION

2(a) Need/Authority for the Collection

The 2006 Appropriations Act, Pub. L. No. 109-54, required EPA to issue a final rule

addressing third-party intentional dosing human toxicity studies for pesticides, and EPA conduct 
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of intentional dosing human toxicity studies for pesticides. This ICR applies to all of the 

information collection activities identified in the final rule EPA promulgated in response to the 

Congressional mandate. EPA’s statutory authority to require and collect information identified 

in the final rule already existed under FIFRA and FFDCA.

 Sections 3(c)(5), 3(g) and 4(g)(2)(D) of FIFRA generally require EPA to determine that 

a pesticide would not present any “unreasonable adverse effects on the environment”

1 when 

deciding to grant a new or amended pesticide registration or to continue an existing registration. 

Section 4(g)(2)(E) of FIFRA and section 408(b)(2)(A)(ii) of FFDCA generally require EPA to 

determine that that there is a reasonable certainty that no harm will result from aggregate 

exposure to the residue of a pesticide chemical, including all anticipated dietary exposures and 

all other exposures for which there is reliable information when making pesticide tolerance 

decisions. FIFRA section 12(a)(2)(P) forbids any person “to use any pesticide in tests on human 

beings unless such human beings (i) are fully informed of the nature and purposes of the test and 

of any physical and mental health consequences which are reasonably foreseeable from, and (ii)

freely volunteer to participate in the test.” EPA established this collection of information as part 

of the final rule as authorized under section 25 of FIFRA and section 408(e)(1)(C) of FFDCA to:

(1) ensure that sound and appropriate scientific data are available to EPA when 

making regulatory decisions about pesticides as described in the previous 

paragraph; and,

(2) protect the interests, rights and safety of human research subjects, as required 

under FIFRA section 12(a)(2)(P).

Sections 3(c)(5), 3(g), 4(g)(2), and 25 of FIFRA, and sections 408(b)(2)(A)(ii) and 408(e)(1)(C) 

of FFDCA are included as Supporting Statement attachments B and C, respectively.

2(b) Practical Utility/Users of the Data

In order to ensure the availability of sound and appropriate scientific data in its decisions, 

and to protect the interests, rights and safety of human research subjects, EPA extended the 

requirements of the Agency’s Common Rule, 40 CFR Part 26, prospectively to third-party

research intended for submission to EPA under the pesticide laws and involving intentional 

exposure of non-pregnant, non-nursing adult human subjects. The information provided allows 

EPA to review protocols and related information before research involving human subjects is 

initiated, after it has been reviewed and approved by a local IRB. In addition, anyone who 

submits to EPA a report of research with human subjects must submit concurrently 

documentation of the ethical conduct of the research. This information collection activity allows 

EPA to ensure all human subjects in research conducted by EPA (first party), conducted by 

 

1 Defined at FIFRA section 2(bb) as “. . . (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 (21 U.S.C. 346a) . . . .”
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entities with support from EPA (second parties), or conducted by third parties with the intention 

to submit it to EPA are treated ethically.

3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION 

CRITERIA

3(a) Non duplication

The information requirements identified in the final rule do not duplicate other federal 

agency information collections. Other federal agencies have adopted the Common Rule and 

FDA has established requirements similar to those in the Common Rule for third-party 

researchers who perform human testing intended for submission to FDA. None of those 

requirements, however, apply to third-party research that is intended for submission to EPA.

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

Pursuant to 5 CFR 1320.8(d), EPA is publishing a Federal Register (FR) notice soliciting 

comment on this information collection activity and the Agency’s intent to renew the OMB 

approval of this ICR. The FR notice and the proposed renewal ICR as well as any public 

comment are located in the docket for this action, which can be accessed at 

http://www.regulations.gov using the docket identifier EPA-HQ-OPP-2011-0704.

3(c) Consultations

During preparation of this ICR renewal, EPA staff will contact respondent representatives 

to seek feedback on the burden estimates in the ICR and the clarity of guidance provided. Their 

responses to EPA’s consultation efforts will be summarized and made publicly available with the 

final ICR renewal request, as Attachment D.

3(d) Effects of Less Frequent Collection

Not applicable. This is an event-driven information collection activity and is conducted 

only as information is submitted to EPA for consideration. As such there is no set collection 

frequency for the collection of this information.

3(e) General Guidelines

The only guideline established under the Paperwork Reduction Act (PRA) that may be 

exceeded in this collection is the time period for retaining records. EPA’s requirement at 40 

CFR 169.2(k) states that records containing research data relating to registered pesticides be 

retained for as long as the registration is valid and the producer remains in business. 

Registrations are valid until they are either voluntarily canceled or withdrawn by the registrant or 

until EPA has cause to suspend or cancel the registration. 
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Since the average period of marketability of a pesticide ranges from 15 to 30 years, the 

PRA guidelines specifying that data other than health, medical or tax records not be required to 

be retained for more than three years will be exceeded in this collection activity. This is an 

existing requirement that was not changed by the final rule. In any case, EPA asserts that 

recordkeeping requirement merely codifies the usual and customary business practices of IRBs 

and third-party researchers; therefore no burden is attributed to the activity.

OMB regulations require agencies to provide a statement indicating whether the

collection of information involves the use of automated, electronic, mechanical, or other 

technological collection techniques or other forms of information technology, e.g., permitting 

electronic submission of responses, and an explanation of the decision (5 CFR

1320.5(a)(iii)(E)). EPA is not offering a fully electronic submission option at this time. EPA is 

developing an internet portal that would adequately secure any confidential and/or sensitive 

information submitted electronically; however, EPA is not yet ready to accept such information 

in this way.

Respondents that submit study protocols and/or reports to EPA may elect to submit 

certain information “electronically” via compact disc. Ordinarily, registrants would be required 

to submit 3 paper copies of study data to EPA. Under this hybrid option, registrants need only

submit 2 paper copies if they submit the required study data in Adobe Acrobat Portable 

Document Format (PDF) on a compact disc. 

Once EPA staff have become familiar with the electronic submission process and the 

technology, OPP believes that this option will allow the Agency to achieve operating efficiencies 

in the regulation of pesticides through the promotion and facilitation of the electronic submission 

process, including the delivery, review, data interchange capability and archiving of data 

supporting national pesticide registration. OPP expects that registrants will spend less time and 

money preparing copies and sending their submissions using the hybrid paper-electronic 

submission option, and stand to benefit from the efficiencies that EPA expects to experience 

during data reviews.

3(f) Confidentiality

EPA has implemented procedures to protect any confidential, trade secret or proprietary

information from disclosure that provide strict instructions regarding access to and contact with 

documents confidential business information (CBI). These procedures comply with EPA’s CBI 

regulations at 40 CFR Part 2, Subpart B.

3(g) Sensitive Questions

This information collection activity complies with the provisions of the Privacy Act of 

1974 and OMB Circular A-108. No information of a sensitive or private nature is requested in 

conjunction with this information collection activity. The protection of human research subjects’ 

privacy is a basic, long-standing principle within the scientific community. Reports of human 

research submitted to federal agencies should not identify subjects by name, or include 

recognizable photographs, or otherwise identify them. On the rare occasion that the Agency
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receives identifying information, such information will be treated as confidential and not 

released to third parties unless required by law.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a) Respondents/NAICS Codes

This collection of information applies to any entity that submits protocols and study

reports for environmental research involving human subjects under FIFRA and/or FFDCA. 

Although EPA has only received such third-party research in conjunction with FIFRA from 

pesticide registrants, it is conceivable that other entities could submit such information to EPA 

under FIFRA and/or FFDCA in the future. The North American Industrial Classification System 

(NAICS) code for the principal respondents to this ICR is 541710 (Research and Development in 

the Physical, Engineering, Life Sciences).

4(b) Information Requested

(i) Data items, including record keeping requirements

The final rule sets forth those additional information activities that are necessary to 

ensure the protection of human subjects of research when such research is submitted to EPA for 

consideration under FIFRA and/or FFDCA. 

(ii) Respondent Activities

The following information activities are required:

 Rule Familiarization and Training - read, and understand what data are to be submitted 

and understand the protocols must be developed to comply with the Common Rule.

 Submit Protocol to an IRB and EPA – Prepare and submit a proposal for test protocol to 

IRB for review. After approval by the IRB, submit the proposal and related 

documentation, including a record of the IRB approval, to EPA.

 Prepare and Submit Ethics Information for EPA Review - once a study is conducted, 

compile applicable records to document ethical conduct of the research.

 Store, File and Maintain Information – ensure that research information is placed in 

central records as required by FIFRA and consistent with section 3(e) of this ICR.

5. THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION 

METHODOLOGY, AND INFORMATION MANAGEMENT
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5(a) Agency Activities

EPA’s information-related activities associated with this collection consist of the 

following:

 Conduct Prior review on study protocol – review and comment on study protocol, 

document comments/review.

 Review Ethical Aspect of a Protocol and Study Report – make formal EPA determination 

on usefulness and ethical aspects of the study.

 Record and Report Information – Document any formal decisions made.

 Store, File and Maintain Information – compile information into appropriate databases 

and archive. 

5(b) Collection Methodology and Management

OPP completed a major review of its information tracking systems to improve their 

efficiency and accuracy. This review resulted in the development of a new integrated information 

system, which, when complete, will improve the quality of the Agency's databases and allows 

the EPA to respond more timely and accurately to queries from registrants and the public, 

including requests made under the FOIA.

OPP is also investigating the possibility of providing optional electronic data transfer 

services to the industry as a means of minimizing the burden of registration activities. The 

Agency's pesticide program, along with the pesticide industry, recognizes the advantages in 

terms of accuracy, speed, cost and personnel from electronic data transfer technologies. In 

addition, OPP is consulting with industry associations and other federal agencies, and 

participating in an Agency-wide workgroup to develop electronic reporting standards intended to 

facilitate collection of information from industry. 

OPP does not publish the studies submitted. However, it maintains records of each study 

in the Office of Pesticide Programs Information Network (OPPIN), and provides public access to 

OPPIN bibliographies through the National Pesticides Information Retrieval System (NPIRS). 

NPIRS supports searches of the PDMS database by chemical, subject, submission date, 

laboratory, guideline number, and document type, and the public may request copies of studies 

that are non-confidential by submitting a FOIA request.

5(c) Small Entity Flexibility

Although the Agency cannot predict whether or how many small entities might engage in 

the subject matter research, the burden and related cost for researchers to comply with these 

information collection activities is estimated to be a comparatively small portion of the overall 

cost of performing such studies. After reviewing the history of EPA’s consideration on human 

research in its various program offices, EPA estimates that only a limited number of third-party
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human studies will be impacted by these activities each year. Because both the number of 

affected studies is relatively small and the estimated current costs of compliance with the 

Common Rule are low, the potential overall burden and costs from these activities to third parties 

are also estimated to be small, regardless of their size. As a result, EPA has not provided any

special flexibility for small entities.

5(d) Collection Schedule

A periodic collection schedule is not appropriate for the information collection activity. 

The information collection activity is initiated by the respondents and therefore EPA expects that 

respondents will engage in the activities described in this ICR only once, whenever developing 

and performing a given research study that involves human subjects as governed by EPA’s 

regulations.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a) Estimating Respondent Burden

EPA is estimating only the incremental burden imposed upon respondents for compliance 

with the paperwork requirements established in the final rule. EPA is neither estimating, de 

novo, the estimated paperwork burden for compliance with the 1991 Common Rule in this ICR 

nor the paperwork burden associated with the generation of certain study data that is already 

covered by other ICRs, such as those requested by EPA in a Data Call-In under FIFRA section 

3(c)(2)(B). EPA does assume that IRBs are already in compliance with the 1991 Common Rule 

requirements and therefore believes that there is no additional burden imposed upon IRBs for 

compliance with the paperwork requirements established in the final rule and discussed in this 

document.

Based upon responses received in previous years to the Agency’s consultation questions, 

as well as historical data, EPA anticipates that respondents will submit to OPP an average of 34 

pesticide research studies per year under FIFRA and/or FFDCA that will involve intentional 

exposure of human subjects. See Attachment E for an explanation of the methodology, data, and 

assumptions used to calculate and revise previous estimates of respondent burdens and costs.

EPA also expects to receive other types of pesticide research involving human subjects; 

an average of 20 studies annually. While EPA assumes that researchers conducting these studies 

would already be required to comply with the 1991 Common Rule requirements, they will be 

subject to some additional paperwork requirements under EPA’s amendments. Therefore, EPA 

is estimating only the burden and costs associated with the paperwork activities that are 

described in the final rule.

Respondent activities that are within the scope of this ICR include: preparing and 

submitting protocols, supporting documents, and completed study reports for IRB, EPA, and 

HSRB review; communicating with IRB and EPA staff regarding required changes to a protocol; 

communicating with EPA about HSRB recommendations; and documenting protocol changes 
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made at the recommendation of an IRB, EPA, or the HSRB. Activities which are unrelated to 

the paperwork and recordkeeping requirements of the final rule, such as the costs of conducting 

the research, are not incremental paperwork or recordkeeping costs and therefore are not within 

the scope of this ICR.

The consultation responses indicated that EPA’s previous estimates significantly

underestimated the actual burden and costs. Thus, to calculate new burden and cost estimates for 

this renewal ICR, EPA relied upon the figures provided in the five consultation responses. Two 

of the five participants in the consultation process were also the two parties that submitted 

comments during the public comment period; the input they provided in their public comments 

was essentially the same as that included in the consultation responses. EPA calculated a 

weighted average of the estimates contained in each of the responses, to account for the fact that 

some study types are more complex than others. 

As shown in Tables 1 and 2, the total annual estimated burden associated with this 

information collection activity is 20,332 hours for all submitted pesticide research that involves 

intentional exposure of human subjects, and 240 hours for all other pesticide research that 

involves human subjects. Therefore the total annual burden for this information collection 

activity is estimated to be 20,572 hours.

Table 1. Respondent Burden and Cost Estimates – Research Involving Intentional 

Exposure of Human Subjects

Activities

Average Burden Hours Per 

Response

Total Per 

Response

Management Technical Clerical

$152.89 $78.54 $45.43 Hours Cost ($)

Rule familiarization and training 2 4 2 8 711

Prepare and submit protocol for 

IRB review 31 83 33 147 12,758

Prepare and submit protocol for 

EPA and HSRB review 25 181 37 243 19,719

Document ethical conduct of a 

completed study for which EPA 

and the HSRB have reviewed the 

protocol 19 113 21 153 12,734

Document ethical conduct of a 

pre-rule study for which EPA 

and the HSRB have not reviewed 

the protocol 5 16 8 29 2,385

Store, file, maintain records 4 8 6 18 1,512

Total per response 86 405 107 598 49,818
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Annual Burden: 598 hours per protocol or completed study * 34 protocols or completed 

studies per year = 20,332 hours

Annual Costs: $49,818 per study * 34 protocols or completed studies per year = 

$1,693,821

Table 2. Respondent Burden and Cost Estimates – All Other Submitted Research 

with Human Subjects

Activities

Average Burden Hours Per 

Response Total Per Response

Management Technical Clerical

$152.89 $78.54 $45.43 Hours Cost ($)

Rule familiarization and 

training 1 1 0 2 231

Prepare and Submit Ethics 

Information of Completed 

Human Studies to EPA 0 8 1 9 674

Store, file, and maintain 

records 0 0 1 1 45

Total per response 1 9 2 12 951

Annual Burden: 12 hours per study * 20 studies submitted per year = 240 hours

Annual Costs: $951 per study * 20 studies submitted per year = $19,012

6(b) Estimating Respondent Costs

The estimated annual cost for all respondents is $1,712,833. Respondent labor rates are 

estimated to be $153, $79, and $45 per hour, respectively, for managerial, technical and clerical 

labor. These labor rates were derived from the Bureau of Labor Statistics’ May 2010 National 

Industry-Specific Occupational Employment and Wage Estimates for NAICS code 541710

(Research and Development in the Physical, Engineering, and Life Sciences).

2

 These labor rates 

are fully loaded and include benefits and overhead costs, using a methodology developed by

OPP’s Biological and Economic Analysis Division (see Attachment F).

6(c) Estimating Agency Burden and Cost

The total estimated Agency annual cost is $644,038 (see Table 5). EPA activities 

include: communicating with respondents, reviewing the ethical aspects of submitted study

protocols and completed study reports, making presentations to the HSRB, documenting 

decisions, and information management activities to record, file, and track the submissions. 

 

2 Bureau of Labor Statistics. “May 2010 National Industry-Specific Occupational Employment and Wage 

Estimates: 541710 – Research and Development in the Physical, Engineering, and Life Sciences.” Accessed at 

http://www.bls.gov/oes/current/naics5_541710.htm.
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Agency labor rates are $120, $72, and $43 per hour for management, technical, and 

clerical staff, respectively. These labor rates were derived from the Bureau of Labor Statistics’ 

May 2010 National Industry-Specific Occupational Employment and Wage Estimates for 

NAICS code 999100 (Federal Executive Branch).

3

 These labor rates are fully loaded and 

include benefits and overhead costs, using a methodology developed by OPP’s Biological and 

Economic Analysis Division (see Attachment G). The details of the calculations are identified in 

Tables 3 and 4. 

Table 3. Agency Burden & Cost Estimates – Review of Research Involving Intentional 

Exposure of Human Subjects 

Activities

Average Burden Hours Per 

Response

Total Per 

Response

Management Technical Clerical

$120 $72 $43 Hours Cost ($)

Rule familiarization and training 2 2 0 4 383

Primary Review of Scientific and 

Ethical Aspects of a Protocol 1 113 0 114 8,208

Primary Review of Ethical Aspects 

of a Completed Study Report 1 57 0 58 4,200

Secondary Review of Scientific and Ethical Aspects of a Protocol or Review of 

Ethical Aspects of a Completed Study 4,172*

Store, file, and maintain records 0 0 2 2 86

Total per protocol or 

completed study 4 172 2 178 17,050

1. * The value 4,172 is computed in line 7) below.

2. Cost of HSRB members working on the HSRB report (collectively spending 240 

hours per HSRB report in FY 2008, compensated at the rate of $53/hour, plus the cost 

of EPA Office of the Science Advisor technical staff working on the HSRB report 

(171 hours per report, at the technical staff rate of $72/hour). Each HSRB report 

covers an average of 6 protocols and/or completed studies per report.

3. 240 hours/HSRB Members/report * $53/hour = $12,720/report

4. 172 hours/OSA Staff/report*$72/hour = $12,312/report

5. Total Cost for HSRB Member and OSA Staff Review Time Per Report = $12,720 + 

$12,312 = $25,032

6. If 1 report = 6 protocols

7. Total Cost for HSRB Member and OSA Staff Review Time Per Protocol = $25,032/6

= $4,172/protocol

 

3 Bureau of Labor Statistics. “May 2010 National Industry-Specific Occupational Employment and Wage 

Estimates: NAICS 999100 – Federal Executive Branch.” Accessed at 

http://www.bls.gov/oes/current/naics4_999100.htm.
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Annual Burden: 178 hours per study or protocol * 34 protocols or completed studies = 

6,052 hours

Annual Costs: 17,050 * 34 protocols or completed studies = $579,684

Table 4. Agency Burden & Cost Estimates – Review of All Other Submitted Research with 

Human Subjects

Activities

Average Burden Hours Per Study Total Per Study

Management Technical Clerical

$120 $72 $43 Hours Cost ($)

Rule Familiarization And 

Training 1 1 0 2 191

Primary Review Ethical Aspects 

of a Completed Study Report 1 40 0 41 2,983

Store, File and Maintain 

Information 0 0 1 1 43

Total per study 2 41 1 44 3,218

Annual Burden: 44 hours/study * 20 studies = 880 hours

Annual Costs: $3,218/study * 20 studies = $64,354

6(d) Bottom Line Burden Hours and Cost Tables

The total estimate represents the information collection activities expected to occur 

annually over the next three years. Table 5 provides the total estimated annual burden and costs 

for respondents, as well as the total estimated annual burden and costs for the Agency:

Table 5. Total Annual Bottom Line Burden and Costs / Master Table

Collection Activity

Annual Burden 

Hours Annual Costs

Annual Respondent Burden and Costs

Research Involving Intentional 

Exposure of Human Subjects (Table 1) 20,332 $1,693,821

All Other Submitted Research 

with Human Subjects (Table 2) 240 $19,012

Respondent Total 20,572 1,712,833

Annual Agency Burden

Research Involving Intentional 

Exposure of Human Subjects (Table 3) 6,052 $579,684

All Other Submitted Research 880 $64,354
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with Human Subjects (Table 4)

Agency Total 6,932 644,038

6(e) Reasons for Change in Burden

There is no change in the labor hours in this ICR as compared to the previous ICR. There 

is, however, an increase in the estimated burden cost as currently identified in the OMB 

Inventory of Approved ICR Burdens. This is not due to any program changes. The change in 

burden cost is due to the use of the most updated labor rates. The estimates for this renewal ICR 

are based on the labor hours of operating the HSRB that was approved by OMB during Fiscal 

Year 2008. 

6(f) Burden Statement

The total estimated annual paperwork burden to comply with this information collection 

activity is 20,572 hours. The average burden is estimated to be 598 hours per response for 

research involving intentional exposure of human subjects, and 12 hours per response for all 

other submitted research with human subjects. 

According to the Paperwork Reduction Act, “burden” means the total time, effort, or 

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

information to or for a Federal agency. The 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 number for this information collection appears at the 

beginning and end of this document. In addition OMB control numbers for EPA’s regulations, 

after initial display in the final rule, are listed in 40 CFR Part 9 (see Attachment H). 

The Agency has established a public docket for this ICR under Docket ID No. EPA-HQOPP-2011-0704, 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) 

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-2011-0704 and OMB 

Control No. 2070-0169, 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.
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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-2011-0704. 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: Final Rule; Protections for Test Subjects in Human Research

Attachment B: FIFRA Sections 3(c)(5), 3(g), 4(g)(2), and 25 

Attachment C: FFDCA Sections 408(b)(2)(A)(ii) and 408(e)(1)(C) 

Attachment D: (Reserved) Record of EPA Consultations With Respondents

Attachment E: Memorandum on Calculation of Burden and Cost

Attachment F: Wage Rate Tables for Pesticide Registrants

Attachment G: Work Sheet used to Calculate EPA Labor Costs

Attachment H: Display Related to OMB Control #2070-0169 -Listings of Related Regulations 

in 40 CFR 9.