Draft Document for Public Review - EPA is releasing this draft document solely 

for the purpose of public review and comment. This draft document is not now, 

and has not yet been, formally disseminated by EPA. It does not represent and 

should not be construed to represent any Agency policy or determination. 

Please submit comments to Docket ID # EPA-HQ-OPP-2007- 0923 at 

www.regulations.gov.

Attachment H

Office of Pesticide Programs

October 2007

General Methodology Used to Estimate 

Paperwork Burden Hours and Costs by the 

Office of Pesticide Programs for Submission of 

Required Data/Information for Responding to a 

Data Call-In Notice
Page 2 of 30

SECTION I............................................................................................................3

BACKGROUND ....................................................................................................3

I. What is the purpose of this document?...........................................................3

II. Why does EPA issue DCIs? ...........................................................................3

III. How do PRA requirements relate to DCIs?.....................................................4

IV. How does a DCI recipient respond to a DCI?.................................................5

V. DCI burden activities tables............................................................................6

 Table 1............................................................................................................6

 Table 2............................................................................................................7

VI. Variations of the response to a DCI................................................................8

a. Data generation in response to a DCI.....................................................8

b. Non-data generation in responses a DCI................................................9

SECTION II.........................................................................................................10

ESTIMATING PAPERWORK ACTVITIES OF DATA GENERATION ..................10

I. What are the key assumptions when estimating PRA burden hours and costs 

for data generation?............................................................................................10

a. Paperwork burden is generally 35% of the cost of the study.................10

b. All registrants generate all DCI data ....................................................12

II. How are test cost estimates developed? .......................................................12

III. What if test cost estimates are unavailable?.................................................12

IV. What if the available test cost estimates vary?.............................................13

V. What are the steps in calculating the paperwork burden (hours and costs)? 13

a. Calculate test costs...............................................................................13

b. Distribute paperwork activities among labor categories. .......................13

c. Calculate paperwork burden hours from labor cost distribution.............14

VI. Is the burden for those not generating data covered?. ................................15

Attachment A: Case Studies: Agency analysis of response costs of non-data

generation ..........................................................................................................17

1. Study #1 Review of the Application for New and Amended Pesticide

Registration, OMB No. 2070-0060, (EPA ICR No. 0277.14) for non-data 

generated burden hours and costs. ...........................................................17

2. Study #2 Data Generation for Pesticide Reregistration ICR, OMB No. 

2070-0107, (EPA ICR No. 1504.05)...........................................................19

3. Study #3 Economic Analysis for Proposed Changes in Data 

Requirements Rule for Biochemical and Microbial Pesticides – Cost 

Estimates for Data Waivers........................................................................21

Attachment B: FIFRA estimated test cost chart and PRA cost estimates ..........22

Contents
Page 3 of 30

I. What is the purpose of this document?

The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires federal 

agencies to estimate the “paperwork burden” for “information collection” 

activities. Under the PRA, “paperwork 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. Under the PRA, an 

“information collection” means any request for information made by a federal 

agency of ten or more respondents, and may include a request to report, retain 

records, or disclose information to third parties.

This document describes the methodology used by the Environmental Protection 

Agency’s (EPA) Office of Pesticide Programs (OPP) to estimate the paperwork 

burden hours and costs for stakeholders responding to Data Call-In (DCI) 

Notices issued by OPP under section 3(c)(2)(B) of the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA). The methodology is intended to 

provide a description of the process used by EPA to derive the estimated 

paperwork burden hours and costs associated with submitting a response to EPA

under a DCI. The methodology presented in this document should also enable

stakeholders to reproduce the burden estimates made by the Agency for DCI 

related collection activities. This increased transparency will enable the public to 

provide more substantive and meaningful feedback during public comment 

periods. This feedback will better enable the Agency to periodically amend the 

burden estimates. In addition, since the methodology presented here will be 

used by the Agency to estimate the paperwork burden for DCI requests, this 

document will serve as a reference for such calculations in the future.

II. Why does EPA issue DCIs?

With few exceptions, FIFRA requires EPA to evaluate all pesticides marketed 

and used in the United States to ensure that they will not pose unreasonable 

risks to human health and the environment. Pesticides that meet the 

requirements are granted a license or “registration” that permits their distribution, 

sale, and use according to specific use directions and requirements identified on 

the label. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA 

establishes tolerances (defined as maximum allowed pesticide residue levels) to 

specify the amount of the pesticide residue that can legally remain in or on food 

or animal feed, using a safety standard of a “reasonable certainty of no harm.” 

EPA’s review and evaluation of a new, amended, or existing pesticide 

registration or tolerance require data of sufficient quality and quantity to 

characterize the pesticide’s hazards and the potential risk from its intended uses. 

The data requested by the Agency, including the data requested in the DCI, allow 

Section I. Background
Page 4 of 30

EPA to evaluate whether a pesticide meets the statutory standard for registration, 

and allow the Agency to establish the appropriate tolerance(s) for the pesticide

under section 408 of the FFDCA.

Under section 3(c)(2)(B) of FIFRA EPA can require pesticide registrants to 

generate and submit data to the Agency, when such data are required to 

maintain an existing registration of a pesticide. EPA’s determination that 

additional data are needed could occur for various reasons, with the following 

four reasons being the most common: 

 The Reregistration Program: Section 4 of FIFRA requires EPA to reassess the health and safety data for all pesticide active ingredients 

registered before November 1, 1984, to determine whether these “older” 

pesticides meet the criteria for registration that would be expected of a 

pesticide being registered today for the first time. Section 4 directs EPA to 

use section 3(c)(2)(B) authority to obtain the required data.

 The Registration Review Program: Section 3(g) of FIFRA contains 

provisions to ensure that each pesticide will be reviewed every 15 years to 

ensure that the pesticide continues to pose no risk of unreasonable 

adverse effects on human health or the environment. Section 3(g) 

instructs EPA to use the section 3(c)(2)(B) authority to obtain the required 

data. 

 The Special Review Program: Though rare, EPA may conduct a Special 

Review if EPA believes that a registered pesticide poses risks of 

unreasonable adverse effects on human health or the environment. 

Section 3(c)(2)(B) of FIFRA provides a means of obtaining any needed 

data.

 Anticipated Residue/Percent Crop Treated Information: Under 

FFDCA, EPA can consider information on the anticipated levels of 

pesticide residues in food (the actual levels of pesticide residues that have 

been measured in food) and data on the actual percent of food treated 

with the pesticide chemical. The Agency must also provide for periodic reevaluation of this information. Under FFDCA section 408(b)(2)(E), EPA 

can issue a DCI for information relating to anticipated residues, and under

section 408(b)(2)(F) EPA can issue a DCI for percent crop treated 

estimates. 

III. How do the PRA requirements relate to DCIs?

The PRA states, “An agency may not conduct or sponsor, and a person is not 

required to respond to a “collection of information,” as defined at 5 CFR 

1320.3(c), unless the “collection” displays a currently valid control number issued 

by the Office of Management and Budget (OMB).

1

 EPA’s issuance of a DCI 

 

1 OMB is part of the Executive Office of the President.
Page 5 of 30

under FIFRA section 3(c)(2)(B) is subject to the PRA requirements because the 

DCI is considered a “collection of information” under the PRA. To comply with 

the PRA requirements, EPA must submit an Information Collection Request 

(ICR) that provides specific information to OMB about the data that EPA intends 

to call in for a given pesticide, including: a list of required studies, the practical 

utility of the data, the estimated testing costs, and the estimated paperwork 

burden. 

Under the PRA, “practical utility” means the actual, not merely the theoretical or 

potential, usefulness of information to or for an agency, taking into account its 

accuracy, validity, adequacy, and reliability, and the agency's ability to process 

the information it collects in a useful and timely fashion.2 “Burden” means the 

time, effort, or financial resources expended by persons to generate, maintain, or 

provide information to or for a Federal Agency.3” including resources to:

 review instructions; 

 develop, acquire, install, and use technology and systems;

 search data sources; 

 collect, review, validate, and verify information/data; 

 process and maintain information/data;

 disclose and transmit/submit information/data; 

 change/adjust the existing ways of complying with any previously 

applicable instructions and requirements to comply with new 

requirements; and/or

 train personnel.

IV. How does a DCI recipient respond to a DCI?

Response to a DCI can generally be divided into three phases. 

 Phase 1: Initial response: After receiving a DCI, the recipient has 90 

days to provide the initial response, which states how the recipient plans 

to comply with the DCI. A registrant may avoid generating the data if he 

qualifies for a generic data exemption (i.e., he uses a registered pesticide 

as the source of the active ingredient in his own product), cancels the 

product’s registration, submits or cites existing data, or requests a waiver.

 Phase 2: Data generation: Unless the DCI recipient can cite existing 

studies or is granted a waiver by the Agency, the DCI recipient must then 

generate the required data.

 Phase 3: Data submission: DCI recipient submits the 

studies/information to EPA.

V. DCI burden activities tables

 

2

5 CFR 1320.3(l)

3

5 CFR 1320.3(b)
Page 6 of 30

Table 1 illustrates the paperwork activities that would typically be performed by a 

DCI recipient during each of the three phases. Note that the activities that are 

likely to occur have been divided into three categories of duties: managerial, 

technical and clerical. For this table, it was assumed that the data generation 

was performed at the request of the DCI recipient by a contract laboratory. 

Although DCI recipients can certainly choose to generate the data themselves, 

the Agency believes that the assumption used provides a sufficiently 

conservative estimate, and does not expect the burden estimate for DCI 

recipients to be more than the estimate. Table 1 includes only those duties 

performed directly by the DCI recipient. 

Table 1 – Response Phases

Managerial Duties Technical Duties Clerical Duties

PHASE 1: INITIAL RESPONSE

Read regulations Read regulations Complete other 

required paperwork

Review EPA’s DCI notice Review EPA’s DCI 

notice

Communicate with EPA Assist with review of 

internal company 

information

Plan DCI response Search for existing 

data

Assist with search for 

existing data

Sign and send initial 

response forms to EPA

Prepare initial 

response forms for 

submission

Oversight of employee 

activities

PHASE 2(a): DATA GENERATION USING CONTRACT LABORATORY

Planning/oversight of 

employee and contract 

activities

Plan the data collection 

activities with the 

laboratory

Complete/file/archive 

other required 

paperwork

Make decisions Electronic data entry

Secure contract lab services 

and approve statement of 

work (SOW)

Create test protocols 

for SOW

Communicate with EPA Ensures contract 

laboratory maintains 

records and 

procedures during 

testing period in 

accordance with the 

Good Laboratory 

Practices (GLPs) 
Page 7 of 30

Oversight of employee and 

contract activities

Routine contact with 

testing laboratory 

which can include onsite visits

Analyze interim report 

and/or monthly report

Proof draft final report

Generate acceptance 

report

PHASE 3: DATA SUBMISSION TO EPA

Sign-off on submission to 

EPA

Draft summary of the 

data for cover letter

Prepare submission to 

EPA

Close-out contract

Oversight of employee 

activities

Complete other 

required paperwork

Complete/file/archive 

other required 

paperwork

Table 2 represents the PRA activities conducted at a contract laboratory. Data 

are generated by following standard operating procedures, which involve mostly 

technical duties. As part of their duties under Good Laboratory Practices (GLP), 

the scientists and technicians maintain logbooks and other records from which 

the final report is written. This table lists activities that occur in the conduct of 

studies where the test subjects are animals. Activities associated with animal 

care would not occur in studies where the test subject is inanimate, such as 

product chemistry studies, environmental fate studies or residue chemistry 

studies.

Table 2

PHASE 2(b): PRA DATA GENERATION ACTIVITIES CONDUCTED AT THE 

CONTRACT LABORATORY*

Technical Duties

Individual animal care records

Records on the rooms in which animals are housed and procedures are 

performed

Necropsy records

Equipment logbooks and computer-generated records such as chromatograms

Records on preparation of analytical standards

Freezer and storage area logbooks

Chain-of-custody forms

Quality control/quality assurance forms and review checks for accuracy

Archive and transmittal of data forms

*The Agency recognizes that in certain instances these activities might be 

conducted “in-house.” 

VI. Variations of the response to a DCI
Page 8 of 30

Because there are multiple ways of responding to a DCI, not all DCI recipients 

participate in all three phases. A registrant would participate only in phase 1 if 

they:

 Voluntarily cancel the pesticide registration

 Delete the uses of the product to which the requirements apply

 Qualify for a generic data exemption 

 Request and receive a data waiver

 Purchase/cite existing data

A registrant who purchases/cites existing data performs Phase 1 Initial response 

and Phase 3 Data Submission activities only. The initial response phase and the 

data submission phase are considered to have more-or-less fixed hours and 

costs since reading the regulations and preparing submissions to the Agency are 

independent of the type of information submitted. 

Until the Agency receives the 90-day response letters to the DCI notice from the 

registrants indicating what studies, if any, they will conduct, it is not possible to 

accurately predict the total cost and burden of developing the data. 

This methodology was prepared so that an average burden could be presented 

for a DCI recipient, regardless of the response they choose. Clearly, by 

assuming that all DCI recipients engage in all three activities the Agency has 

chosen to overestimate the burden for a DCI recipient who may not engage in 

any activities beyond Phase 1. The cost for DCI recipients who engage in a 

taskforce for data generation, voluntarily cancel the product or affected uses, 

submit or cite existing data, or are granted a waiver incur fewer burden hours and 

costs.

a. Data generation in response to a DCI

A registrant who chooses to generate data in response to the DCI may either:

 generate and submit the required data on their own, or 

 generate and submit the required data as part of a taskforce.

Data generation is considered the most expensive of the three phases. 

However, the amount of the expense is highly dependent on the type of data 

required. Therefore, it is logical to assume that the more expensive the study, 

the greater the paperwork burden hours and costs. For a DCI recipient to 

generate and submit the required data on their own is the most expensive of the 

response scenarios. However, the cost for DCI respondents who pool their 

resources for data generation with other stakeholders is less than those who 

engage in data generation activities on their own. Therefore, the Agency 

encourages cost-sharing agreements among manufacturers of specific pesticide 

chemicals to minimize the duplication of laboratory tests conducted in response 
Page 9 of 30

to a DCI. DCI notices explain the statutory provisions for cost sharing 

agreements for FIFRA.

b. Phase 1 and Phase 3 response activities for data generaters

Phase I and Phase 3 DCI response activities are a subset of the paperwork 

burden hours and costs estimates related to generating data to respond to a DCI 

notice. Unlike the wide variation of the costs for data generation, Phase 1 and 

Phase 3 response costs are more or less fixed costs. Generally, less than 

twenty-five (25) burden hours are spent on these activities at a cost of around 

$2,000 (indexed to 2006 dollars). Section II of this document presents a 

discussion of these burden hours and costs. 
Page 10 of 30

I. What are the key assumptions when estimating PRA burden hours and 

costs for data generation?

a. Paperwork activities are generally 35% of the cost of the 

study. 

For more than a decade, EPA has been estimating all the paperwork burden 

hours and costs of responding to a DCI notice as approximately 35% of the cost 

of the study, see Figure - 1 Relationship of Test Costs to Response Phases. 

This formula allows the Agency to derive a reasonable estimate of for PRA 

activities (Phases 1, 2, and 3) by using the average estimated cost of specific 

tests. This approach was adopted because it allows the Agency to consider the 

potential for there to be more burdens related to a more complex study. The 

premise is that a more expensive test may cause the respondent to incur more 

burden hours and costs than a less expensive test would. This estimate is only 

applicable to DCI-related data generation. This percentage was developed from 

numerous sources of information including agency expertise, industry 

consultation, and repeated review by the public, industry, key stakeholders, and 

OMB on the Agency’s information collection activities.

EPA assumes that 35% of the cost of any given test reflects all burdens and 

costs necessary for the completion of the paperwork activities. The paperwork 

burden and cost fall into two general categories of activity burden, administrative 

and technical:

Administrative Paperwork Burden is defined as the labor time spent 

communicating and working with the Agency and planning a response to the DCI 

and the planning of data collection and submittal activities. Generally, the 

respondent will conduct collection activities listed in the Section 1, Table 1-

Response Phases (Phase 1 and Phase 3). The labor cost related to the 

Administrative category of paperwork burden is assumed to equal 2% of the total 

test cost (2% of total test cost = Administrative Paperwork Burden Cost).

Technical Paperwork Burden is the labor time needed to complete the paperwork 

associated with the initiation of testing, collecting and maintaining data, use of 

laboratory standards, data analysis, data compiling, data entry, oversight of 

contractor or employee activities, and decision-making. Generally, the 

respondent will conduct collection activities listed in Table 1-Response Phases

(Phase 2(a)). This contract laboratory will conduct collection activities listed in 

Table 2 (Phase 2(b)). The labor cost for the technical category of paperwork 

burden is assumed to equal 33% of the total test cost. (33% of total test cost = 

Technical Paperwork Burden Cost)

Thus, [Administrative paperwork (2% of total test cost)] + [Technical paperwork 

Section II. Estimating Paperwork Activities Of Data Generation
Page 11 of 30

(33% of total test cost)] = total test-related paperwork burden hours and costs 

(35% of total test cost). This aggregate paperwork burden and cost estimate of 

35% for data generation activities is used in a number of DCI-related Agency 

information collection activities, including:

 Data Acquisition for Registration (OMB #2070-0122; EPA #1503); 

 Data Generation for Pesticide Reregistration (OMB #2070 - 0107; EPA 

#1504); 

 Data Call-Ins for Special Review and Registration Review Programs (OMB 

#2070-0057; EPA #0922); and 

 Anticipated Residue/Percent Crop Treated (OMB #2070-0164; EPA 

#1911).

Phase III:

Data Submission 

to EPA

Phase II (a&b)

Data Generation 

including technical 

duties conducted at 

Laboratories

Phase 1:

Initial Response to 

DCI

35% of test cost 

covers the PRA 

burden hours and 

costs of all three 

phases of a DCI 

response 
Page 12 of 30

Figure - 1 Relationship of Test Costs to Response Phases 

b. All registrants generate all DCI data

The paperwork activity estimates are based on the average cost of generating 

new data. The total cost of the paperwork burden hours and costs is equal to 

approximately 35% of the total costs to generate new data. This approach 

assumes: 

 Registrants generate all of the data as specified in the DCI notice.4

 All data generation was performed by an independent laboratory. 

 Paperwork burden consists of an administrative (2%) and technical (33%) 

burden. These two categories relate to office and laboratory activities, 

respectively.

 Paperwork burden is disaggregated by labor category as follows:5

a. Managerial (20%)

b. Technical (65%)

c. Clerical (15%) 

 Labor rates are derived from the parent ICR

 Labor rates are “fully loaded6”

To estimate paperwork activities for each type of labor category (managerial, 

technical, and clerical), the disaggregated paperwork burden costs are divided by 

their corresponding labor rates ($/hr). EPA assumes that DCI respondents who 

generate all requested data on their own is the most expensive of the response 

options considered and represents the maximum potential estimate of overall 

burden.

II. How are test cost estimates developed?

The Agency maintains an archive of the basic FIFRA study cost estimates that 

were developed through surveys of independent testing laboratories, Agency 

economic analyses, and registrant comments during ICR renewal periods. To

the extent possible, EPA uses multiple sources to provide test cost estimates, 

which are updated as needed. Attachment B contains a listing of the FIFRA study 

cost estimates currently on file with the Agency. The chart also provides the 

paperwork burden hour and cost estimates for specific studies. 

III. What if test cost estimates are unavailable? 

 

4

Assumes registrants perform most of the PRA activities highlighted in, Section I-V, “DCI burden 

activity tables;” Table 1 – Response Phases 

5

See Section I-V, “DCI burden activity tables;” Table 1 – Response Phases; which lists specific 

managerial, technical, and clerical duties.

6

“Fully loaded” labor rates are meant to be the estimated costs of wages, overhead, and benefits 

paid to an employee.
Page 13 of 30

The Agency may request certain special studies or non-guideline studies that 

have not been previously required, and for which test cost estimates have not yet 

been calculated. If the estimated test cost is not readily available to the Agency 

at the time that a particular test is requested, EPA will estimate the cost on the 

basis of:

 EPA staff expertise and experience;

 similarity with another study protocol for which cost estimates are 

available; 

 type of study requested (e.g., animal studies, field monitoring, and other 

possible test parameters);

 level of work that EPA expects will be involved in generating the data (high 

medium, or low effort required); and/or 

 time required to complete the test.

The Agency’s estimate would then serve as the default test cost for use in 

calculating the paperwork burden. EPA will update and revise these default test 

costs as more reliable estimates are obtained.

IV. What if the available test cost estimates vary? 

To the extent possible, EPA uses multiple sources to provide test cost estimates. 

If several cost estimate exist for a particular study, but the differing estimates fall 

within an acceptable range, EPA will use the average estimate as its estimate. 

For example, if test cost estimates for a study were quoted at $20,000, $30,000, 

and $40,000, these estimates would be considered to fall within an acceptable 

range, and the average of $30,000 would be used in EPA’s estimation of 

paperwork burden. If EPA finds that the quoted test costs for a given test varies 

widely among sources (i.e., the variation is not within a reasonable range), then 

EPA will make a case-by-case decision on how to estimate an average test cost

using the criteria listed in section II-III (What if tests costs are unavailable).

V. What are the steps in calculating the paperwork burden (hours and 

costs)?

a. Calculate test costs

Using the EPA archive information of FIFRA study cost estimates, the Agency 

calculates the total paperwork burden hours and costs for a test as 35% of the 

total test cost (administrative paperwork burden as 2% and technical paperwork 

burden as 33% of the total test cost). This percent-based estimate of paperwork 

burden is reflective of expert opinion, information from industry, various 

proprietary information/data, and a general assessment of test costs.

b. Distribute paperwork activities among labor categories. 
Page 14 of 30

As an entity prepares a data generating response to the DCI notice, EPA 

assumes managerial, technical, and clerical staff will undertake certain activities. 

Paperwork burden costs are divided among managerial, technical, and clerical 

staff labor categories (see Table 3, below) to reasonably reflect, on average, the 

percent of work performed.

Table 3: Distribution of Paperwork Activities Across Labor Categories*

Labor category % of Paperwork Activities Performed

Managerial 20%

Technical 65%

Clerical 15%

 

Using this percentage system, EPA can assign a paperwork activity cost to each 

labor category.

For example, study guideline 850.1735, Whole Sediment Acute Toxicity, 

has an estimated cost of $20,250. To assign a paperwork activity cost to 

each labor category, and to eventually arrive at a total estimate of 

paperwork burden in hours and costs, the steps below are taken. 

Labor category activities:

Managerial labor: $1,417.50 = ($7,087.50 * 0.20)

Technical labor: $4,606.88 = ($7,087.50 * 0.65)

Clerical labor: $1,063.12 = ($7,087.50 * 0.15)

Total paperwork activities cost: = $7,087.50

EPA would estimate that $7,087.50 or 35% of the total test cost represents the 

cost of the total paperwork burden activities.

c. Calculate paperwork burden hours from labor cost 

distribution. 

The second component for estimating DCI PRA activities is to estimate the 

average amount of time required to complete activities such as obtaining, 

compiling, preparing and submitting information to EPA. After distributing the 

paperwork costs among the managerial, technical and clerical labor categories, 

the paperwork burden hours are then derived by dividing the costs using fullyloaded wage rates ($/hour) compiled from the Department of Labor’s Bureau of 

Labor Statistics which are shown in Table 4. 

Table 4: Fully-Loaded Hourly Wage Rates, by Labor Category*

Labor category Rate ($/hour)

Managerial $100.86

Technical $64.80

Clerical $33.05
Page 15 of 30

To estimate paperwork burden in hours, using the hourly wage rates listed in 

Table 4, the steps below are taken. 

Distribution of paperwork burden hours and costs for labor categories:

Managerial labor: 14.05 hours ($1,417.50)

Technical labor: 71.04 hours ($4,606.88)

Clerical labor: 32.17 hours ($1,063.12)

Total paperwork burden hours = 117.31 hours

VI. Is the burden for those not generating data covered? 

As discussed in Section 1-VI, (Variations of the response to a DCI), there are 

multiple ways of responding to a DCI and not all DCI recipients will generate and 

submit data as part of the DCI response. Until the Agency receives the 90-day 

response letters to the DCI notice from the registrants indicating what studies, if 

any, they will conduct, it is not possible to predict the burden and costs of 

developing the data. Since the Agency cannot predict the number of DCI 

recipients who will actually generate data or the amount of data that might be 

submitted, EPA submits paperwork burden estimates to OMB for DCI response 

activities under all three Phases (1, 2, and 3). Therefore the Agency uses a 

default assumption that all DCI recipients will need to generate all of the data 

requested. The Agency recognizes that using this default assumption inflates the 

paperwork burden estimates associated with the DCI and renders an 

overstatement of the burden and cost. The Phase I and Phase 3 response 

activity burden hours and costs are accounted for in the existing DCI ICRs as a 

subset of the paperwork burden estimates for information collection activities that 

are related to generating data to respond to a DCI notice.7

In 2006, the Agency conducted a preliminary analysis of existing information from 

certain collections to estimate the PRA burden of paperwork activities that do not 

involve data generation, such as Phase 1 responses to DCIs . For the study, the 

Agency chose two ICRs in which PRA burden hours and costs for paperwork 

activities that do not involve data generation are clearly defined. The first, the 

Application for New and Amended Pesticide Registration ICR, OMB No. 2070-

0060, (EPA ICR No. 0277.14) represents the majority of paperwork activities that 

do not involve data generation for applications for pesticide registration and the 

second ICR, the Data Generation for Pesticide Reregistration ICR, OMB No. 

2070-0107, (EPA ICR No. 1504.05) represents all DCI related PRA burden and 

costs. The subset of paperwork activities that do not involve data generation was 

tallied and the burden hours and costs from both ICRs were estimated. Finally, 

information from the Economic Analysis of the Proposed Change to Data 

Requirements Rule for Biochemical and Microbial Pesticides, September 2, 

 

7

See Section 1-V “DCI burden activity tables;” Table 1 – Response Phases.
Page 16 of 30

2005,8 was also used to extract costs for activities that do not involve data 

generation. Of these three studies, the estimates of costs of paperwork that do 

not involve data generation were 1) $1169.00; 2) $1417.00 and 3) $2000.00 per 

response respectively. The Agency believes these costs generally represent the 

range for paperwork burden and cost that registrants who are not generating 

data might be incur when creating Phase 1 responses. These analyses are 

discussed in detail in Attachment A.

 

8

See Environmental Protection Agency proposed rule 40 CFR parts 158 and 172, Subparts L&M: 

Data Requirements for Registration of Biochemical and Microbial Pesticides, (45 FR 12072 

Wednesday March 8, 2006), section XVII Regulatory Assessment. For specific information refer 

to the docket EPA-HQ-OPP-2004-0415, document 6, U.S. EPA, 2005, “Economic Analysis of the 

Proposed Change to Data Requirements Rule for Biochemical and Microbial Pesticides,” 

FEAD/OPP/U.S. EPA, Washington, DC. 
Page 17 of 30

Attachment A

Case Studies: Agency Analysis of Response Costs for

Phase 1 Responses

In this study, EPA assumes: 

1. Paperwork activities for applications for registration for “me-too” 

pesticides9are similar to paperwork activities for developing a DCI 

response that does not entail generating new data or requesting a waiver. 

2. Estimated burden and costs listed in Table A are fixed, consistent costs 

for every respondent, and are not derived from any test cost estimates.

3. Technical labor efforts are not calculated because the Agency assumes 

no technical burden would be involved in developing a DCI response that 

does not entail generating new data or requesting a waiver.10

4. The paperwork burden for phase 1 responses that are similar to activities 

in developing registration applications may be described as follows:

a. read and discuss test requirements (read the DCI letter to 

understand what data are to be submitted); 

b. plan activities (includes time for reviewing internal company 

information); 

c. complete paperwork (prepare necessary correspondence, 

documents to EPA);

d. Store/maintain information (maintain information submitted to the 

 

9

“Me too” pesticides are pesticides that are substantially similar to an existing pesticide. When 

applying for a “me-too” registration, a registrant would either cite existing data or claim eligibility 

for a formulator’s exemption. A registrant is eligible for a formulators exemption if he uses a 

registered pesticide product as the source of the active ingredient in his product. Little or no 

technical labor is involved for this type of response. 

10 As an example, consider the DCI respondent who claims a generic data exemption (GDE) as 

their response to a DCI. A generic data exemption is the same as a formulator’s exemption. Little 

or no technical labor burden is involved for this type of response.

1. Study #1: Review of the Application for New and Amended 

Pesticide Registration, OMB No. 2070-0060, (EPA ICR No. 

0277.14) representing burden hours and costs for paperwork 

activities that do not involve data generation for applications 

for pesticide registration 
Page 18 of 30

Agency in company files).

5. Paperwork burden for such activities may be disaggregated by labor 

category as follows (percentages are approximations):

a. Managerial (65%)

b. Technical (0%)

c. Clerical (35%)

6. Labor rates are derived from the parent ICR.

7. Labor rates are fully loaded.

The supporting statement of the Application for New and Amended Pesticide 

Registration ICR characterizes the activities that would be needed for an 

application/notification. These activities are substantially similar to those of 

Phase 1: Initial Response that do not involve generating data or requesting a 

data waiver. The applicable activities are reproduced in Table A below:

Table A: Estimated Burden/Cost for Phase 1 Response*

Collection Activity Burden Hours Totals

Management Technical Clerical Hours Cost

Read instructions 7 0 0 7 938

Plan activities 0.5 0 0 0.5 67

Complete Paperwork 0 0 3 3 123

Store/maintain data 0 0 1 1 41

Totals 7.5 0 4 11.5 1169

(* Indexed to 2005 dollars)

After distributing the paperwork costs among the managerial and clerical staff 

labor categories, the paperwork burden hours are then derived by dividing the 

costs using the fully-loaded wage rates ($/hour) compiled in the parent ICR, 

Review of the Application for New and Amended Pesticide Registration, OMB 

No. 2070-0060, (EPA ICR No. 0277.14) approved by Office of Management and 

Budget, November 8, 2005. 
Page 19 of 30

In this study EPA assumes:

1) The total paperwork burden hours and costs for Phase 1 responses are 

approximately 7 percent of the estimated average cost to generate new 

data. 

2) Registrant responses to the DCI notice that do not involve data generation 

include voluntary cancellation, submitting or citing existing data, 

requesting a data waiver, or claiming eligibilitygeneric data exemption.

3) Paperwork activities that do not involve data generation may be described 

as follows:

a. read and discuss test requirements (read the DCI letter to 

understand what data are to be submitted); 

b. plan activities (developing options for not generating new data

includes reviewing internal company information for existing data); 

c. complete paperwork (prepare necessary correspondence, 

documents and/or waiver requests to avoid having to submitting 

data to EPA);

d. record, maintain and file information (maintain information 

submitted to the Agency in company files).

4) Paperwork burden for Phase 1 DCI responses activities may be 

disaggregated by labor category as follows (percentages are 

approximations):

e. Managerial (50%)

f. Technical (5%)

g. Clerical (45%)

5) Labor rates are derived from the parent ICR 

6) Labor rates are fully loaded.

a. Calculate Cost of Paperwork. Using the EPA maintained database of test cost 

estimates, the Agency calculates the total paperwork burden cost for a test as 

7% of the total test cost because based on the percentage breakdown for 

paperwork burden applicable to non-data generation activities for this ICR. This 

percent-based estimate of paperwork burden is reflective of expert opinion, 

information from industry, various proprietary information/data, and a general 

assessment of test costs. These activities represent the Phase I DCI response 

activities discussed in section IV. 

b. Distribute Paperwork Costs Among Labor Categories. As an entity prepares a 

response of non-data generation in response to the DCI notice, EPA assumes

certain activities will be conducted by managerial, technical, and clerical staff. 

Paperwork activities are divided among these labor categories (see Table B 

below) to reasonably reflect, on average, the percent of work performed. These 

2. Study #2: Data Generation for Pesticide Reregistration ICR, 

OMB No. 2070-0107, (EPA ICR No. 1504.05). 
Page 20 of 30

percentage breakdowns by labor category, derived from the parent ICR Data 

Generation for Pesticide Reregistration ICR, OMB No. 2070-0107, (EPA ICR No. 

1504.05), are consistent for burden activities associated with confirmatory DCIs, 

product specific DCIs, and submission of voluntary studies cited within the parent 

ICR.

Table B: Distribution of Burden Across Labor Categories

Labor category % of Paperwork Burden Activities Performed

Managerial 50%

Technical 5%

Clerical 45%

For example the study guideline 850.1735, Whole Sediment Acute 

Toxicity, has an estimated cost of $20,250. Estimates for paperwork cost 

for these non-data generation activities would be: 

Managerial labor: $708.75 = ($1,417.50 * 0.50)

Technical labor: $70.88 = ($1,417.50 * 0.05)

Clerical labor: $637.87 = ($1,417.50 * 0.45)

Total labor: $1,417.50 

EPA would estimate that $1,417.50 or 7% of the total test cost represents the 

cost of the total paperwork burden activities.

c. Calculate Paperwork Burden Hours From Labor Cost Distribution. After 

distributing the paperwork costs among the managerial, technical and clerical 

staff labor categories, the paperwork burden hours are then derived by dividing 

the costs using fully-loaded wage rates ($/hour) cited in the parent ICR and listed 

in Table C. 

Table C: Fully-Loaded Hourly Wage Rates, by Labor Category*

Labor category Rate ($/hour)

Managerial $130

Technical $88

Clerical $40

 (Labor costs cited in the parent ICR - Indexed to 2004 dollars) 

To estimate paperwork burden in hours, using the hourly wage rates listed 

in Table C, the steps below are taken. 

Managerial labor: 5.45 hours ($708.75 ÷ $130/hr)

Technical labor: 0.81 hours ($70.88 ÷ $88/hr)

Clerical labor: 15.95 hours ($637.87 ÷ $40/hr)

Total hours: 22.21 hours
Page 21 of 30

Under 40 CFR 158.45, the Agency may waive data requirements on a case-bycase basis in response to specific requests by applicants. The Agency believes 

the paperwork burden and cost for developing a data waiver request is a 

relatively fixed cost. When the Agency analyzed burden and cost for data waivers 

in the Economic Analysis for Proposed Changes in Data Requirements Rule for 

Biochemical and Microbial Pesticides in 2005, the cost of applying for waivers 

was estimated to be approximately $2,000 per firm per registration action,

regardless of the number of tests a waiver is applied for, if at least one waiver 

was granted. 11 EPA believes this unit of cost/burden may be applicable to the 

data waivers submitted to the Agency in response to a DCI. Under this 

assumption, all non-data generation paperwork activities would be placed at a 

fixed burden of 20 hours and the burden hours would be distributed as 

represented in Table D below.

Table D: Industry Estimated Burden/Cost Submitting a Data Waivers 

Response*

Collection Activity Burden Hours Totals

Management Technical Clerical Hours Cost

Research, Literature 

searches, 

Calculations & analysis

10

10

1000

Compiling rational 8 8 800

Review document file and 

submit 1 1 2 200

Total 20 2000

 

11 The Biopesticide Industry Alliance Regulatory Committee provided additional informal cost 

estimates to EPA. Burden breakdown and costs estimates would be: Research, literature 

searches, calculations, analysis etc. = 10 hours = $1000 writing; compiling the rationale = 8 hours 

= $800; and managerial/clerical = 2 hours = $200. For a total of $2,000.00 for each waiver. A 

general $100.00 per hour for consultant costs was provided to EPA. 

 

3. Study #3: Economic Analysis for Proposed Changes in 

Data Requirements Rule for Biochemical and Microbial 

Pesticides – Cost Estimates for Data Waivers. 
Page 22 of 30

Attachment B

Chart: FIFRA Estimated Study Costs And Paperwork 

Burden Hour And Cost Estimates 
Test Information

Paperwork Burden Totals

(35% of study cost)

Test Guideline/

Section Test Name

AverageTest Cost

Total Paperwork Burden Cost

Total Paperwork Burden Hours

High Test Cost

(High A

V

G for 2005 SciReg)

Low

Test Cost

(Low

A

V

G for 2005 SciReg)

Product Performance 

810.1000 Overview, Definitions, and General Considerations $100,000.0 $35,000.0 443.6 $100,000.0 $100,000.0

810.1550 Product Identity and Disclosure of Ingredients (Composition) (Chemical Identity) $223.0 $78.1 1.0 $223.0 $223.0

810.2100 Products for hard surfaces -EPA Disinfectant test $6,600.0 $2,310.0 29.3 $7,200.0 $6,000.0

810.2100 Products for hard surfaces - AOAC Fungicide test $1,600.0 $560.0 7.1 $2,000.0 $1,200.0

810.2100(b)&(i) Chemical Analysis $5,339.0 $1,868.7 23.7 $6,701.0 $3,976.0

810.2100(m)(2) Products for hard surfaces - AOAC Germicidal, detergent sanitizers $3,500.0 $1,225.0 15.5 $4,000.0 $3,000.0

810.21000(j) Products for hard surfaces -Sanitizer test non food $4,000.0 $1,400.0 17.7 $5,000.0 $3,000.0

810.2100b,c,d or i Products for hard surfaces -AOAC use dilution test, germicidal $6,000.0 $2,100.0 26.6 $7,000.0 $5,000.0

810.2100c,d,e Products for hard surfaces -AOAC Use dilution/germicidal spray/carrier $6,000.0 $2,100.0 26.6 $7,000.0 $5,000.0

810.2100(f) Products for hard surfaces - Fungicidal test $1,600.0 $560.0 7.1 $2,000.0 $1,200.0

810.2100(g) Products for hard surfaces - Virucidal activity method $4,000.0 $1,400.0 17.7 $6,000.0 $2,000.0

810.2100(g) Products for hard surfaces -AOAC Tuberculocidal test $3,250.0 $1,137.5 14.4 $5,000.0 $1,500.0

810.2100(l) Products for hard surfaces - Hard inanimate surface non food $4,000.0 $1,400.0 17.7 $5,000.0 $3,000.0

810.2200 Products for hard surfaces - AVG $6,187.0 $2,165.5 27.4 $6,187.0 $6,187.0

810.2200 - itemized Limited disinfectant $4,201.0 $1,470.4 18.6 $5,010.0 $3,391.0

810.2200 - itemized Broad spectrum disinfectant $5,763.0 $2,017.1 25.6 $6,720.0 $4,806.0

810.2200 - itemized Hospital disinfectant $5,993.0 $2,097.6 26.6 $7,000.0 $4,986.0

810.2200 - itemized Fungicidal disinfectant $4,219.0 $1,476.7 18.7 $4,865.0 $3,572.0

810.2200 - itemized Virucidal disinfectant $13,068.0 $4,573.8 58.0 $19,574.0 $6,561.0

810.2200 - itemized Tuberculocidal disinfectant $4,691.0 $1,641.9 20.8 $5,633.0 $6,748.0
Page 24 of 30

810.2200 - itemized Additional bacteria $4,082.0 $1,428.7 18.1 $4,803.0 $3,361.0

810.2200 - itemized Non-food contact $5,198.0 $1,819.3 23.1 $6,026.0 $4,370.0

810.2200 - itemized Food contact - Halide products $4,455.0 $1,559.3 19.8 $5,195.0 $3,714.0

810.2200 - itemized Food contact - Non-halide products $6,086.0 $2,130.1 27.0 $7,301.0 $4,870.0

810.2200 - itemized Sanitizers for urinal and toilet bowl water and in-tank sanitizers $5,672.0 $1,985.2 25.2 $6,902.0 $4,441.0

810.2200 - itemized Residual self-sanitizing - wet surfaces $5,210.0 $1,823.5 23.1 $3,969.0 $6,451.0

810.2200 - itemized Sterilants $11,803.0 $4,131.1 52.4 $11,936.0 $11,669.0

810.2300b Products for fabrics/textiles -EPA Carpet Sanitizer $3,250.0 $1,137.5 14.4 $5,000.0 $1,500.0

810.2400 Products for air sanitizers $5,500.0 $1,925.0 24.4 $6,500.0 $4,500.0

810.2400(b)(j) Chemical Analysis $175.0 $61.3 0.8 $350.0 $0.0

810.2400(b)(l) Chemical Analysis $4,000.0 $1,400.0 17.7 $4,000.0 $4,000.0

810.2600 Products for microbial pests associated with human and animal waste $5,720.0 $2,002.0 25.4 $5,720.0 $5,720.0

810.2700(d) Products for treating water systems AOAC- water disinfectants pools $7,500.0 $2,625.0 33.3 $10,000.0 $5,000.0

810.3000 General considerations for Efficacy of invertebrate control agents $600.0 $210.0 2.7 $600.0 $600.0

810.3100 Soil treatments for imported fire ants $140,000.0 $49,000.0 621.1 $200,000.0 $80,000.0

810.3200 Livestock,poultry,fur and wool bearing animal treatments $30,000.0 $10,500.0 133.1 $50,000.0 $10,000.0

810.3300 Treatments to control pests of human and pets $50,000.0 $17,500.0 221.8 $60,000.0 $40,000.0

810.3400 Mosquito,blackfly and biting midge treatments $140,000.0 $49,000.0 621.1 $200,000.0 $80,000.0

810.3500 Premises Treatments $700,000.0 $245,000.0 3,105.3 $800,000.0 $600,000.0

810.3600 Structural Treatments $1,200.0 $420.0 5.3 $1,200.0 $1,200.0

810.3700 Insect repellants for human skin and outdoor premises $5,000.0 $1,750.0 22.2 $5,000.0 $5,000.0

810.3800 Methods for efficacy testing of termite baits $60,000.0 $21,000.0 266.2 $100,000.0 $20,000.0

Product Chemistry

830.1550 Product identity and composition $233.0 $81.6 1.0 $223.0

830.1600 Description of materials used to produce the product $334.0 $116.9 1.5 $501.0 $167.0

830.1620 Description of production process $418.0 $146.3 1.9 $167.0 $668.0

830.1650 Description of formulation process $418.0 $146.3 1.9 $167.0 $668.0

830.1670 Discussion of formulation of impurities $418.0 $146.3 1.9 $167.0 $668.0

830.1700 Preliminary analysis $31,715.0 $11,100.3 140.7 $50,054.0 $8,875.0

830.1750 Certified limits $248.0 $86.8 1.1 $330.0 $165.0

830.1800 Enforcement analytical method $15,454.0 $5,408.9 68.6 $21,538.0 $9,371.0

830.1900 Submittal of samples $495.0 $173.3 2.2 $660.0 $330.0

830.6302 Color $700.0 $245.0 3.1 $1,000.0 $400.0

830.6303 Physical state $700.0 $245.0 3.1 $1,000.0 $400.0

830.6304 Odor $700.0 $245.0 3.1 $1,000.0 $400.0

830.6313 Stability to normal and elevated temperatures, metals, and metal ions $8,250.0 $2,887.5 36.6 $12,000.0 $4,500.0

830.6314 Oxidation/reduction: chemical incompatibility $2,994.0 $1,047.9 13.3 $3,044.0 $2,944.0

830.6315 Flammability $2,000.0 $700.0 8.9 $3,000.0 $1,000.0

830.6316 Explodability $4,163.0 $1,457.1 18.5 $4,163.0 $4,163.0

830.6317 Storage stability $11,500.0 $4,025.0 51.0 $15,000.0 $8,000.0
Page 25 of 30

830.6319 Miscibility $1,100.0 $385.0 4.9 $1,500.0 $700.0

830.6320 Corrosion characteristics $2,750.0 $962.5 12.2 $3,500.0 $2,000.0

830.6321 Dielectric breakdown voltage $2,525.0 $883.8 11.2 $2,675.0 $2,375.0

830.7000 pH $750.0 $262.5 3.3 $1,000.0 $500.0

830.7050 UV/visible light absorption $2,022.0 $707.7 9.0 $2,072.0 $1,972.0

830.7100 Viscosity $1,400.0 $490.0 6.2 $2,000.0 $800.0

830.7200 Melting point/melting range $1,200.0 $420.0 5.3 $1,600.0 $800.0

830.7220 Boiling point/boiling range $1,500.0 $525.0 6.7 $2,000.0 $1,000.0

830.7300 Density/relative density/bulk density $1,400.0 $490.0 6.2 $2,000.0 $800.0

830.7370 Dissociation constants in water $4,845.0 $1,695.8 21.5 $4,845.0 $4,845.0

830.7520 Particle size, fiber length, and diameter distribution $1,333.0 $466.6 5.9 $1,333.0 $1,333.0

830.7550 Partition coefficient (n-octanol/water) - shake flask method $6,667.0 $2,333.5 29.6 $7,333.0 $6,000.0

830.7560 Partition coefficient (n-octanol/water) -generator column $6,667.0 $2,333.5 29.6 $7,333.0 $6,000.0

830.7570 Partition coefficient (n-octanol/water) -estimation chromatography $4,388.0 $1,535.8 19.5 $4,700.0 $4,075.0

830.7840 Water Solubility: column elution/shake flask $9,635.0 $3,372.3 42.7 $11,322.0 $7,947.0

830.7860 Water solubility $9,635.0 $3,372.3 42.7 $11,322.0 $7,947.0

830.7950 Vapor pressure $15,000.0 $5,250.0 66.5 $20,000.0 $10,000.0

Spray Drift

840.1100 Spray droplet size spectrum $258,750.0 $90,562.5 1,147.9 $340,000.0 $177,500.0

840.1200 Spray drift field deposition $16,250.0 $5,687.5 72.1 $25,000.0 $7,500.0

Ecological Effects Tests

850.1000 Use Profile $251.0 $87.9 1.1 $334.0 $167.0

850.1010 Aquatic invertebrate acute toxicity, freshwater daphnids $17,000.0 $5,950.0 75.4 $20,000.0 $14,000.0

850.1020 Gammarid acute toxicity test $0.0 $0.0 0.0 $0.0 $0.0

850.1025 Oyster acute toxicity test $32,725.0 $11,453.8 145.2 $32,725.0 $7,550.0

850.1035 Mysid acute toxicity test $32,725.0 $11,453.8 145.2 $32,725.0 $7,550.0

850.1045 Penaeid acute toxicity test $32,725.0 $11,453.8 145.2 $32,725.0 $7,550.0

850.1055 Bivalve acute tox larval (embryo/larval) $32,725.0 $11,453.8 145.2 $32,725.0 $7,550.0

850.1075 Fish acute toxicity (freshwater) $17,000.0 $5,950.0 75.4 $28,061.0 $10,066.0

850.1075 Fish acute toxicity test (estaurine/marine) $20,138.0 $7,048.3 89.3 $20,138.0 $20,138.0

850.1300 Daphnid chronic toxicity test $118,063.0 $41,322.1 523.7 $162,800.0 $73,325.0

850.1350 Mysid chronic tox - aquatic invertebrate life-cycle (saltwater) $36,333.0 $12,716.6 161.2 $41,000.0 $31,667.0

850.1400 Fish early-life stage toxicity test (freshwater) $37,279.0 $13,047.7 165.4 $41,379.0 $33,179.0

850.1450 Fish early-life stage toxicity test (saltwater) $75,000.0 $26,250.0 332.7 $0.0 $0.0

850.1500 Fish life-cycle toxicity $512,500.0 $179,375.0 2,273.5 $650,000.0 $375,000.0

850.1710 Aquatic Bioavailability/Biomagnification: Oyster BCF $123,919.0 $43,371.7 549.7 $143,919.0 $103,919.0

850.1730 Aquatic Bioavailability/Biomagnification: Fish BCF $140,452.0 $49,158.2 623.1 $169,279.0 $111,624.0

850.1735 Whole sediment acute toxicity invertebrates (freshwater) $20,250.0 $7,087.5 89.8 $21,500.0 $26,000.0

850.1740 Whole sediment acute toxicity invertebrates (marine) $37,500.0 $13,125.0 166.4 $50,000.0 $25,000.0

850.1790 Chironomid sediment toxicity test $83,000.0 $29,050.0 368.2 $83,000.0 $83,000.0

850.1800 Tadpole/sediment subchronic toxicity test $195,856.0 $68,549.6 868.9 $195,856.0 $195,856.0

850.1850 Aquatic food chain transfer - Bioavailability $325,000.0 $113,750.0 1,441.8 $500,000.0 $150,000.0

850.1900 Generic freshwater microscosm test (laboratory) $295,000.0 $103,250.0 1,308.7 $360,000.0 $230,000.0
Page 26 of 30

850.1925 Site-specific aquatic microcosm test (laboratory) $250,000.0 $87,500.0 1,109.0 $250,000.0 $250,000.0

850.1950 Simulated or actual field testing - field animal $512,500.0 $179,375.0 2,273.5 $650,000.0 $375,000.0

850.1950 Simulated or actual field testing - aquatic $600,000.0 $210,000.0 2,661.7 $700,000.0 $500,000.0

850.1950 Simulated or actual field testing - insect predators $87,500.0 $30,625.0 388.2 $100,000.0 $75,000.0

850.1950 Simulated or actual field testing - plants $62,500.0 $21,875.0 277.3 $75,000.0 $50,000.0

850.2100 Avian acute oral toxicity test $10,100.0 $3,535.0 44.8 $13,800.0 $6,400.0

850.2200 Avian dietary toxicity test $6,480.0 $2,268.0 28.7 $6,647.0 $6,313.0

850.2300 Avian reproduction test $168,250.0 $58,887.5 746.4 $215,500.0 $121,000.0

850.2400 Wild mammal acute toxicity $35,000.0 $12,250.0 155.3 $50,000.0 $20,000.0

850.2500 Simulated or actual field testing terrestrial wildlife $527,502.0 $184,625.7 2,340.1 $552,000.0 $502,000.0

850.2500 Simulated or actual field testing - birds $600,000.0 $210,000.0 2,661.7 $700,000.0 $500,000.0

850.3020 Honey bee acute contact toxicity $3,175.0 $1,111.3 14.1 $3,175.0 $3,175.0

850.3030 Honey bee toxicity of residues on foliage $13,368.0 $4,678.8 59.3 $16,670.0 $10,065.0

850.3040 Field testing for pollinators $47,500.0 $16,625.0 210.7 $65,000.0 $30,000.0

850.4000 Background - Nontarget plant testing $0.0 $0.0 0.0 $0.0 $0.0

850.4025 Target area phytotoxicity $0.0 $0.0 0.0 $0.0 $0.0

850.4100 Terrestrial plant toxicity (seedling emergence, Tier I) $14,625.0 $5,118.8 64.9 $15,625.0 $13,625.0

850.4150 Terrestrial plant toxicity (vegetative vigor, Tier I) $14,625.0 $5,118.8 64.9 $15,625.0 $13,625.0

850.4200 Seed germination/root elongation toxicity test $10,292.0 $3,602.2 45.7 $15,875.0 $4,709.0

850.4200 Seed germination/root elongation toxicity test $25,602.5 $8,960.9 113.6 $30,930.0 $20,275.0

850.4230 Early seed growth toxicity test $0.0 $0.0 0.0 $0.0 $0.0

850.4225 Seedling emergence, Tier II $20,375.0 $7,131.3 90.4 $22,000.0 $18,750.0

850.4250 Vegetative vigor, Tier II $24,500.0 $8,575.0 108.7 $26,500.0 $22,500.0

850.4300 Terrestrial plants field study, Tier III $111,863.0 $39,152.1 496.2 $126,863.0 $26,500.0

850.4400 Aquatic plant toxicology test using Lemna spp., Tier I $35,155.0 $12,304.3 156.0 $39,525.0 $18,750.0

850.4400 Aquatic plant toxicology test using Lemna spp., Tier II $35,155.0 $18,632.2 236.2 $35,155.0 $35,155.0

850.4450 Aquatic plants field study, Tier III $0.0 $0.0 0.0 $0.0 $0.0

850.5400 Algal Toxicity Tier I and Tier II $35,155.0 $12,304.3 156.0 $35,155.0 $35,155.0

na Acute toxicity to aquatic insects $0.0 $0.0 0.0 $0.0 $0.0

na Aquatic insect life-cycle study $0.0 $0.0 0.0 $0.0 $0.0

na Simulated or actual field testing for aquatic insects $0.0 $0.0 0.0 $0.0 $0.0

na Nontarget insect testing - predators and parasites $0.0 $0.0 0.0 $0.0 $0.0

na Nontarget insect testing - predators and parasites $0.0 $0.0 0.0 $0.0 $0.0

Health Effects

870.1100 Acute oral toxicity (rat) $3,473.0 $1,215.6 15.4 $4,015.0 $2,932.0

870.1200 Acute dermal toxicity $2,000.0 $700.0 8.9 $3,000.0 $1,000.0

870.1300 Acute inhalation toxicity (rat) $2,000.0 $700.0 8.9 $3,000.0 $1,000.0

870.1300 Acute inhalation tox (microbials) $12,000.0 $4,200.0 53.2 $20,000.0 $4,000.0

870.2400 Acute eye irritation (rabbit) $2,000.0 $700.0 8.9 $3,000.0 $1,000.0

870.2500 Acute dermal irritation $2,000.0 $700.0 8.9 $3,000.0 $1,000.0

870.2600 Skin (dermal) sensitization $8,000.0 $2,800.0 35.5 $10,000.0 $6,000.0

870.3100 90-day oral toxicity in rodents $138,106.0 $48,337.1 612.7 $142,517.0 $133,695.0

870.3150 90-day oral toxicity in non-rodents $221,047.0 $77,366.5 980.6 $221,047.0 $221,047.0

870.3200 21/28-day dermal toxicity $83,240.0 $29,134.0 369.3 $84,681.0 $81,798.0
Page 27 of 30

870.3250 90-day dermal toxicity $137,094.0 $47,982.9 608.2 $138,114.0 $137,094.0

870.3465 90-day inhalation toxicity (rat) $300,000.0 $105,000.0 1,330.9 $350,000.0 $300,000.0

870.3700 Prenatal developmental toxicity study (rat and rabbit, preferred) $76,844.0 $26,895.4 340.9 $77,037.0 $76,844.0

870.3800 Reproduction and fertility effects (multigeneration) $378,479.0 $132,467.7 1,679.0 $381,233.0 $378,479.0

870.4100 Chronic tox (rodent and non-rodent) $950,000.0 $332,500.0 4,214.4 $1,100,000.0 $950,000.0

870.4200 Carcinogenicity (rat and mouse, preferred) $1,730,000.0 $605,500.0 7,674.6 $2,060,000.0 $1,730,000.0

870.4200 Carcinogenicity (microbials) $922,244.0 $322,785.4 4,091.2 $925,806.0 $922,244.0

870.5100 Bacterial reverse mutation assay $4,057.0 $1,420.0 18.0 $4,457.0 $4,057.0

870.5300 In vitro mammalian cell gene mutation test $18,654.0 $6,528.9 82.8 $19,767.0 $18,654.0

870.5375 In vitro mammalian chromosomal aberration test $0.0 $0.0 0.0 $0.0 $0.0

870.5380 Mammalian spermatogonial chromosomal aberration test $19,382.0 $6,783.7 86.0 $19,382.0 $19,382.0

870.5385 Mammalian bone marrow chromosomal aberration test $30,004.0 $10,501.4 133.1 $30,004.0 $30,004.0

870.5395 Mammalian erthrocyte micronucleus test $20,477.0 $7,167.0 90.8 $20,594.0 $20,477.0

none

Reference list of all studies/papers known to the applicant concerning 

mutagenicity $418.0 $146.3 1.9 $418.0 $418.0

870.5450 Rodent dominant lethal assay $0.0 $0.0 0.0 $0.0 $0.0

870.5500 Bacterial DNA damage or repair tests $0.0 $0.0 0.0 $0.0 $0.0

870.5550 Unscheduled DNA synthesis in mammalian cells in culture $30,000.0 $10,500.0 133.1 $0.0 $0.0

870.6100 Acute and 28 day delayed neurotoxicity organophosphorus substances (hen) $79,375.0 $27,781.3 352.1 $80,625.0 $72,125.0

870.6200 Acute neurotoxicity (rat) $89,596.0 $31,358.6 397.5 $91,680.0 $87,513.0

870.6200 90-day Neurotoxicity (rat) $184,039.0 $64,413.7 816.4 $186,410.0 $181,668.0

870.6300 Developmental neurotoxicity study $406,904.0 $142,416.4 1,805.1 $417,135.0 $396,904.0

870.6500 Schedule-controlled operant behavior $164,000.0 $57,400.0 727.5 $164,000.0 $164,000.0

870.6850 Peripheral nerve function $110,000.0 $38,500.0 488.0 $110,000.0 $110,000.0

870.6855 Neurophysiology: sensory evoked potentials $110,000.0 $38,500.0 488.0 $110,000.0 $110,000.0

870.7200 Companion animal safety $156,000.0 $54,600.0 692.0 $167,667.0 $144,333.0

870.7485 Metabolism and pharmacokinetics $182,729.0 $63,955.2 810.6 $217,729.0 $147,729.0

870.7600 Dermal penetration $147,529.0 $51,635.2 654.5 $175,346.0 $119,711.0

870.7800 Immunotoxicity $56,648.0 $19,826.8 251.3 $57,731.0 $55,565.0

Occupational and Residential Exposure

875.1100 Dermal outdoor exposure $167,857.0 $58,750.0 744.6 $192,143.0 $143,571.0

875.1200 Dermal indoor exposure $126,429.0 $44,250.2 560.9 $150,714.0 $102,143.0

875.1300 Inhalation outdoor exposure $164,286.0 $57,500.1 728.8 $181,429.0 $147,143.0

875.1400 Inhalation indoor exposure $126,429.0 $44,250.2 560.9 $150,714.0 $102,143.0

875.1500 Biological monitoring $188,393.0 $65,937.6 835.7 $219,256.0 $157,500.0

875.1600 Application exposure data reporting and calculations $7,500.0 $2,625.0 33.3 $10,000.0 $5,000.0

875.1700 Product use information $3,000.0 $1,050.0 13.3 $4,000.0 $2,000.0

875.2100 Dislodgeable foliar residue dissipation and turf transferable residues $55,100.0 $19,285.0 244.4 $56,100.0 $54,100.0

875.2200 Soil residue dissipation $83,125.0 $29,093.8 368.8 $85,000.0 $81,250.0

875.2300 Indoor surface residue dissipation $35,000.0 $12,250.0 155.3 $35,000.0

875.2400 Dermal exposure $125,500.0 $43,925.0 556.7 $133,000.0 $118,000.0

875.2500 Inhalation exposure $73,000.0 $25,550.0 323.8 $81,000.0 $65,000.0

875.2600 Biological monitoring $166,875.0 $58,406.3 740.3 $191,667.0 $142,083.0

875.2700 Product use information $3,000.0 $1,050.0 13.3 $4,000.0 $2,000.0
Page 28 of 30

875.2800 Description of human activity $3,000.0 $1,050.0 13.3 $4,000.0 $2,000.0

875.2900 Data reporting and calculations $3,000.0 $1,050.0 13.3 $4,000.0 $2,000.0

875.3000 Nondietary ingestion exposure $75,000.0 $26,250.0 332.7 $83,333.0 $66,667.0

Environmental Fate

none Use Profile $251.0 $0.0 0.0 $334.0 $167.0

835.1230 Sediment and soil adsorption/desorption $23,750.0 $8,312.5 105.4 $24,583.0 $22,917.0

835.1240 Leaching and adsorption/desorption $46,780.0 $16,373.0 207.5 $51,880.0 $41,680.0

835.1410 Laboratory volatility $45,000.0 $15,750.0 199.6 $5,000.0 $40,000.0

835.2120 Hydrolysis $25,230.0 $8,830.5 111.9 $29,900.0 $20,560.0

835.2240 Photodegradation in water $46,875.0 $16,406.3 207.9 $47,875.0 $47,875.0

835.2370 Photodegradation in air $110,000.0 $38,500.0 488.0 $120,000.0 $100,000.0

835.2410 Photodegradation on soil $42,350.0 $14,822.5 187.9 $45,183.0 $39,517.0

835.4100 Aerobic soil metabolism $94,375.0 $33,031.3 418.7 $98,625.0 $90,125.0

835.4200 Anaerobic soil metabolism $71,300.0 $24,955.0 316.3 $71,300.0 $71,300.0

835.4300 Aerobic aquatic metabolism $44,475.0 $15,566.3 197.3 $47,350.0 $41,600.0

835.4400 Anaerobic aquatic metabolism $80,900.0 $28,315.0 358.9 $86,525.0 $72,275.0

835.6100 Terrestrial field dissipation $317,767.0 $111,218.5 1,409.7 $366,067.0 $269,467.0

835.6200 Aquatic field dissipation $267,250.0 $93,537.5 1,185.6 $354,000.0 $180,500.0

835.6300 Forestry dissipation $275,500.0 $96,425.0 1,222.2 $362,500.0 $188,500.0

835.6400 Combination and tank mixes $219,200.0 $76,720.0 972.4 $219,200.0

835.8100 Field volatility $230,900.0 $80,815.0 1,024.3 $230,900.0

835.7100 Groundwater Monitoring $1,225,000.0 $428,750.0 5,434.3 $2,000,000.0 $450,000.0

none Monitoring of representative U.S. waters $215,833.0 $75,541.6 957.5 $263,333.0 $168,333.0

none Leaching study $43,000.0 $15,050.0 190.8 $48,000.0 $38,000.0

Residue Chemistry

860.1100 Chemical identity $1,250.0 $437.5 5.5 $2,000.0 $500.0

860.1200 Directions for use $4,000.0 $1,400.0 17.7 $5,000.0 $3,000.0

860.1300 Nature of the residue in plants $100,000.0 $35,000.0 443.6 $105,000.0 $95,000.0

860.1300 Nature of the residue in livestock $105,833.0 $37,041.6 469.5 $118,333.0 $93,333.0

860.1340 Residue analytical method - plants $22,125.0 $7,743.8 98.2 $23,250.0 $19,000.0

860.1340 Residue analytical method - livestock $65,500.0 $22,925.0 290.6 $76,800.0 $54,200.0

860.1360 Multiresidue method $24,000.0 $8,400.0 106.5 $25,667.0 $22,333.0

860.1380 Storage stability data $18,500.0 $6,475.0 82.1 $18,500.0 $18,500.0

860.1400 Water $53,750.0 $18,812.5 238.4 $55,000.0 $52,500.0

860.1400 Fish $104,000.0 $36,400.0 461.4 $130,000.0 $78,000.0

860.1400 Irrigated crops (one-crop) $18,000.0 $6,300.0 79.9 $20,500.0 $15,500.0

860.1460 Food handling $205,000.0 $71,750.0 909.4 $230,000.0 $180,000.0

860.1480 Meat/milk/poultry/eggs $149,000.0 $52,150.0 661.0 $152,333.0 $145,667.0

860.1500 Crop field trials $163,667.0 $57,283.5 726.1 $177,000.0 $150,333.0

860.1520 Processed food/feed $35,000.0 $12,250.0 155.3 $37,333.0 $32,667.0

860.1540 Reduction of Residues $15,000.0 $5,250.0 66.5 $20,000.0 $10,000.0

860.1550 Proposed tolerance $5,363.0 $1,877.1 23.8 $6,600.0 $4,124.0
Page 29 of 30

860.1560 Reasonable grounds in support of the petition $10,000.0 $3,500.0 44.4 $15,000.0 $5,000.0

860.1650 Submittal of analytical reference standards $334.0 $116.9 1.5 $501.0 $167.0

860.1850 Confined accumulation in rotational crops $249,845.0 $87,445.8 1,108.4 $269,845.0 $229,845.0

860.1900 Field accumulation in rotational crops $137,500.0 $48,125.0 610.0 $125,000.0 $150,000.0

none Migration Studies $105,000.0 $36,750.0 465.8 $120,000.0 $90,000.0

Microbial Pesticides

880.1100 Product identity $233.0 $81.6 1.0 $300.0 $165.0

880.1200 Description materials, production, formulation $908.0 $317.8 4.0 $1,650.0 $165.0

880.1400 Discussion of formation of impurities $330.0 $115.5 1.5 $495.0 $165.0

880.3800 Immune Response $85,000.0 $29,750.0 377.1 $100,000.0 $70,000.0

880.4350 Non-target insect testing $15,000.0 $5,250.0 66.5 $18,000.0 $12,000.0

880.4425 Dispenser - water leaching $25,000.0 $8,750.0 110.9 $30,000.0 $20,000.0

Hypersensitivity incidents $825.0 $288.8 3.7 $1,320.0 $330.0

885.1100 Product Identity $5,000.0 $1,750.0 22.2 $8,000.0 $2,000.0

885.1200a Manufacturing process $3,500.0 $1,225.0 15.5 $5,000.0 $2,000.0

885.1200b Deposition of samples $3,500.0 $1,225.0 15.5 $5,000.0 $2,000.0

885.1300 Discussion of formulation of unintentional ingredients $3,500.0 $1,225.0 15.5 $5,000.0 $2,000.0

885.1400 Analysis of samples $74,500.0 $26,075.0 330.5 $145,000.0 $4,000.0

885.1500 Certification of limits $350.0 $122.5 1.6 $500.0 $200.0

885.2000 Background for residue analysis of microbial pest control agents $0.0 $0.0 0.0 $0.0 $0.0

885.2100 Chemical identity $660.0 $231.0 2.9 $825.0 $495.0

885.2200 Nature of the residue in plants $108,333.0 $37,916.6 480.6 $108,333.0 $108,333.0

885.2250 Nature of the residue in animals $117,144.0 $41,000.4 519.7 $123,750.0 $110,538.0

885.2300 Analytical method - plants $26,540.0 $9,289.0 117.7 $34,040.0 $19,040.0

885.2350 Analytical method - animals $43,908.0 $15,367.8 194.8 $56,325.0 $31,492.0

885.2400 Storage stability, plants $31,017.0 $10,856.0 137.6 $32,683.0 $29,350.0

885.2500 Magnitude of residue in plants $137,160.0 $48,006.0 608.5 $137,587.0 $136,733.0

885.2550 Magnitude of residue in meat/milk/poultry $157,663.0 $55,182.1 699.4 $162,425.0 $152,900.0

885.2600 Magnitude of residue in potable water, fish, and irrigated crops $221,442.0 $77,504.7 982.4 $245,225.0 $197,658.0

885.3000 Background Mammalian Infectivity/pathogenicity analysis $250,000.0 $87,500.0 1,109.0 $250,000.0 $250,000.0

885.3050 Acute oral toxicity/pathogenicity $33,500.0 $11,725.0 148.6 $41,000.0 $25,000.0

885.3150 Acute pulmonary toxicity/pathogenicity $37,500.0 $13,125.0 166.4 $50,000.0 $25,000.0

885.3200 Acute injection toxicity/pathogenicity (intravenous) $37,500.0 $13,125.0 166.4 $50,000.0 $25,000.0

885.3200 Acute injection toxicity/pathogenicity (intraperitoneal) $12,500.0 $4,375.0 55.5 $18,000.0 $7,000.0

885.3400 Hypersensitivity incidents $800.0 $280.0 3.5 $1,300.0 $300.0

885.3500 Cell Culture $30,000.0 $10,500.0 133.1 $35,000.0 $25,000.0

885.3550 Acute toxicity, TI $21,500.0 $7,525.0 95.4 $40,000.0 $3,000.0

885.3600 Subchronic toxicity/pathogenicity $150,000.0 $52,500.0 665.4 $200,000.0 $100,000.0

885.3650 Reproductive/fertility effects $162,500.0 $56,875.0 720.9 $20,000.0 $125,000.0

885.4050 Avian Oral, TI $15,000.0 $5,250.0 66.5 $18,000.0 $12,000.0

885.4100 Avian Inhalation toxicity/pathogenicity, TI $16,000.0 $5,600.0 71.0 $20,000.0 $12,000.0

885.4150 Wild mammal toxicity/pathogenicity,TI $65,000.0 $22,750.0 288.4 $80,000.0 $50,000.0

885.4200 Freshwater fish toxicity/pathogenicity,TI $37,500.0 $13,125.0 166.4 $45,000.0 $30,000.0

885.4240 Freshwater invertebrate toxicity/pathogenicity,TI $37,500.0 $13,125.0 166.4 $45,000.0 $30,000.0
Page 30 of 30

885.4280 Estuarine/marine animal testing, TI $40,000.0 $14,000.0 177.4 $48,000.0 $32,000.0

885.4280 Estuarine/marine invertebrate testing,TI $40,000.0 $14,000.0 177.4 $48,000.0 $32,000.0

885.4300 Nontarget plant studies, TI $30,000.0 $10,500.0 133.1 $40,000.0 $20,000.0

885.4380 Honey bee testing $4,250.0 $1,487.5 18.9 $5,000.0 $3,500.0

885.4600 Avian chronic pathogenicity and reproduction, TIII $175,000.0 $61,250.0 776.3 $200,000.0 $150,000.0

885.4650 Aquatic invertebrate range testing,TIII $75,000.0 $26,250.0 332.7 $1,000.0 $50,000.0

885.4700 Fish life cycle studies,TIII $250,000.0 $87,500.0 1,109.0 $300,000.0 $200,000.0

885.4750 Aquatic ecosystem test $350,000.0 $122,500.0 1,552.7 $400,000.0 $300,000.0

885.5200 Terrestrial environmental expression tests $95,000.0 $33,250.0 421.4 $150,000.0 $40,000.0

885.5300 Freshwater environmental expression test $0.0 $0.0 0.0 $0.0 $0.0

885.5400 Marine or estaurine environmental expression tests $95,000.0 $33,250.0 421.4 $150,000.0 $40,000.0

Notes:

Labor Rates in 2003 dollars, but data collected represents 2003 -2007

Clerical: $40/hr

Technical: $88/hr

Management: $130/hr 

Color Code:

Study has no cost estimate, source or year

Test cost estimate has no source or year